Avandia Side Effects Lawsuit News Archive

GlaxoSmithKline sued over risks associated with Avandia
- Louisiana Record
12/27/2011 - A St. Tammany Parish resident has filed a lawsuit against GlaxoSmithKline for its alleged failure to warn about risks associated with the antidiabetic drug Avandia. John Anderson and Connie Anderson filed suit on Dec. 21 in federal court in New Orleans. GlaxoSmithKline is accused of misrepresenting, concealing and failing to disclose to physicians and patients, information regarding the safety and effectiveness of Avandia.
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Judge Pushes to Resolve Avandia Product Liability Claims
Judge Appoints Mediator to Avandia Product Liability Cases and Establishes a Time Limit in which The Cases Must Be Resolved Or They Will Begin Trials, Explains Ennis & Ennis, P.A.
- Ennis & Ennis
11/11/2011 - Bloomberg Businessweek is reporting U.S. District Judge Cynthia Rufe pushed GlaxoSmithKline (GSK) and the Plaintiffs yesterday to resolve most of the remaining Avandia diabetes medication patient lawsuits by appointing a mediator to preside over settlement negotiations for an unspecified number of Avandia cases consolidated before her in Philadelphia (In re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court, Eastern District of Pennsylvania). According to Ennis & Ennis, P.A., the Honorable Cynthia Rufe set a 75-day deadline to resolve 85 percent of the remaining cases.
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Glaxo Facing Mediation Push to Resolve Avandia Lawsuits
- Bloomberg
11/09/2011 - GlaxoSmithKline which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication.
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Avandia Drug Maker Agrees to Pay $3 Billion Settlement
Ennis & Ennis, P.A. explains the potential “Big Pharma” settlement.
- Ennis & Ennis
11/07/2011 - British pharmaceutical company, GlaxoSmithKline (GSK), agreed to pay the US government $3 billion to settle criminal and civil investigations, reports Ennis & Ennis, P.A. If approved, the federal settlement will be the largest settlement for GSK, which is accused of illegally pushing its drugs.
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Glaxo to Pay $3 Billion to Settle U.S. Sales, Avandia Cases
- Bloomberg
11/04/2011 - GlaxoSmithKline Plc agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
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Avandia MDL Judge Denies Avandia Statute of Limitations Motion to Dismiss
- Ennis & Ennis
09/23/2011 - U.S. District Judge Cynthia M. Rufe, the presiding judge on the federal Avandia litigation cases, denied GlaxoSmithKline’s Statute of Limitations Motion to Dismiss. GlaxoSmithKline (GSK), the manufacturer of Avandia, filed a Motion to Dismiss over 60 lawsuits, wherein the Plaintiffs allege the drug caused heart problems, arguing that the statute of limitations had expired on these claims.
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Diabetes medicine Avandia taken off market
- Sowetan
07/07/2011 - The medication, Avandia, is prescribed by doctors to some Type 2 diabetics and is produced by GlaxoSmithKline. The MCC made the decision five weeks ago, "due to safety risks" caused by rosiglitazone which is contained in the medicine. A statement released by the MCC on Tuesday said: "Rosiglitazone is associated with an increased risk ... adverse events including heart failure, myocardial infarction (heart attack) and cardiac arrest".
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FDA Moves to Restrict Access to Three GSK Diabetes Drugs
- Diabetes Heath
06/13/2011 - The U.S. Food and Drug Administration has said that starting on November 18, 2011, it will restrict retail pharmacy sales of three diabetes drugs manufactured by GlaxoSmithKline: the stand-alone Avandia (rosiglitazone) and the combination drugs Avandamet (rosiglitazone and metformin) and Avandaryl (rosiglitazone and glimepiride). The market restrictions are motivated by the agency's concerns that the drugs increase the risk of heart attacks.
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Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies
- Bloomberg
05/19/2011 - GlaxoSmithKline Plc (GSK)’s diabetes drug Avandia will be pulled from U.S. pharmacies in November and available only through a special program, the Food and Drug Administration said.
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Glaxo updates Avandia labels
- WTNH.com
02/08/2011 - GlaxoSmithKline PLC said Monday it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.
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Glaxo Settles U.S. Federal Avandia Drug Case
- WSJ.com
01/31/2011 - GlaxoSmithKline PLC said it settled on the eve of a U.S. federal court case alleging that its Avandia diabetes drug led to the death of a man from a heart attack.
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Glaxo Faces First of Many Possible Avandia Trials
- DailyFinance.com
01/25/2011 - The first federal trial over whether GlaxoSmithKline's (GSK) blockbuster diabetes drug Avandia caused a fatal heart attack started Monday morning in Philidelphia, reported the Am Law Litigation Daily. Although Glaxo settled some 10,000 Avandia cases last summer -- for an average of $46,000 -- as many as 50,000 more lurk in the wings.
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Utah Sues Maker of Diabetes Drug Avandia
- ConsumerAffairs.com
11/17/2010 - Utah has field suit against GlaxoSmithKine (GSK), saying it illegally marketed its drug Avandia as a "wonder drug” to fight type 2 diabetes. Utah Attorney General Mark Shurtleff says the suit was filed because consumers were misled by the sale and promotion of the diabetic medication.
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Glaxo Subpoenaed On Avandia in U.S.
- WSJ
11/05/2010 - GlaxoSmithKline PLC said net profit fell 3.5% in the third quarter due to frugal government health-care spending and other factors, and disclosed that it has been subpoenaed by U.S. authorities examining its diabetes drug Avandia.
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GlaxoSmithKline to Pay $750M Fine for Sale of Bad Drugs
- AOL.com
10/27/2010 - Another day, another hard pill to swallow for GlaxoSmithKline. On Tuesday, the pharmaceutical giant agreed to pay $750 million to settle a government lawsuit alleging that the company sold defective and potentially dangerous medication.
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F.D.A. Adds Restrictions To Diabetes Drug Avandia Due To Side Effects
- WJBF.com
09/30/2010 - Diabetes affects millions of Americans in two ways....either they have type 1, where the body fails to produce insulin.....or type 2, when the body fails to use insulin properly.
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F.D.A. to Severely Restrict the Diabetes Drug Avandia
- NY Times
09/23/2010 - In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, will no longer be widely available.
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EU Agency Poses New Questions On Glaxo's Avandia
-NY Times
09/08/2010 - The European Medicines Agency said it was asking GlaxoSmithKline additional questions about its diabetes drug Avandia before giving a final verdict later this month on whether it should stay on the market.
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Glaxo Memo On Avandia Questioned
-NY Times
08/20/2010 - Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.
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Long Term Avandia Study Put On Hold By FDA
-CNN
07/26//2010 - A long-term study on the safety of a popular diabetes drug was put on hold Wednesday by the Food and Drug Administration, while the FDA considers whether it’s too dangerous to continue. Several large studies have linked the drug, Avandia, to a higher risk of heart attacks and other heart problems.
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Doctors Say It's Already Over For Diabetes Drug Avandia
-USA Today
07/20//2010 - In the grand scheme of treating diabetes, it might not matter much whether the Food and Drug Administration halts sales of the drug Avandia due to serious Avandia side effects.
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FDA: Avandia Should Stay With Restrictions
-LA Times
07/15//2010 - A sharply divided advisory committee recommends that the diabetes drug, which has been linked to increased heart attack risk, remain on the market with more supervision and stronger warnings.
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Diabetes Drug Maker Hid Test Data, Files Indicate
-NY Times
07/13//2010 - Diabetes Drug Maker Hid Test Data, Files IndicateIn the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.
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Two new studies point to risks for people taking the diabetes drug Avandia
-Washington Post
06/29//2010 -Two teams of researchers have produced powerful new evidence that the diabetes drug Avandia increases the risk of heart problems and strokes, renewing questions about the safety of the medication.
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Glaxo Settles More Avandia Lawsuits In U.S.
-Reuters
06/01//2010 - GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine.
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Recruiting Lags For Avandia Drug Trial
-Wall Street Journal
05/20/2010 - GlaxoSmithKline PLC is facing difficulties recruiting patients in the U.S. for a large clinical trial of its diabetes drug Avandia, in the wake of several studies linking Avandia to an increased risk of heart attack.
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U.S. Group Urges FDA To End Avandia Study
-Reuters
