Ennis & Ennis News Archive News Archive
 
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Chantix linked to depression

-ABC News

05/09/2008 - A popular drug used to help people quit smoking is now being linked to depression and suicidal behavior. More>>>

Chantix Helps Smoking Stoppage, May Lead to Suicide

-eNews 2.0

05/09/2008 - The federal government suggests doctors should recommend Chantix to patients who are to quit smoking. Chantix is a drug released by Pfizer Inc. in 2006 and is considered to have the highest efficiency in combating this vice. The issue is that, despite the praise about its proficiency, its side effects are worrisome. More>>>

Trasylol: "I've Gone Through Hell"

-Lawyers and Settlements
05/09/2008 -
Loretta M. says she is sure she was given Trasylol during her open heart surgeries because her doctor spoke about using blood-regulating drugs during surgery. More>>>

Ortho Evra: Convenience at a Terrible Cost

-Lawyers and Settlements

05/09/2008- She was just 18 when the Ortho Evra patch claimed her life. A student, studying for a career in fashion. After she collapsed in a Manhattan subway in April 2005 and subsequently died, an autopsy revealed that a blood clot had formed and moved into the young lady's lung. More>>>

Baxter: under fire over contaminated heparin

-Pharmaceutical Business Review

05/08/2008 - In the latest development of the long drawn out heparin saga, Jin Shaohong, China's Deputy Director of the National Institute for the Control of Pharmaceutical and Biological Products, maintains that contamination, in the form of over-sulphated chondroitin sulphate (OSCS), cannot be irrefutably linked to up to 81 deaths and numerous cases of severe allergic reactions in the US. More>>>

US group wants FDA to pull J&J birth control patch

-Reuters

05/08/2008- A U.S. advocacy group is urging the Food and Drug Administration to pull Johnson & Johnson's birth control patch from the market after studies found an increased risk of dangerous blood clots. More>>>

Seabrook family wakes up to truck explosion
- Bay Area Citizen
05/07/2008- It’s a situation all parents hope they’ll never have to contemplate - which kid to save from death first. Christi Ault’s eyes fill with tears as she thinks about how close she came to that situation last Sunday, when her Ford F-150 truck spontaneously exploded into flames only an hour and a half before her three children would have been strapped into their car seats. More>>>

The mystery of medications linked to suicide
-MSNBC
05/07/2008- When Kate Miller of Queensbury, N.Y., filled a new allergy drug prescription for her 15-year-old son, Cody, last July, she hoped it would improve his bothersome allergy symptoms. Now, Miller is wondering whether a possible side effect of the drug, Singulair, caused Cody — who she describes as a happy, athletic teenager — to take his own life about a month later. More>>>

Pfizer relaunches ads for smoking cessation drug Chantix

- Star Ledger

05/07/2008 - Pfizer yanked ads for its smoking cessation drug Chantix earlier this year because of safety concerns -- specifically, reports that taking the drug could lead to behavioral changes, depression and even suicidal thoughts in some patients. More>>>

Ortho Evra Patch: Silence Is Not the Answer

-Lawyers and Settlements

05/07/2008- Currently, more than 3,000 women and their families in the United States are suing Johnson and Johnson, the makers of the Ortho Evra birth control patch, because they have suffered life threatening adverse health effects such as blood clots, heart attacks, and stroke, as a result of using this controversial form of birth control. Some 40 women have died while using it. More>>>

A Warning About NuvaRing
-InjuryBoard

05/06/2008- A woman has suffered blood clots caused by NuvaRing, a transparent vaginal ring that provides month long birth control. The ring releases a continuous, low dose of estrogen and progestin for 21 days. Since NuvaRing hit the market seven years ago, it has been the subject of hundreds of lawsuits related to blood clots. Twelve deaths across the nation have been attributed to NuvaRing. More>>>

China says Baxter holding up heparin investigation
-Reuters

05/06/2008 - Chinese officials said on Tuesday a Chinese-made blood thinner was not to blame for fatalities linked to the product, and accused U.S. drugmaker Baxter International Inc of obstructing the investigation into the cause of the problem. More>>>

Trasylol: Bayer Bracing for Lawsuits

-Lawyers and Settlements
05/06/2008 -
As Bayer AG continues to study the results of the Canadian BART trial on Trasylol, and whether or not those findings may compel the manufacturer to lobby health regulators as to the merits of re-marketing a now-vilified drug, its legal arm prepares for its day in court as lawsuits against Bayer mount. More>>>

NuvaRing Suspected in Mother's Death
-Lawyers and Settlements

05/05/2008- She was young, healthy and fit; a runner and a vibrant mother of two. So it was a complete shock when, one morning in February of 2006, 31-year-old Rosana Mariconda collapsed onto her bed while getting ready for work. She died of a stroke, and her husband Frank suspects the NuvaRing birth control device she was using. More>>>

LegalView Reports on Details of FDA Warning to Avandia Manufacturer for Withholding
-TransWorldNews
05/05/2008- 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. More>>>