05/11/2010 - An major trial of Avandia puts patients at risk and should be stopped, a U.S. advocacy group said on Tuesday in calling on regulators to halt the global study of the controversial GlaxoSmithKline Plc diabetes drug.
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Glaxo Said To Pay $60 Million In Avandia Settlements
-Bloomberg
05/10/2010 - GlaxoSmithKline PLC agreed to pay about $60 Million in the first settlements of lawsuits alleging the company's Avandia diabetes drug causes heart attacks and strokes in some users, people familiar with the accords say.
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Avandia Trial in Trouble
-PharmExec
04/21/2010 - GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials. The TIDE trial, which received approval in 2007, pits Avandia (rosiglitazone) against Takeda’s Actos (pioglitazone), a drug that as yet hasn’t suffered from the same safety pitfalls.
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Avandia testing faces new questions
- Philadelphia Inquirer
04/20/2010 - U.S. regulators are reviewing the safety of GlaxoSmithKline P.L.C.'s Avandia diabetes drug as they weigh whether to suspend a trial testing the medicine, Bloomberg News reported. The Food and Drug Administration is reassessing a study comparing Avandia with a rival medicine from Takeda Pharmaceutical Co., and whether it is ethical to pursue the research after studies tied the Glaxo drug to an increased heart attack risk, according to a letter from FDA Commissioner Margaret Hamburg, dated March 30, the news service said.
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FDA Weighs Halting Avandia Safety Study
-The Wall Street Journal
04/19/2010 - The Food and Drug Administration is weighing whether to halt a safety study involving thousands of patients taking GlaxoSmithKline PLC's Avandia diabetes drug, a decision that could also determine whether the drug stays on the U.S. market. Studies during the past three years have tied the medicine to an increased risk of heart attacks.
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Study Sees a Slant in Articles on Drug
-New York Times
04/15/2010 - A new analysis of reviews and articles about the controversial diabetes drug Avandia has found that experts who were paid by its manufacturer have been significantly more likely than others to draw positive conclusions about the drug’s safety and efficacy.
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Avandia and the Heart: A Reminder That Drugs Can Harm
-The Huffington Post
03/31/2010 - Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart.
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Is Avandia Harmful for The Heart?
-HSJ
03/25/2010 -Avandia is a diabetes drug that is usually given to senior citizens. It helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin. Avandia is for people with Type 2 (non-insulin dependent) diabetes. It is sometimes used in combination with other medications, but it is not for treating Type 1 diabetes. 
However, there are recent studies that Avandia is harmful for the heart, and increases the chances of getting a heart attack.
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Saudi Arabia suspends Glaxo diabetes drug Avandia
-Reuters
03/22/2010 - Saudi Arabia has suspended GlaxoSmithKline's (GSK.L) diabetes drug Avandia for six months, arguing that potential heart risks outweigh its benefits. The Saudi Food and Drug Authority (SFDA) was the first healthcare regulator to take such action. Its decision means detailing and advertising of Avandia is banned and patients on Avandia will be referred to their doctor for consultation.
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Many Avandia defenders have drug co. ties –study
-Reuters
03/19/2010 - Virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday.
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UBS Says Avandia lawsuits pose up to $6B risk to GS
-Ennislaw
03/15/2010 - The UBS (Union Bank of Switzerland) reported publicly last week that pharmaceutical giant GlaxoSmithKline PLC could end up liable for more than $6 billion in settlements and compensation for serious health complications caused by the company’s popular diabetes treatment medication Avandia. The type-2 diabetes prescription drug has been linked with severe heart problems, including heart attacks.
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Rosiglitazone - A lifesaver or killer drug?
-DNA
03/08/2010 - With its alarming rise and high number of diabetes cases, India is called the diabetes capital of the world — the sugar disease is emerging as an enormous health problem in the country. Various studies have shown that the high incidence of diabetes in India is mainly because of sedentary lifestyle, lack of physical activity, obesity, stress and consumption of diets rich in fat, sugar and calories. Among the various drugs used to treat the disease, one of it is Rosiglitazone, which is used to treat type II diabetes. However, lately there has been some dispute over the effectiveness of the medicine and its side effects.
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More FDA Corruption
-AlterNet
03/08/2010 - FDA and Avandia a diabetes drug linked to 83,000 heart attacks. The FDA’s own research showed Avandia to be associated with a significant increase in heart attack risk, and yet the FDA did nothing to protect the public. The AMA admitted Avandia was dangerous. In its journal “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone (avandia) use for at least 12 months is associated with a significantly increase risk of myocardial infarction.”
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Questions raised about ongoing Avandia studies
CTV.ca
03/03/2010 - While health regulators in both Canada and the U.S. wrangle over what to do about the diabetes medication Avandia, some are raising concerns about why clinical studies are still recruiting patients to test the controversial drug. Avandia, or rosiglitazone as it's known generically, was once heavily promoted for Type 2 diabetes because it helps to lower blood-sugar levels in patients. But it has come under intense scrutiny in recent years.
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6 Things You Should Know About Avandia
-U.S.News
03/01/2010 - To the chagrin of many diabetics, the medication Avandia is back in the news because of its possible link to heart problems. A Senate Finance Committee report released on Saturday says that the drug's manufacturer, GlaxoSmithKline, knew the type 2 diabetes drug had possible harmful cardiac effects several years before a 2007 New England Journal of Medicine study initially raised concerns about Avandia. GSK, for its part, says in a press release that it rejects the report's findings, adding that the committee's conclusions on the safety of Avandia are "based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug."
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County files lawsuit against drug giant over diabetes medication
-Mercury News
03/01/2010 - Claiming that a major drugmaker made billions of dollars on a diabetes medication that caused heart attacks and strokes, Santa Clara County on Friday filed a lawsuit charging a decade of false advertising and seeking compensation on behalf of patients and providers in California.
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GSK to face FDA meeting over Avandia safety record
-The Independent
02/24/2010 - The Food and Drug Administration (FDA) will hold a public meeting on the possible heart risks of GlaxoSmith-Kline's (GSK) diabetes treatment Avandia in July, the US regulator said yesterday, but it urged doctors to continue prescribing the drug until any new advice was issued.
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Major Medical Alert: Diabetes drug Avandia responsible for monthly heart attacks and heart failures
-Examiner
02/24/2010 - Good Morning America reported that a Senate report released on Monday shows that the Diabetes drug Avandia is responsible for 500 heart attacks and 300 heart failures monthly. But yet, the FDA has not removed the drug from the market.
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Dr. Steven Nissen On Diabetic Drug, Avandia, Shown To Damage The Heart
-Vitals
02/23/2010 - Avandia, a controversial diabetes medication, was linked to 304 deaths in the third quarter of 2009 according to a confidential government report obtained by the New York Times. Dr. David Graham and Dr. Kate Gelperin of the FDA recommend that it be taken off the market.
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U.S. Urges Glaxo to Pull Avandia on Heart Risks
-Wall Street Journal
02/22/2010 - Confidential studies by Food and Drug Administration officials recommend that GlaxoSmithKline's Avandia, a diabetes medicine, get pulled from the market because it is linked to heart attacks. The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.), also say any head-to-head trial where patients get Avandia and Takeda Pharmaceutical Co.'s diabetes medicine Actos would be "unethical and exploitative."
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Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
-FDA Medwatch
02/22/2010 - FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis.
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Senate report links diabetes drug Avandia to heart attacks
-CNN
02/20/2010 - The diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years but worked to keep them from the public, according to a Senate committee report released Saturday.
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Remove Diabetes Drug Avandia From Market: FDA Reports