Osteoporosis Drug Can Flutter the Heart
-Heartzine
05/05/2008- The osteoporosis drug Fosamax that is prescribed to women might increase their risk of developing an irregular heart beat, a study by researchers at the Group Health Centre for Health Studies and University of Washington suggests. Despite the findings, the researchers conclude that the benefits of the drug far outweigh the risks faced by women. More>>>

MRI Health Risk: “Doctors Said the Dye caused Kidney Failure”
-Lawyers and Settlements
05/05/2008- Eighteen months ago, Norm C. was very healthy and active. But he took a turn for the worse and ended up in hospital where he was injected with a gadolinium based contrast agent (like a dye) and had an MRI to determine what was wrong. Turns out, the dye just about killed him. More>>>

Trasylol Death Unnecessary
-Lawyers and Settlements
05/04/2008- Although Trasylol has been recalled, many people are only now realizing that they or their loved ones may have been given the drug during open heart surgery and may have suffered serious adverse reactions to the drug, including kidney failure. More>>>

Fosamax “Dead Jaw Syndrome” Tied to Microbial Biofilms
-NewsInferno
05/04/2008- Microbial biofilms are behind a nasty side effect of osteoporosis drugs like Fosamax, new research says. These biofilms, a mix of bacteria and sticky extracellular material, are causing jaw tissue infections in patients taking bisphosphonate drugs like Fosamax, Actonel and Boniva, according to a study conducted at the USC School of Dentistry. Earlier this year, another group of researchers linked biofilms to eye infections that were caused by recalled Renu with MoistureLoc Contact Lens solution in 2006. More>>>

Accutane News – Case 1, 2 and 3 - $7m, $2.6m and now $10.5m
-Lawyers and Settlements
05/04/2008- Accutane is a drug for treating severe acne. There are important and significant side-effects disclosed on the written warning. One side effect caused by ingesting Accutane is ulcerative colitis. A New Jersey state court jury awarded a 24 year old woman $10.5 million for compensatory damages. They Court did not allow the jury to consider punitive damages or consumer fraud issues. More>>>

Avandia One Year Later
-Lawyers and Settlements
05/04/2008- 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. More>>>

Eli Lilly STALLING on ZYPREXA Payout
-World Forum

05/02/2008 - Lilly's credibility over their continuous PR on how they are going to pay out $1.2 billion in Zyprexa damages Many claimants are being stonewalled. More>>>

Stryker’s Quality Control Effort to Cost Millions
-FDA News
05/02/2008 -  As Stryker’s hip implant franchise took a $15 million to $20 million hit last quarter due to a recall and temporary production stoppage of its implantable hip cups, the company is spending millions of dollars instituting a corporatewide quality control program meant to resolve two FDA warning letters. More>>>

Chantix Caused Veteran’s Depression

- Lawyers and Settlements

05/01/2008 - When John came back from Kuwait a few months ago, his VA doctor said that Chantixwas the 'Number 1' drug to quit smoking. He neglected to tell John of the side effects, such as depression and suicidal thoughts. More>>>

1st suspected victim of Ortho Evra reported in Taiwan

-The China Post

04/30/2008 - The controversial Ortho Evra birth control patch, marketed in Taiwan as the Evra Transdermal Patch, may have claimed its first victim on the island. More>>>

Heparin Contamination May Have Been Deliberate, F.D.A. Says

-NY Times

04/30/2008 - Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously. More>>>

Congressman: ‘Citizens Can No Longer Trust’ FDA

-Wall Street Journal

04/30/2008 - The FDA got another tongue lashing from Rep. John Dingell yesterday, who seems frustrated that the agency isn’t clamoring for more money to inspect foreign manufacturing plants. More>>>

Researchers Uncover Link Between Osteoporosis Drugs and Jaw Infection

-Health News Digest

04/30/2008 - A group of University of Southern California School of Dentistry researchers says it has identified the slimy culprits killing the jawbones of some people taking drugs that treat osteoporosis. More>>>

Baxter CEO: Heparin contamination was deliberate

-Reuters

04/29/2008 -  The contamination of Baxter International Inc's blood-thinner heparin appears to have been deliberate, the company's chief executive said in testimony prepared for a congressional hearing on Tuesday. More>>>

Families, CEOs to testify on tainted heparin in US

-Reuters

04/29/2008 -  People who lost relatives to deadly reactions from the blood-thinner heparin are set to testify on Tuesday before U.S. lawmakers probing contamination of the drug made with raw ingredients imported from China. More>>>

Trasylol May Have Caused Advanced Kidney Failure

-Lawyers and Settlements
04/29/2008 - Mark L. suffered kidney failure shortly after his open heart surgery. However, he does not know for sure if Trasylol was used. Mark is now trying to determine whether or not doctors gave him Trasylol to stop him from bleeding during surgery. More>>>

Medical School Group Urges Freebie Ban

-FDA News
04/28/2008 - Drug and device makers shouldn’t be allowed to offer freebies - including meals, gifts, travel and ghost-writing helps - to docs, staffers and students in any or all 129 of the nation’s medical colleges, according to a new report from the Association of American Medical Colleges, which spents two years on the project. More>>>

Anti-addiction drugs linked to depression

-Daily Times

04/28/2008 - Pills that aimed to help people quit smoking, lose weight and kick other tough addictions, have been found to block the body’s pleasure centres, possibly raising the risk of depression and suicide. More>>>

Woodcock to Congress: Industry Must Be Held Responsible for Drug Quality

-FDA News

04/28/2008 - With the FDA under fire from lawmakers over its apparent inability to regulate the quality of imported products, CDER Director Janet Woodcock told a Senate panel Thursday that companies need to be held accountable for the quality of their drugs and active pharmaceutical ingredients (API). More>>>

The Frightening Heparin Case

-NY Times

04/28/2008 - The story of a deadly, contaminated blood thinner has laid bare serious deficiencies in the regulatory oversight of drugs imported from China and other developing countries. More>>>

MRI Side-effects: The Hard Facts on NSF/NFD

-Lawyers and Settlements

4/27/2008 - Having a Magnetic Resonance Imaging (MRI) scan using the contrasting agent gadolinium during the procedure may induce the onset of a debilitating malady commonly known as NSF/NFD. More>>>

Pharma "must take more responsibility for quality:" FDA

-PharmaTimes

04/27/2008 - The US Food and Drug Administration will never have sufficient resources to be “the quality-control unit of the world,” and drugmakers will have to assume more responsibility for the quality of their products, a senior agency official has told US legislators. More>>>

My Bones Ache And Pop, But Is My Hip Implant Supposed To Squeak?
-Injury Board
4/27/2008 - Hip implant surgery sounds like a terribly, painful process, but I have been told that the relief of chronic pain makes the surgery worthwhile.  But now many hip implant folks are noticing that their joints are squeaking.  Sometimes doctors tell them that this is something that they must endure. But now we know that the squeaking is the result of a defective implant. More>>>

Teen critically injured when ATV flips over in field

- Enid News, OK

04/27/2008 - An Enid teen was critically injured Saturday when an all-terrain vehicle flipped and threw him off. More>>>

Two firefighters dead in ATV accident

- Mail Tribune

04/26/2008 - Medford firefighters Gale Gurr and John Wells worked together, played together, and their families even vacationed together. On Thursday, the two were riding together in the Johns Peak area on a new Polaris Ranger RZR when the all-terrain vehicle designed for two riders to sit side by side tumbled down a steep slope they were climbing and hit a tree, Jackson County Sheriff Mike Winters said. Gurr, 37, and Wells, 51, both died. More>>>

FDA-approved Lawsuit Preemption
planetc1.com-news
04/26/2008-Everyone seems to be picking on the poor Food and Drug Administration (FDA) these days, but for vastly different reasons. To the hundreds of thousands of victims (including dead ones) of adverse prescription drug reactions each year, and their families, the FDA is failing to protect the public. More>>>

Ford Explorer Blamed For House Fire Days After Recall Issued
digtriad.com
04/26/2008- Investigators say a 1998 Ford Explorer was to blame for a house fire in Raleigh early Thursday, less than 48 hours after Ford had issued a recall notice for 9.6 million cars and trucks. More>>>

Ennis & Ennis, P.A. Announces Today: Still Accepting Accutane Case
-openpress
04/26/2008- The Law Offices of Ennis & Ennis, P.A. congratulates attorney Mike Hook and his team for their $10.5 million dollar verdict in a New Jersey state court for a 24 year old woman who was diagnosed with ulcerative colitis after using the acne medication Accutane. Attorney David F. Ennis stated: "We have been fighting with Mike and his team since 2003 and it is refreshing to see these stories are coming to light. Our only concern is there are many more victims out there who have not been advised of their legal rights. More>>>

Yamaha Motor Corporation U.S.A. recalls Rhino side-by-side vehicles
-WTOL
-04/26/2008- The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed. More>>>

Bayer CEO says faces 78 Trasylol lawsuits in U.S
Reuters
04/25/2008 - Germany's Bayer AG is facing 78 lawsuits in the United States linked to its Trasylol drug used to stem bleeding during open heart surgery, its chief executive said on Friday. More>>>

How Tainted Heparin Slipped Through U.S. Safety Net

- MedPage Today

04/25/2008 -- Researchers here revealed today how the adulterated heparin from China evaded detection at the U.S. border and how it killed scores of patients. More>>>

Impurities found in Sanofi heparin product

-Fierce Pharma

04/25/2008 -- While heparin maker Baxter mulls whether to re-enter the market for that blood thinner, Sanofi-Aventis is announcing that small amounts of an impurity have been found in batches of its heparin injection Lovenox. More>>>

Researchers Agree With FDA, Confirm Heparin Contaminant

- dbtechno.com

04/25/2008 -- Researchers in the U.S. have come out and stated that they have found a chemical contaminant in the blood-thinner heparin. The contaminant found in the heparin, which came from China, has been proven to be potentially deadly. More>>>

Alert issued over heparin injection impurity

-Nursing Times

04/25/2008 -- Nurses are being warned to look out for adverse drug reactions (ADRs) after some batches of a heparin injection drug were found to contain impurities. More>>>