Controversial medicine Avandia raises users' heart risk, leaked documents suggest
HealthDay News
02/20/2010 - The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports. The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month.
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Controversial Diabetes Drug Avandia Harms Heart, U.S. Concludes
-The New York Times
02/19/2010 - Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
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Diabetes Drugs Avandia, Actos Tied to Fractures in Women
-The Palm Beach Post
02/15/2010 - Women who take diabetes drugs known as thiazolidinediones, which include Avandia and Actos, are at a greater risk of bone fractures, a new study finds. Women who took a thiazolidinedione drug for a year were 50 percent more likely to suffer a bone fracture than patients who didn't take the drug, the researchers found.
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Avandia Heart Attack Risks Lead To Side Effects Lawsuit Local resident's Avandia lawsuit part of national effort"
-Gary Post Tribune
12/30/2009 - A local resident's lawsuit against a drug maker for not properly warning patients about how its product increases the risk of heart attacks is joining hundreds of similar lawsuits across the country.
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Another suit filed against GSK over Avandia in St. Clair County
- St. Clair County Record
11/24/2009 - More than 30 people say GlaxoSmithKline was wrong in selling a diabetes drug without first warning of potential serious side effects from which they or their deceased relatives suffered.
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Arkansas man claims diabetes drug caused heart attack
-The Southeast Texas Record
11/19/2009 - An Arkansas man with diabetes but an otherwise clean bill of health claims his diabetes medication Avandia caused him to suffer a heart attack. Kenneth L. Bryan, 58, filed a personal injury lawsuit against GlaxosmithKline on Nov. 18 in the Texarkana Division of the Western District of Arkansas. Bryan states that around the same time he was given a clean bill of health in December 2003, he began taking the prescription drug Avandia.
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Diabetes drugs may leave heart at greater risk
Working harder to lower blood glucose in Type 2 diabetics doesn't help the heart, studies say.
-LA Times
10/24/2009 - Medications for Type 2 (adult-onset) diabetes are very effective at controlling blood sugar levels. You'd think, then, that the drugs would also be very effective at controlling complications of the disease related to those spikes in blood sugar: cardiovascular disease, kidney failure, blindness, nerve damage and amputation of limbs. Surprisingly, though, that has not turned out to be the case for cardiovascular events such as heart attacks and strokes.
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Confusing Choices for Doctors and Type 2 Diabetes Patients
-GEN
10/23/2009 - Given the current worldwide type 2 diabetes epidemic, it’s hard for drug developers to ignore the huge potential for new, better, and safer oral drugs. The U.S. market alone has reached $5 billion annually, and the prevalence of type 2 diabetes continues to rise across the globe.
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Thiazolidinediones have a role for appropriate diabetic patients
-Heartwire
10/20/2009 - Although the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial and other trials found that rosiglitazone (Avandia, GlaxoSmithKline) increases risk of heart failure and fractures, thiazolidinediones (TZDs) are still useful for appropriate diabetic patients.
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Study finds certain diabetes drugs may cause bone fractures
-DrugStoreNews
10/01/2009 - A certain class of diabetes drugs may put patients at higher risk of bone fractures, according to a study published in the online edition of the journal PLoS Medicine.
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Avandia Study Shows Increased Risk Of Heart Failure
-Ennis & Ennis, P.A.
09/28/2009 - Avandia is marketed by GlaxoSmithKline for the treatment of Type 2 diabetes. Recently however, studies have shown that Avandia significantly increases the risk of heart attack and heart related deaths.
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Diabetes drug could lead to heart failure: Study
-CalgaryHerald
09/26/2009 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos.
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Prescription Avandia Has Been Linked To Cases Of Serious Side Effects And Fatalities
The prescription drug Avandia (rosiglitazone) causes an increase in liver problems, heart problems and bone density problems resulting in fractures
-OfficialWire
09/24/2009 - The prescription drug Avandia (rosiglitazone) causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have taken Avandia should be aware of possible side effects and should know when to seek treatment for serious Avandia related health problems.
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Diabetes drug linked to heart failure risk
-UPI
08/25/2009 - Canadian scientists say they have discovered rosiglitazone (Avandia) a type 2 diabetes drug, might be linked with increased risk of heart failure and death. The scientists from the University of Toronto and the Sunnybrook Health Sciences Center in Toronto, said the linkage was found among older patients, compared to a similar drug, pioglitazone (Actos).
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Researchers decry use of diabetes drug Avandia
-The Canadian Press
08/23/2009 - Some Ontario researchers are calling into question the continued use of the controversial diabetes drug Avandia, saying a competing drug in the same class is as effective and less dangerous. The scientists, from Toronto's Institute for Clinical Evaluative Sciences, said people taking Actos or pioglitazone for Type 2 diabetes are 23 per cent less likely to be hospitalized for heart failure and 14 per cent less likely to die than people taking Avandia or rosiglitazone.
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Rosiglitazone safety questioned, again, this time in population-based study
-TheHeart.org
08/20/2009 - Toronto, ON - The risk of dying or being hospitalized with heart failure, but not of MI, is lower among older diabetic patients taking pioglitazone (Actos, Takeda Pharmaceuticals North America) than in those taking rosiglitazone (Avandia, GlaxoSmithKline), suggests a retrospective analysis based on outpatient data from across Ontario.
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Stop prescribing killer diabetes drug, scientists warn:
Rosiglitazone, brand name Avandia, has higher rates of heart failure and death than similar alternative
-Guardian UK
08/20/2009 - Scientists say doctors should stop prescribing a commonly used diabetes drug, after studies show that it is linked to higher rates of heart failure and death than a similar alternative.
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Glaxo's Avandia riskier than Takeda drug -study
-Reuters
08/19/2009 - GlaxoSmithKline Plc's diabetes drug Avandia is associated with an increased risk of heart failure and death among older patients compared with Takeda Actos, according to Canadian research.
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Diabetes drug could lead to heart failure: Study
-The Vancouver Sun
08/19/20019 - New research involving nearly 40,000 Ontario patients is questioning the use of a widely prescribed diabetes drug that an expert in drug safety says should be removed from the market. The study, published this week by the British Medical Journal, found that rosiglitazone — sold under the brand name Avandia — is associated with an increased risk of heart failure and death compared to a similar drug, pioglitazone, or Actos.
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TZDs may increase risk for fracture in men, women
-Endocrine Today
08/17/2009 - Men and women who are exposed to thiazolidinediones may be at increased risk for fractures, especially with pioglitazone. A prospective cohort study examined risk for fractures in 84,339 adults (mean age, 59; 43% women) from British Columbia, Canada, who began treatment with a TZD or sulfonylurea.
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Diabetes drug Avandia comes under new criticism
-LA Times
07/25/2009 - The diabetes drug rosiglitazone, already under fire because it has been found to increase the risk of heart attacks, can also produce liver failure and death in some patients, researchers from the activist group Public Citizen said this week.
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No new Alzheimer's indication for Avandia
-FiercePharma
07/13/2009 - Poor Avandia. The GlaxoSmithKline drug failed an Alzheimer's disease trial, dashing the company's hopes of a new indication and up to $300 million in additional sales. "We saw no efficacy in this study, or the two adjunct trials," Michael Gold, Glaxo's vice president of neurosciences, told Bloomberg.
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Glaxo’s Avandia Fails to Benefit Alzheimer’s Patients in Study
-Bloomberg
07/12/2009 - GlaxoSmithKline Plc’s diabetes drug Avandia failed to benefit patients with Alzheimer’s disease, according to a company-funded study. The findings are another setback for Avandia, once the biggest-selling drug for diabetes in the world, and raise questions about the theory that Alzheimer’s is a form of diabetes of the brain. Sales of Avandia haven’t recovered since a study linked the drug to heart attacks in May 2007. READ MORE::

5 Risks Linked to Diabetes Medications Like Lantus, Avandia, Actos: Cancer, heart failure, fractures, and eye and liver problems among some diabetes drugs' possible risks
-U.S.News
07/07/2009 - For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain diabetes drugs. Recent concerns that Avandia (rosiglitazone) might cause cardiovascular problems, for example, have led some experts to call for it to be pulled from the market, although it remains available today.
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Diabetes debate
-Indian Express
07/06/2009 - In a new study, GlaxoSmithKline refuses to accept the claim that its product Avandia puts patients at high risk of heart attacks; diabetologists say the final word is not yet out.
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FDA wants additional study of diabetes drug
-ChicagoTribune
06/27/2009 - In a blow to the diabetes treatment franchise of a Deerfield drug maker, the U.S. Food and Drug Administration has asked Takeda Pharmaceuticals North America Inc. to conduct an additional heart safety trial of its experimental drug alogliptin, the company said this afternoon.
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Diabetes drugs can lead to heart failure
-TheMedGuru
06/25/2009 - A latest study has revealed how a certain category of diabetes drugs can actually increase the risk of heart failure. The class of drugs under study were thiazolidinediones (TZDs).
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How diabetes drugs raise heart failure risk
-ThaindianNews
06/23/2009 - A new study may help explain how a class of diabetes drugs increases the risk of heart failure. Thiazolidinediones (TZDs) have been controversial since a 2007 analysis of Avandia (rosiglitazone), a TZD made by GlaxoSmithKline, suggested that patients taking it are at higher risk of heart attack.
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GSK: RECORD trial results do not change Avandia’s CV risk stigma, bone fracture risk, physicians say
-Pharmawire
06/19/2009 - The final results of the RECORD study demonstrated that overall rates of cardiovascular (CV) hospitalization and cardiovascular death - the two primary endpoints - were similar in patients taking Avandia (rosiglitazone) compared to those receiving metformin and sulfonylurea.
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Recent study links Avandia and Actos to increased bone breaks
-Examiner - Knoxville
06/15/2009 - Be careful!Dr. Merri Pendergrass presented a study of bone fractures in close to 70,000 patients taking either rosiglitazone (Avandia) or pioglitazone (Actos) at the 2009 American Diabetes Association Scientific Sessions. Fracture risk appears to be increased by 40% for patients taking these medications.
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More evidence links glitazones to broken bones
-WebMD – theheart.org
06/13/2009 - New Orleans, LA - The largest study to date looking at whether the risk of bone fractures is increased in the setting of thiazolidinedione drugs (TZDs) suggests that fracture risk is more than 40% higher in people taking TZDs and that both men and women are vulnerable.
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Docs say Avandia fears aren't laid to rest
-FiercePharma
06/09/2009 - Doctors aren't so sure that the Avandia-exonerating safety study is as conclusive as presented at the American Diabetes Association meeting. Some physicians are calling the study "flawed." In an editorial in the Lancet--where the research was published--two doctors wrote that the study's limitations prevent any "definitive conclusions" about Avandia's effects on cardiac safety.
READ MORE::