The Hell of Chantix: In Their Own Words

-Lawyers and Settlements

04/24/2008 - There is nothing more compelling than someone's own story, and the stories involving Chantix and its Canadian and European counterpart Chantix, abound. More>>>

Researchers Identify Contaminant in Tainted Heparin

-Washington Post

04/24/2008 -- U.S. researchers say they've confirmed that lots of the blood thinner heparin pulled from the market are contaminated with a man-made chemical called oversulfated chondroitin sulfate. More>>>

Avandia fears knock hole in GSK's profits

-The Independent

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. More>>>

Jury Awards Woman $10.5 Million In Accutane Suit
- Wall Street Journal
04/23/2008- A New Jersey state-court jury awarded a 24-year-old woman $10.5 million in a case involving acne medication Accutane, one of 425 cases against Hoffmann-LaRoche Inc. alleging that the drug causes inflammatory-bowel disease. More>>>

What You Need To Know About Heparin

-Campus Progress

04/23/2008 -- It’s been linked to the death of dozens, and it’s leading to a clash between researchers and policy makers in America and China. But… what is it? More>>>

House Panel Criticizes F.D.A. Role in Drug Cases

-NY Times

04/23/2008 -- House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products. More>>>

FDA commissioner grilled on drug oversight lapses

-Chicago Tribune

04/23/2008 -- With dozens of people dead after receiving infusions of the contaminated blood thinner heparin, the head of the Food and Drug Administration faced withering scrutiny from a congressional subcommittee. More>>>

FDA IDs Link Between Heparin Contaminant, Adverse Reactions

-FDA News

04/23/2008 -- FDA data show a “solid mechanistic link” between a heparin-like contaminant originating in China and serious adverse events and deaths, CDER Director Janet Woodcock said. More>>>

Drug-Coated Stent Fit for the Long Haul?

-WebMD
04/23/2008 - The new Xience stent beat the popular Taxus stent in a one-year trial, but experts disagree on whether stent science is moving too fast. More>>>

Lawsuits seek damages from Bayer over anti-bleeding drug

-Miami Herald
04/23/2008 - Eight lawsuits filed in a Florida federal court are seeking damages from Bayer AG over a controversial anti-bleeding drug. More>>>

Yamaha Rhino Rollover: Lawsuits Still Being Filed

- Lawyers and Settlements

04/23/2008 - Lawsuits are still being filed alleging the Yamaha Rhino ATV is defectively designed, rolls over too easily and lacks proper safety equipment. Plaintiffs say they have suffered permanent injuries and faced numerous surgeries as a result of their accidents. As more people realize that their Yamaha Rhino rollover may not have been their fault, more lawsuits will likely be filed. More>>>

Kikkan Randall on the mend after 2nd hospital stay

-SkiRacing

04/22/2008 - Right now, the woman who blazed down a trail in Russia last season to set a new standard in American cross-country ski racing can’t walk without a limp. More>>>

Univ. of Cincinnati Psychiatrist Under More Scrutiny Over Funding
-Wall Street Journal
04/22/2008 - An academic psychiatrist whose ties to AstraZeneca got called out by a U.S. senator a couple of weeks ago is getting a more scrutiny from her university. More>>>

Death Toll Due to Tainted Heparin in US Rises to 81
-OpEd News

04/22/2008 -- Federal officials in the US now say that the death toll due to adverse reactions to contaminated heparin coming from China has risen to 81, whereas Chinese officials dispute that any deaths were caused by the contaminant. More>>>

U.S. Identifies Tainted Heparin in 11 Countries
-NY Times

04/22/2008 -- A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States. More>>>

US regulator not amused by Viva Viagra! online ad

-PharmaTimes

04/22/2008 - US regulators have sent a warning letter to Pfizer about a promotional video for Viagra which failed to point out the risks involved in taking the erectile dysfunction blockbuster. More>>>

Ortho Evra Patch Makers Settling Cases

-PRNewswire

04/22/2008 - Evidence shows that Ortho Evra is dangerous and should be recalled from the market. Studies found that women using the Ortho Evra birth control patch were twice as likely to develop blood clots compared with those using oral birth control pills. More>>>

Concern From Doctors Regarding the Cardiovascular Safety of GlaxoSmithKline's Avandia Increases Nine-Fold Following Publication of Meta-Analysis

-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. More>>>

China: Bad Heparin Wasn’t Our Fault

-Pharmalot

04/21/2008 -- And so the new cooperation pact with the US Health and Human Services and the FDA begins with a disagreement - Chinese officials are voicing doubts that a contaminant identified in Heparin was the root cause of 81 deaths and severe allergic reactions in hundreds of Americans, the Associated Press reports. More>>>

China Says Contaminant Didn't Cause Heparin Reactions

-Bloomberg

04/21/2008 -- A contaminant in the blood-thinner heparin that was identified last month by U.S. regulators wasn't responsible for causing allergic reactions and deaths, a Chinese regulator said. More>>>

China says chemical not source of heparin woes

-Reuters

04/21/2008 -- A Chinese investigation concluded that a contaminant found in the blood thinner heparin was not the cause of deaths and allergic reactions related to the drug in the United States, a Chinese health official said on Monday. More>>>

Four More Contaminated Heparin Lawsuits being Filed in Toledo

-Lawyers and Settlements

04/20/2008 -- Four more people are filing lawsuits in the Toledo, Ohio area against Baxter Healthcare, the maker of the drug heparin, stating that the drug was contaminated when it was given to their family members. More>>>

Anti-Psychotic Drugs (Zyprexa) Change Metabolism

-American Psysiological Society

04/20/2008 - “Based on these findings we concluded that male rats treated with olanzapine experienced an early disruption of energy metabolism. More>>>

Popular Impotence Drugs May Cause Sudden Deafness

-Natrual News

04/20/2008 - The FDA has announced an immediate change to the labeling of drugs in a family that includes popular impotence drugs, warning that they may lead to sudden, severe and potentially permanent hearing loss. More>>>

Heart Drug Trasylol Pulled From Market After 50 Percent Increase in Death Rate Discovered

-Natural News
04/20/2008 - Pharmaceutical giant Bayer AG has announced that it is withdrawing its drug Trasylol from the market in response to a request by the FDA, in the face of increasing evidence that the drug increases patients' risk of death. More>>>

Fires in old models prompt a total recall by Ford
-NYTimes
04/20/2008- After six recalls to correct problems with millions of Ford Motor Company cruise-control switches blamed for almost 1,500 fires, the National Highway Traffic Safety Administration of the US took an unusual step. In February, it issued a consumer advisory urging owners whose vehicles had not yet been fixed to have the switches disconnected immediately. More>>>

Tainted Heparin Discussed By U.S., Other Countries, FDA Says
-Bloomberg
04/20/2008- The U.S. hosted a meeting of international regulators that ended today on the blood-thinner heparin, a drug linked to allergic reactions and deaths. More>>>

Questions about Trasylol Since 1963
-Lawyers and Settlements
04/20/2008- Cologne, Germany: When Bayer AG convenes its annual stockholder's meeting on April 25th in Cologne, the German group Coalition against BAYER Dangers (CBG) will be on hand to introduce countermotions to the proceedings, one of which will focus on the history, and dangers of Trasylol (known as Aprotinin). More>>>

Merck downplayed death risk of Vioxx
-Reuters
04/20/2008- A new study suggests that drug maker Merck manipulated data about the drug Vioxx. The drug's 2004 recall was the largest in history. More>>>

Woman sues distributor for injuries in ATV accident

- WV Record

04/18/2008 - An ATV distributor is being sued by a woman who was injured when her ATV rolled over, crushing her right hand. More>>>

Anti-smoking drug has ties to serious mental illness

-The Daily Telegram

04/18/2008 - Melinda and Kenny Peterson wanted to kick their two-pack-a-day smoking habit. In early January, the Green Bay couple started taking three-month prescriptions of Chantix, a new anti-smoking pill. About six weeks later, they weren’t smoking at all. More>>>

Heparin case awakens feelings of anger, fear
-ToledoBlade.com

04/18/2008 -  Dennis Staples was planning his 60th birthday party - an affair that kept his spirits high even as his body was struggling with the effects of diabetes and kidney disease. More>>>

Consumer watch — Johnson & Johnson and the FDA

-SeacoastOnline

04/17/2008 - What's worse than breast tenderness and nausea in the female effort to prevent pregnancy? Heart attack, stroke or death. Quitting this week is going to consider the everyday erosions of our medical liberties by the political and economic culture at large. More>>>

Watson recalls single lot of fentanyl patches
-Reuters

04/17/2008- Watson Pharmaceuticals has recalled one lot, or about 28,000 units, of its fentanyl pain patch after ingredient levels were found to have deviated from specifications, a company spokeswoman said on Friday. More>>>

Man Kills Self While Taking Anti-Smoking Drug

-Fox News

04/17/2008 - Omer Jama, 39, of Bolton, England, was a Sky Sports video editor who was taking the drug to try and kick his pack-a-day habit, the U.K.'s Daily Mail reports. 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. More>>>

Articles: Merck Hid Vioxx Mortality Data and Ghostwrote Scientific Articles
-FDA News

4/17/2008 - Merck is denouncing two articles in the current issue of the Journal of the American Medical Association (JAMA) that conclude the company withheld mortality data on its painkiller Vioxx before its approval and that Merck employees guest-authored and ghostwrote medical literature for the drug. More>>>

Heparin Contaminant May Have Been Added to Boost Profits: FDA

-US News & World Report

04/16/2008 -  Batches of Baxter International Inc.'s blood thinner heparin may have been intentionally contaminated to increase profit, U.S. Food and Drug Administration Commissioner Dr. Andrew von Eschenbach suggested at a Senate hearing Tuesday. More>>>

FDA fears heparin tainted on purpose

-Boston Globe

04/16/2008 -  US regulators suspect that Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was intentionally contaminated to increase profit. More>>>

Relying 'Solely' On FDA To Judge Safety Of Ortho Evra Patch Is A Mistake, Editorial Says