Avandia Raises Risk of Heart Failure, Fractures
But study found diabetes drug didn't increase chances of heart disease, death
-HealthDay News
06/08/2009 - The diabetes drug Avandia significantly raises the risk of both heart failure and bone fractures, but it does not boost the odds for either cardiovascular disease or death, new research has found.
READ MORE::

Suit against GSK claims Avandia not worth the risks
-SoutheastTexasRecord
05/14/2009 - After taking Avandia for five years, Frank Casteel underwent heart bypass surgery in 2007. Now Casteel is suing the drug's manufacturer alleging that the drug is not worth the risks.
READ MORE::

10 Utahns, 2 others sue pharmaceutical company
-Deseret News
05/02/2009 - Ten Utahns and two people from Oregon filed federal lawsuits Thursday against the pharmaceutical giant GlaxoSmithKline PLC alleging that the company was negligent in researching the drug Avandia, which caused them (or a spouse) to have heart attacks and subsequent health problems.
READ MORE::

Low blood sugar a dementia risk for diabetics
-The Malaysian Insider.
04/14/2009 - Older diabetics whose blood sugar drops to dangerously low levels have a higher risk of developing dementia, US researchers said today. The study by researchers at Kaiser Permanente in Oakland, California, suggests that aggressive blood sugar control resulting in blood sugar so low it requires a trip to the hospital may increase dementia risks in older adults with type 2 diabetes.
READ MORE::

Certain Diabetes Drugs May Pose Eye Risk
-Forbes
04/13/2009 - A class of diabetes drugs called glitazones are associated with an increased risk of a vision-threatening complication called diabetic macular edema (DME), which features swelling and fluid accumulation in the retina.
READ MORE::

Diabetes drug class linked to vision-threatening complication
-EurekAlert
04/02/2009 - Treatment with the glitazone class of diabetes drugs leads to a "modest" increase in the risk of diabetic macular edema (DME)—a common complication that can lead to vision loss, reports a study in the April issue of the American Journal of Ophthalmology (http://www.elsevier.com/locate/ajo), published by Elsevier.
READ MORE::

Avandia Causing Havoc For Patients
-LawyersandSettlements
03/18/2009 - Centerview, MO: As more lawsuits are filed against the maker of Avandia alleging the drug caused irreparable harm to patients, more patients are wondering if they too have suffered an Avandia heart attack or other Avandia side effects. Meanwhile, public interest groups are encouraging patients to avoid the drug and return to older medications that do not have as many complications.
READ MORE::

Review of Heart Side Effects for Diabetes Drugs Lead to Delay for Proposed Takeda Medication
-AboutLawsuits
03/09/2009 - Following the discovery of heart problems with Avandia and other diabetes drugs, the FDA is requiring that drug makers establish that proposed diabetes medications do not increase the risk of cardiovascular side effects, even if the New Drug Application was filed before the new guidance was issued in December 2008.
READ MORE::

Avandia Health Problems "Frustrating"
-LawyersandSettlements
02/12/2009- Pine Mountain Valley, GA: Dave J. (not his real name) says he is not sure how long he took Avandia for, but he says he was definitely on the medication for a while. Since he took Avandia, Dave has had a number of medical problems, including at least one massive stroke. Following his medical problems, Dave has been unable to return to any of his jobs, which included being a high school teacher, an adjunct professor and a part-time deputy with the sheriff's office.
READ MORE::

Heart risk of diabetes drugs
-BMJ Group
01/21/2009- Two medicines used to treat people with diabetes can increase the risk of serious side effects, new research has found. Rosiglitazone (brand name Avandia) and pioglitazone (Actos) are medicines for type 2 diabetes.
READ MORE::

Glaxo EMails Show That Scientist Knew About Avandia
-InjuryBoard
01/14/2009-The Wall Street Journal reported on January 14 that internal emails from GlaxoSmithKline's scientists show that at the time that Glaxo was publically dismissing the notion that its diabetes drug, Avandia, posed an increased risk of heart attacks, its own scientists expressed concerns that Glaxo's own data was showing the same thing.
READ MORE::

FDA wants closer scrutiny of new diabetes drugs:
With type 2 diabetes already increasing heart risks, the FDA is seeking assurances that new drugs won't do further damage.
-AMNews
01/12/2008- Washington -- The Food and Drug Administration is asking the manufacturers of new drugs and biologics for type 2 diabetes to be more diligent in determining if their therapies pose cardiovascular risks.
READ MORE::

Bone risk from diabetes drug
-NortWalesChronicle
12/23/2008- The Daily Mail today reports that regular use of a group of diabetes drugs, "doubles the chances of fractures in female patients," and could "more than double the risk of heart failure".
READ MORE::

Actos Heart Failure Warning Strengthened in Canada
-AboutLawsuits
12/22/2008- Health Canada has said that the warning label information about potential Actos heart failure side effects will be strengthened to indicate that the diabetes drug should not be used in patients with pre-existing heart failure or taken together with metformin and a sulfonylurea.
READ MORE::

Diabetes Drugs Must Now Clear Cardiovascular Hurdle, Says FDA
-heartwire
12/19/2008- The Food and Drug Administration is now recommending that all new drugs developed for the treatment of type 2 diabetes show that they do not increase the risk of cardiovascular events.
READ MORE::

Diabetes: Major drugs cause bone loss and fractures
-WDDTY
12/18/2008- The major drugs for treating type II diabetes can cause bone loss and fracture, a new study has discovered. The effects can occur within just a year of taking the drugs.
READ MORE::

Two Diabetes Medications Double Fracture Risks in Women
-HealthNews
12/14/2008- If you have diabetes you might want to ask your physician to review the risks of the medications before taking them. Two widely prescribed medication for diabetes, Actos and Avandia, have both been shown to double the risk of fractures among women. The fracture risk did not increas for men.
READ MORE::

Avandia, Actos May Impact Bone Density In Women
-InjuryBoard
12/10/2008- The widely prescribed diabetes drugs Avandia and Actos have been in the news lately because of concerns about the risk for heart failure. Now a British analysis finds Avandia and Actos double the risk of fractures in women, not in men.
READ MORE::