- Medical NewsToday

04/16/2008 - It would be a mistake to "rely solely" on FDA to judge the safety and efficacy of the birth control patch Ortho Evra, a New York Times editorial says.More>>>

Vital Vioxx Details 'Manipulated'

-WebMD

4/15/2008 - Two studies appearing in Tuesday's Journal of the American Medical Association have prompted the journal's editors to call for "drastic action" to prevent drug companies from misrepresenting data from clinical trials. More>>>

FDA sees economic motive for tainted heparin
-Reuters

04/15/2008 - The contamination of Baxter International Inc's recalled blood thinner heparin likely was done for economic reasons, the head of the U.S. Food and Drug Administration said on Tuesday. More>>>

FDA to Open China Office This Year

-Wall Street Jornal

04/15/2008 -  The diplomatic details are still being worked out, but the FDA is likely to have a China beachhead up and running by the end of the year.

The agency is planning to put employees in place next month, and to open a full-fledged office this fall, the Secretary Health and Human Services told the Associated Press today during a visit to Singapore. More>>>

Bush's Attempts to Undermine Tort Claims Criticized

-RegWatch

04/15/2008 - An editorial in today's New York Times condemns a policy, known as preemption, which prohibits consumers from suing manufacturers if a product harms a consumer, so long as that product is in some way regulated by the federal government. More>>>

GlaxoSmithKline Confirms Receipt Of FDA Letter On Regulatory Reporting

-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. More>>>

Actos and Avandia no better than existing therapy, says DTB

-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). More>>>

Yamaha Rhino Recall: Finally, for Crushed Legs? Nope…

- Lawyers and Settlements

04/14/2008 -One can well imagine the frustration of Yamaha Rhino rollover victims, or the families of those who have died in a Yamaha Rhino rollover, after it was announced that the 2008 Rhino models have been recalled for a potential brake problem. More>>>

Heparin death tally worsens; FDA issues device warning
-InPharmaTechnologists

04/14/2008 -  The number of people whose deaths are associated with an allergic reaction to heparin has shot up as the US Food and Drug Administration (FDA) has updated its tally. More>>>

FDA Safety Changes: Carbatrol, DepoDur, Vectibix 

-MedScape

04/14/2008 - In November and December 2007, the US Food and Drug Administration (FDA) approved safety labeling revisions to advise of the risk for serious rash in genetically at-risk patients receiving treatment with carbamazepine. More>>>

The Dangers in Pre-emption

-New York Times

04/14/2008- The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices. More>>>

 

Trasylol: “What the Hell Did They Give These People?”
-Lawyers and Settlements

04/13/2008- Alice G. says that in the six years since her mother died, her family has struggled to understand what happened. With the recent news about Trasylol, Alice says she may have a better understanding of why her mother died. Although she is not yet positive her mother was given Trasylol during surgery, Alice says that what her mother went through prior to her death sounds a lot like what other patients have experienced. More>>>

Trouble in Trialville: Plans for Post-DES Clopidogrel Trial Get Bogged Down Over Trial Design, Leadership.

-TheHeart.org
04/13/2008- Almost 16 months after an FDA hearing into drug-eluting stent (DES) safety emphasized the need for a randomized clinical trial to determine, once and for all, the optimal duration of clopidogrel (Plavix, Sanofi-Aventis) plus aspirin after DES implantation, researchers, government agencies, and industry sponsors cannot agree on how it should move ahead. More>>>

Duragesic Patches: Are They Safe
InjuryBoard
04/13/2008- PriCara has recalled all lots of its 25 mcg/hr DURAGESIC patches.  These patches contain the powerful drug fentanyl.  The recalled patches have expiration dates on or before December 2009.More>>>

Johnson & Johnson seeks to put blame on regulators
-HeraldTribune
04/12/2008-For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents. More>>>

Is It Fixed? How to Check.
-New York Times
04/12/2008-A PROBLEM with recalls is that owners don’t always act on them and the next owner may suffer if the car is resold. How does a shopper know if the problem has been fixed, or even if there was a recall on the car in the first place? More>>>

Huge Recall, but Many Cars Unfixed

-New York Times
04/12/2008-AFTER six recalls to correct problems with millions of Ford Motor Company cruise-control switches blamed for almost 1,500 fires, the National Highway Traffic Safety Administration took an unusual step. In February, it issued a consumer advisory urging owners whose vehicles had not yet been fixed to have the switches disconnected immediately. More>>>

Guidant suit granted class-action status in Canada

-St. Paul Business Journal

04/11/2008 - A suit against Guidant Corp. has been granted class-action status.