Diabetes drugs double women's fracture risk
- USA Today
12/09/2008- Long-term use of a popular class of oral diabetes drugs doubles the risk of bone fractures in women with type 2 diabetes, a new study reports.
READ MORE::

GSK diabetes drug to carry risk warning
-TheEconomicTimes
12/04/2008- NEW DELHI: The country's drug quality regulator, Drug Controller General of India (DCGI), has asked companies selling diabetes drug rosiglitazone under various brand names to carry a warning on their labels cautioning against its potential risk to heart patients.
READ MORE::

Safety risks higher with Avandia than Actos -study
-Reuters
11/25/2008- Older diabetics who took GlaxoSmithKline's Avandia to control their blood sugar had a higher risk of death and heart failure while on the drug than those who took Takeda Pharmaceutical's Actos, a drug in the same class, U.S. researchers said on Monday.
READ MORE::

Public Citizen Petitions FDA to Ban Avandia, Cites Life-Threatening Toxicity as Top Diabetes Associations Advise Against Use
- Public Citizen
10/30/2008 - WASHINGTON, D.C. – The Food and Drug Administration (FDA) should immediately ban the dangerous diabetes drug Avandia because it can cause death from liver failure and has many other life-threatening risks that far outweigh its benefits, Public Citizen said in a petition filed today with the agency.
READ MORE::

Avandia – A Slow Killer
-LawyersandSettlements
09/30/2008- Cottage Grove, OR: Robert has lived his whole life without any serious illnesses. And until recently, he considered himself to be a pretty healthy man. Unfortunately, Avandia took that away from him, made him sick, and likely caused the need for triple by-pass surgery.
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Avandia –Two Weeks to Near Death
-LawyersandSettlements
09/18/2008- Canfield, OH: Dennis is just 40 years old. He was diagnosed with type 2 diabetes and was put on Avandia. But after only two weeks on the drug, Dennis experienced shortness of breath and chest pains. He had a heart attack and he thinks Avandia could have been the cause.
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"Avandia Changed My Life Forever"
-LawyersandSettlements
09/17/2008- Pacific Junction, Iowa: Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever.
READ MORE::

Discovered Avandia Problems Just in Time
-LawyersandSettlements
09/11/2008- Donita has type 2 diabetes, and was on Avandia for over seven years. One heart attack and a triple bypass later, her life has changed forever, but she's grateful she discovered potential problems with the drug, and got off it before it was too late.
READ MORE::

FDA to List Drugs Being Investigated
-WashingtonPost.com
09/06/2008- The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.
READ MORE::

Avandia Manufacturers Under Scrutiny From the African American Community
-NewYork Injury News.com
09/03/2008- Avandia has been the subject of widespread speculation that has brought drug manufacturer GlaxoSmithKline under fire for product liability claims. The drug, used to treat Type 2 diabetes, has been linked to cardiovascular deaths and serious health conditions.
READ MORE::

Oral Diabetes Drugs May Make Heart Failure Worse
-About.com:Drugs
09/02/2008- According to researchers at Wake Forest University, a class of oral drugs (the thiazolidinediones), which includes Avandia (rosiglitazone) and Actos (pioglitazone) may make heart failure worse in people with type 2 diabetes.
READ MORE::

Journal calls for Avandia restrictions
-FiercePharma
08/30/2008- In the hardest-hitting assessment of diabetes meds this year, two Wake Forest University researchers say regulators should restrict use of the glitazone class of drugs--which includes the long-suffering Avandia.
READ MORE::

Avandia Class Action Lawsuit Filed in Canada
-AboutLawsuits.com
08/30/2008- A class action lawsuit filed this week against the makers of Avandia and the Canadian government alleges that the popular diabetes drug increases the risk of heart failure, heart attack and death for older users.
READ MORE::

Avandia – A Fast Track to Death
-LawyersandSettlements
08/30/2008- Marina Del Ray, CA: Marla's mother, Vivian, died of heart failure less than a month after starting on Avandia. While Vivian was diabetic, Marla had no indication that her mother could suddenly die of heart failure. But now she wonders if Avandia played a role in her mother's death.
READ MORE::

MEDICATIONS YOUR OWN DOCTOR WON'T TAKE
-InjuryBoard.com
08/27/2008- I found an interesting article from MSN Health & Fitness regarding Eight Drugs Doctors Would Never Take. Most interesting to me was that two of the drugs listed were drugs I've taken in the past and never had any idea I shouldn't have taken them. More importantly -- they are still on the market and you may also be taking them.
READ MORE::

Stroke, Heart Attack, Kidney Failure – Was Avandia to Blame?
-LawyersandSettlements
08/23/2008- Reno, NV: Lisa's father was diabetic and like many diabetics, he had difficulty regulating his blood sugar. So his doctor put him on Avandia to help. He died within 18 months of starting on the drug.
READ MORE::

Warning issued on dangers of diabetes drug Avandia
-News-Medical.net
08/21/2008- Thousands of Australians who are taking the diabetes drug Avandia (rosiglitazone) have been urged by the drug's manufacturer to see their doctors following safety issues concerning the medication.
READ MORE::

Diabetes drug users urged to see doctor
-News.com.au
08/20/2008- MORE than 30,000 Australians taking the controversial diabetes drugs Avandia and Avandamet are being told to have their treatment reviewed after the medications were linked with heart failure and death.
READ MORE::

Avandia: I Nearly Died at 45
-LawyersandSettlements
08/11/2008- Pierrefonds, PQ: Grant has been a diabetic most of his life. Like most diabetics, he's tried several diabetes medications, and eventually Avandia. While the drug did control his blood sugar, it may also have contributed to a diagnosis of congestive heart failure, a ruptured aorta, and atrial fibrillation.
READ MORE::

Avandia Data Withheld from the FDA
-InjuryBoard.com
08/07/2008- Avandia drug manufacturer, GlaxoSmithKline, failed to disclose several studies about Avandia to the FDA. Earlier this year, the FDA issued a warning letter to GlaxoSmithKline for postmarketing safety reporting failures.
READ MORE::

Avandia- the Drug that Keeps on Giving
-LawyersandSettlements
07/28/2008- Charlotte N.C.: Vanessa is just 37 years old and diabetic. She is also someone who has survived several months on Avandia, but like many others, suffered avandia-related shortness of breath, swelling, liver problems. Luckily, she lived to tell about it.
READ MORE::

Avandia Study Shows 60 Percent Increase in Heart Failure Risk Among Diabetics who Take the Drug
-Natural News

07/28/2008- Seniors who take the popular Type 2 diabetes drug Avandia have a 60 percent higher risk of heart failure than patients who take other diabetes medications.
READ MORE::

Diabetes Drug Avandia Causes Brittle Bones, Researchers Declare
-Natural News
07/26/2008- The widely used diabetes drug rosiglitazone, marketed as Avandia, may increase the risk of brittle bones and osteoporosis, according to a new study conducted by researchers from the Salk Institute in La Jolla, California, and published in the journal Nature Medicine.
READ MORE::

Avandia: Back from the Brink
-LawyersandSettlements.com
07/24/2008- As a result of events in 2007, Jack has been forced to face the prospect of early retirement, and must live a fairly stress-free life. In the Spring of that year he suffered a heart attack then heart failure, while he was taking Avandia. Could Avandia have contributed?
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Avandia: Dead at 39
-Lawyers and Settlements
07/15/2008- Charles' wife had diabetes, and she had been taking Avandia as prescribed by her doctor. But it didn't do her any good. She died at the age of 39, after having experienced a series of heart problems and resulting surgeries.
READ MORE::

FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
-CNN

07/14/2008- GlaxoSmithKline (NYSE: GSK) announces today that the U.S. Food and Drug Administration (FDA) updated the prescribing information for AVANDIA(R) (rosiglitazone maleate) to include clinical findings from A Diabetes Outcome Progression Trial.
READ MORE::

Should the FDA Require Cardiovascular Studies for Diabetes Medications?
-About.com

07/10/2008- The FDA is considering the possibility that required cardiovascular studies should be added to the approval process for diabetes drugs. There does seem to be a correlation between cardiovascular risks and diabetes medications.
READ MORE::

07/08/2008- Two North Carolina patients have sued GlaxoSmithKline, claiming that the drug maker's diabetes pill, Avandia, caused their heart attacks.
READ MORE::

-FDA News
07/03/2008- Clinical trial designs for diabetes drugs are not good enough at detecting cardiovascular risk with GlaxoSmithKline’s (GSK) Avandia being Exhibit A, according to experts at a Tuesday meeting of CDER’s Endocrinologic and Metabolic Drugs Advisory Committee.
READ MORE::

A Year and a Half on Avandia Resulted in Heart Failure
-Lawyers and Settlements
06/26/2008- James had been on Avandia for about a year and a half when he began to notice swelling in his ankles and shortness of breath. Just a few months ago he went from having possible respiratory problems to confirmed heart failure in the space of a week.
READ MORE::

Ketek, Avandia Among Drugs Doctors Won’t Take
-NewsInferno
06/23/2008- When doctors were recently asked which commonly prescribed medications they would avoid, they came up with the following eight. Perhaps you might want to reconsider these medications as well. At a minimum, speak to your doctor, as there are safer options for all of these medications.
READ MORE::

Near Death Experience on Avandia
-Lawyers and Settlements
06/13/2008- Otis is a coach and teacher at a high school in Texas. He was put on Avandia for his diabetes approximately five years ago. In the fall of 2006 he was hospitalized for a heart attack, possibly an Avandia heart attack. At the time he was unaware of the problems with avandia--but that was about to change.
READ MORE::

ADA: VA Trial Assertion on Rosiglitazone (Avandia) Heart Safety Called Problematic
-MedPage Today
06/11/2008- The VA Diabetes Trial analysis that showed no extra cardiovascular risk from rosiglitazone (Avandia) should not be taken as conclusive, cautioned independent investigators and statisticians.
READ MORE::

GSK: Money-Green Outside, Pink-Slip Inside
-FDA News
06/11/2008- In his blog, Derek Lowe considers possible reasons for GlaxoSmithKline’s major cuts in its research staff.
READ MORE::

Avandia: Sales of Diabetic Drug Gutted in Wake of Concern
-Lawyers and Settlements
06/06/2008- When the American Diabetes Association convenes here June 6th for their annual meeting, there is little doubt that amongst the topics up for discussion will be the fall of Avandia.
READ MORE::

Six Years of Avandia and Two Heart Attacks Later
-Lawyers and Settlements
05/30/2008- March 1st, 2007 was a day Larry remembers well because he walked into hospital while having a heart attack--his second within 24 hours. He didn’t know he was having a heart attack, and it was the last thing he expected, because he had been taking Avandia for six years.
READ MORE::

Avandia Heart Attack
-Lawyers and Settlements
05/16/2008- New Orleans, LA: After being on Avandia for two years, Gail suffered a heart attack. When she was admitted to hospital, immediately following her heart attack, the doctors did an angiogram and found that all the arteries were blocked. Gail had to have five stents put in, which required two separate operations.
READ MORE::

Legal View Reports on Details of FDA Warning to Avandia Manufacturer For Witholding Information
-TransWorldNews
05/05/2008- Denver, CO LegalView.com, the number one resource for everything legal on the Internet, published news of the most recent Avandia update specifying the U.S. Food and Drug Administration (FDA)'s warnings to GlaxoSmithKline, makers of the type 2 diabetes drug Avandia. The warning resulted from the manufacturer's noncompliance with reporting post-marketing research information on the drug. The company did not issue the full breadth of research for 10 ongoing clinical trials that spanned from 2001 to 2007.
READ MORE::

Avandia One Year Later
-Lawyers and Settlements
05/04/2008- Atlanta, GA: A new report suggests that doctors are continuing to be increasingly concerned with regard to the safety and efficacy of Avandia, with that concern increasing nine-fold since the once-popular GlaxoSmithKline diabetes drug blasted into the headlines last spring.
READ MORE::

04/24/2008- GlaxoSmithKline, the world's No 2 pharmaceuticals firm, announced disappointing first-quarter results yesterday, with profits down on the same period last year, as sales of Avandia continued to fall.
READ MORE::

-PRNewswire

04/22/2008- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the percentage of primary care physicians (PCPs) and endocrinologists who consider the cardiovascular safety of GlaxoSmithKline's Avandia to be a major concern increased more than nine-fold following publication of a meta-analysis.
READ MORE::

FDA: Glaxo withheld Avandia studies
Bloomberg News
04/17/2008-GlaxoSmithKline PLC, Europe's largest drugmaker, failed to properly disclose studies of Avandia, the diabetes pill linked to potentially deadly side effects, U.S. regulators said.
READ MORE::

-Medical News Today
04/14/2008- GlaxoSmithKline confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year.
READ MORE::