A Canadian judge ruled that a group of almost 2,000 Canadians alleging they were implanted with defective defibrillators can sue the company, according to media reports. More>>>

Genetic threat
-Anchorage Daily News

04/11/2008 - The mysterious blood clot that two weeks ago threatened the life of World Cup champion skier Kikkan Randall of Anchorage may be hereditary, doctors reported Thursday. More>>>

FDA: Heparin Linked To 62 Deaths

-AHN

04/11/2008 -  The Food and Drug Administration has linked 62 deaths to heparin, a blood thinner drug manufactured in China. More>>>

A prescription for drug disaster

- Georgetown Voice

04/11/2008 - If an Ohio District Court rules in favor of Johnson & Johnson in an upcoming case, it will set the precedent that drug companies are no longer responsible for their medicines’ unadvertised side effects. This legal shield would let drug companies literally get away with murder. More>>>

Glaxo Angers the FDA

-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. More>>>

Baxter's Heparin Killed Mother and Son, Family Says

-Bloomberg

04/10/2008 -  Bonnie Hubley, 65, died in December. A month later, so did her 47-year-old son. More>>>

Bloomington Woman Says NuvaRing Nearly Took Her Life

-Central Illinois

04/10/2008 - A Bloomington woman nearly loses her life and she says it's because of switching from birth control pills to the NuvaRing. More>>>

Big Pharma & A Killer Ruling Expected From George Bush’s Activist Supreme Court

- The Moderate Voice

04/10/2008 - There is an old saying that Americans have to live with the decisions of the Supreme Court for the rest of their lives and then some, but that takes on a perverse new meaning for those who are maimed or their lives cut short by shoddily researched and falsely advertised medications that are inadequately vetted by the Food and Drug Administration and let slide by President Bush’s activist Supreme Court. More>>>

GSK Cited for Omitting Avandia Studies

-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. 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. More>>>

New York Times Examines Johnson And Johnson's Pre-Emption Defense Over Safety Of Birth Control Patch

- Medical News Today

04/09/2008 - The New York Times on Sunday examined Johnson & Johnson's use of the legal doctrine of preemption to defend against claims that the birth control patch Ortho Evra causes blood clots or other adverse effects. More>>>

Sen. Grassley Knocks Psychiatrist’s Funding from AstraZeneca

-Wall Street Journal

04/09/2008 - A University of Cincinnati psychiatrist who was the lead author of a 2002 study that concluded kids did well on AstraZeneca’s antipsychotic Seroquel has received hundreds of thousands of dollars from the company since then, according to Sen. Charles Grassley (R-Iowa). More>>>

FDA: Glaxo holds studies on Avandia

-Foodconsumer.org

04/09/2008- GlaxoSmithKline Plc failed to report all the required studies on its diabetes drug Avandia to the Food and Drug Administration, the agency said in a warning letter released on Tuesday. More>>>


Glaxo Failed to Disclose Avandia Studies, FDA Says

-Bloomberg
04/09/2008- 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. More>>>

Seroquel researcher got cash from AstraZeneca

-Fierce Pharma

04/08/2008 - Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee, who's been trying to rally support for a bill requiring drug and device makers to disclose anything of value given to doctors, raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca More>>>

Osteoporosis meds and bone collapse: weighing the risks

-Globe and Mail

04/08/2008 - Osteonecrosis of the jaw, a disease in which a patient's jawbone rots and dies, has been associated with the use of bisphosphonates, a popular class of medication for the treatment of osteoporosis. 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. 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. 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. More>>>

A dangerous legal shield for drug makers

- News Tribune

04/08/2008 - Let’s say a drug company hides damaging findings during medical trials of a new cholesterol-lowering drug. Unaware of those health risks, the federal Food and Drug Administration approves the product. More>>>

If J&J misled FDA, can patients sue?

- Fierce Pharma

04/08/2008 - Drug companies appear to be close to gaining a long-coveted prize: A shield against patient lawsuits. The Bush administration has been arguing in favor of it, saying that only the FDA has the expertise to regulate pharma. More>>>

Odds Rise for FDA Shield Against Drug Liability

-Wall Street Journal

04/07/2008 - Johnson & Johnson maintains that it can’t be sued by thousands of women who claim they were injured by the company’s birth control patch because the FDA approved the product as safe and effective. More>>>

Drug Makers Near Old Goal: A Legal Shield

- NY Times

04/07/2008 - For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents. More>>>

Doctors demand freeze on use of diabetes drug for heart patients

-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. More>>>

Lechleiter inspired by Lilly's legacy

-Indy Star

04/07/2008 - Eli Lilly and Co.'s storied history was on full display last week as Sidney Taurel, a career Lilly man, retired as chief executive and was replaced by John Lechleiter, another career Lilly man. More>>>

Eli Lilly ZYPREXA Chronicles

-Indy Star

04/06/2008 - Some fast facts on the Zyprexa controversy chronicled by a patient user. More>>>

Woman warns others not to use NuvaRing
Birth control product blamed for 12 deaths; hundreds of lawsuits filed.
- News-Leader

04/06/2008-Misty Liebert had been using a new birth control product for three weeks when she awoke at 2 a.m. on March 22 choking and gagging.