-PharmaTimes
04/14/2008- The two licensed glitazone antidiabetics, pioglitazone (Actos, Takeda) and rosiglitazone (Avandia, GlaxoSmithKline), now account for more than 50% of expenditure on oral hypoglycaemic drugs in the UK’s National Health Service (NHS).
READ MORE::

-Motley Fool

04/11/2008- Every large-cap pharma seems to have at least one marketed drug that produces endless streams of woe for them. In GlaxoSmithKline's (NYSE: GSK) case, the drug in question is its type 2 diabetes compound, Avandia.
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-FDA News
04/10/2008- When GlaxoSmithKline’s (GSK) incoming CEO Andrew Witty takes the helm next month, he will have to deal with fallout from drug safety concerns surrounding Avandia, which have expanded to include a new FDA warning letter.
READ MORE::

GSK rebuked for missing Avandia reports

-Fierce Pharma

04/10/2008- GlaxoSmithKline got a trip to the FDA woodshed for failing to regularly report post-marketing data it was gathering on the diabetes med Avandia. GSK failed to include updates on as many as 18 different trials in its annual reports to the agency on that med. The agency rebuked GSK, ordering the company to get its act together pronto.
READ MORE::

Glaxo Failed to Disclose Avandia Studies, FDA Says

-Bloomberg

04/08/2008- GlaxoSmithKline Plc, Europe's largest drugmaker, failed to properly disclose studies of the diabetes pill Avandia after it was linked to potentially deadly side effects, U.S. regulators said.
READ MORE::

FDA says Glaxo failed to report Avandia data

-Reuters
04/08/2008- GlaxoSmithKline Plc failed to report some post-marketing data on its diabetes drug Avandia, the U.S. Food and Drug Administration said in a warning to the company released on Tuesday.
READ MORE::

GlaxoSmithKline receives FDA warning letter on regulatory reporting

-CNN
04/08/2008- GlaxoSmithKline (NYSE:GSK) Plc., said it has received a warning letter from the Food and Drug Administration, which points to failures in periodic reports to the agency about its troubled Avandia diabetes product.
READ MORE::

-The Scotsman

04/07/2008- SCOTTISH doctors have said there is "no defence" for the use of a widely prescribed diabetes drug after warnings that it should not be used in patients with heart problems, The Scotsman can reveal.
READ MORE::

New Guidelines, Safety Issues Reshape
Diabetes Space
03/29/2008- The diabetes landscape is a tad riskier for drugs in development that have a safety glitch or two, and the bottom line could mean higher costs.
New FDA draft guidance calls for more patients and lengthier trials for companies with certain safety issues, but the rules are no different from what is expected in drug development for other chronic conditions, the agency has said.
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Diabetics in limbo over conflicting blood sugar studies
-Forbes

03/16/2008 - Donald McEwen was driving on I-480 when he saw an ad on the back of a bus recruiting people for a study on diabetes.
READ MORE::

FDA's review process under investigation

-Forbes

03/04/2008 - The government's watchdog agency is investigating whether the Food and Drug Administration's drug-review process cleared two blockbuster medications without sufficient proof of their safety or effectiveness.
READ MORE::

FDA Ponders Stricter Rules For Diabetes Drugs
-Forbes
03/04/2008 - In the wake of the controversy over the diabetes drug Avandia, the U.S. Food and Drug Administration is considering tougher standards for how and when diabetes drugs will be tested for risks to the heart.
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Consumers tune out FDA warnings
-CNN
02/25/2008 - A flood of drug safety warnings from the Food and Drug Administration may have physicians and patients suffocating from information saturation. Experts say there are too many red flags for them to pay attention.

"It seems that almost weekly we're getting a safety missive," said Les Funtleyder, an analyst who covers the pharmaceutical industry for trading firm Miller Tabak. "We're almost getting safety fatigue."
READ MORE::

Medication Under a Microscope
-Washington Post
02/19/2008 - A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's
leading health problems.
READ MORE::

Diabetes drug and conflicts of interest
-Science Daily
02/04/2008 - So much for confidential peer review.
Last May, a controversial paper in the New England Journal of Medicine (NEJM) reported that a popular diabetes drug—rosiglitazone, sold under the brand name Avandia—substantially hikes a user's risk of heart attack.
READ MORE::

New England Journal reviewer tipped drug firm, Nature reports
- Boston Globe
01/31/2008 -  A peer reviewer for the Waltham-based New England Journal of Medicine leaked a negative article about a diabetes drug to its manufacturer more that two weeks before the study appeared, another major scientific journal reports today.
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Article on Avandia Study Was Leaked to Glaxo
- Wall Street Journal

01/31/2008 -  Weeks before an influential article was published last year in the New England Journal of Medicine linking the diabetes drug Avandia to a risk of heart attacks, a physician helping peer-review the article broke the Journal's confidentiality rules and leaked a copy to the drug's maker, GlaxoSmithKline PLC.
READ MORE::

Reviewer leaked Avandia study to drug firm
- Nature
01/30/2008 -  A peer reviewer for The New England Journal of Medicine (NEJM ) broke confidentiality and leaked a damaging report about the blockbuster diabetes drug Avandia to the drug's manufacturer weeks ahead of publication, Nature has learned.
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Avandia Study Results Were Leaked Early to Glaxo
- CNBC
01/30/2008 -  The wall between a prestigious medical journal and a major drug company may have been shattered.
READ MORE::

FDA Procedures Draw Scrutiny
- Wall Street Journal
01/25/2008 -  Controversies about cholesterol drug Vytorin and diabetes drug Avandia are reigniting debate over what evidence the Food and Drug Administration requires to approve drugs -- and may generate pressure on the agency to raise its bar.
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GlaxoSmithKline to revise labeling for Avandia after EU regulator's decision
- CNN
01/24/2008 -  GlaxoSmithKline (NYSE:GSK) PLC said is to revise the labeling on its Avandia diabetes product to include additional warnings that the product may be associated with an increased risk of heart attacks, after a decision by the European regulator (CHMP) today.
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Avandia, human genome among the things we've learned from in the past year

-USA Today
12/23/2007 - Persistent questions about the safety of both prescription and over-the-counter drugs, a menacing microbe spreading throughout the U.S. and a globe-trotting TB patient garnered headlines this past year. A look back at the top health stories of 2007.
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Under no circumstances should you discontinue taking any medication, including Avandia, without first consulting with your doctor.

If you or a loved one have experienced an Avandia Heart Attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Avandia's side effects, a possible Avandia class action lawsuit, or any other type of Avandia litigation. Call us toll-free at: 1.800.856.6405 or fill out the free case evaluation form on this page.

Avandia Side Effects Lawsuit