She dashed to the bathroom, lights still out, and began coughing up something in the sink. It came in waves. When she finally flipped the bathroom light on, Liebert realized it was blood. More>>>

Novartis will offer restricted Zelnorm for emergencies only
04/05/2008-Having restricted its use last year, Novartis has now served notice that it intends to take its irritable bowel syndrome off the US market completely.
The Swiss drugs giant has notified the US Food and Drug Administration that it will no longer provide Zelnorm (tegaserod maleate) as part of a restricted programme agreed with the agency in July last year. That agreement saw Novartis provide the drug to treat IBS with constipation and chronic idiopathic constipation in women younger than 55 who meet certain conditions. More>>

J&J Hid Safety Risk Data on Birth-Control Device, Women Claim
-Bloomberg
04/05/2008- Johnson & Johnson hid or altered data on the health risks of its Ortho Evra birth-control patch and flaws in the manufacturing of the device, lawyers for women suing the company claim in court papers. More>>>

Elli Lilly Zyprexa Rico Lawsuit
-PR-Net

04/04/2008 - Attorney General Richard Blumenthal sues Eli Lilly and Company, Inc. for illegally marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug's serious side effects, for more than a decade. More>>>

Suit alleges Baxter's heparin killed wife

-Chicago Tribune

04/03/2008 -  Baxter International Inc. faces a growing number of lawsuits from families who blame the company's blood-thinning drug heparin for deaths of loved ones. Heparin was used by millions of people to prevent blood clots during dialysis and other medical procedures. More>>>

Law Firms Seek Plaintiffs to Sue Yamaha

- The State Records, WV

04/03/2008 - For many ATV enthusiasts, the Yamaha Rhino may be the ideal vehicle.But the design of the Rhino may be leading it into the courtroom instead of into the great outdoors.  More>>>

Editorial: We can't afford FDA bungling on pharmaceuticals

-Mercury News

04/03/2008 -  The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs. More>>>

The bad side of Viagra

-MSN News

04/02/2008 - Recent researches showed that sildenafil and similar chemicals (like tadalafil from Cialis and vardenadil from Levitra) damage the inner ear and cause hearing loss, sometimes in just two days of drug consumption. More>>>

Man Sues Birth Control Company In Wife's Death

-CBS News

04/02/2008 - A devastated husband is blaming a popular form of birth control for the death of his young wife, and now he's filing a lawsuit against the company. More>>>

Covidien-brand heparin syringes recalled

-UPI

04/02/2008 -  The U.S. Food and Drug Administration announced the recall of 32 lots of Covidien-brand pre-filled heparin syringes because of possible contamination. More>>>

Officials Question Safety Of Overseas Drug Manufacturers

-NBC News

04/02/2008 -  Heparin is a drug used - safely - by millions of Americans to prevent blood clots. It's been around for decades. But recently, a bad batch of Heparin made hundreds of people sick and killed 19 of them. More>>>

Pre-filled syringes containing Heparin recalled

-ABC News

04/02/2008 -  Covidien is voluntarily recalling pre-filled syringes after being notified of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. More>>>

Article in ‘Drug Safety’ Identifies 62 Drugs That Can Cause Eye Disease
-Public Citizen
04/01/2008 - Physicians and patients should be aware of the slew of drugs that can cause eye disease and be diligent in identifying potential adverse effects.
More>>>

Bill seeks overseas oversight for FDA

-Politico, DC

04/01/2008 -  Concerns were raised over the blood thinning drug Heparin after the Food and Drug Administration announced that it caused an allergic reaction in more than 700 people, some of whom died. More>>>

Post-heparin, no oversight excuses

-FiercePharma, DC

04/01/2008 -  What's the long-term impact of the heparin scare? It's shattered U.S. claims of "it can't happen here," for one thing. When Chinese-made cold meds killed 120 in Panama over a year ago, Americans thought the same thing couldn't happen here. More>>>

Erythema Multiforme - Causes, Symptoms and Preventions

-LA Chronicle
04/01/2008 - Erythema multiforme is the skin problem which occurs as the reaction due to infection or medication and is discovered by Ferdinand von Hebra in 1866. In this disease a red rash is obtain on the skin which is the sequence of the spots. Sometimes they are purple in color. More>>>

Bad drugs at a pharmacy near you

-Washington Times

03/31/2008 -  The FDA believes it has discovered the contaminant in the blood-thinning drug heparin that has caused hundreds of allergic reactions and 19 deaths. More>>>

Illinois senator concerned about Heparin

-ABC News

03/31/2008 -  Concerns were raised over the blood thinning drug Heparin after the Food and Drug Administration announced that it caused an allergic reaction in more than 700 people, some of whom died. More>>>

Heparin Scare: criminal corruption, not FDA carelessness

-Blogger News

03/30/2008 -  The NYTimes has a nice “summary” article on the heparin scare today. They do a nice job, but they seem to assume that the episode is an accident, so the article it points to the FDA for failing to regulate the drug manufacturing process. More>>>

Journal Issues Warning on Two Cholesterol Drugs
New York Times

03/30/2008-Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, The New England Journal of Medicine said in an editorial published on Sunday. More>>>

Nephrologist Blamed Celebrex for Kidney Problems and Hypertension
-Lawyers and Settlements
03/30/2008- Bess W. was referred to a nephrologist to evaluate her kidney function. "All this time she was still on 200mg of Celebrex daily," says her husband Reid. "The specialist reported to her primary care physician that she had progressive renal insufficiency due to analgesic neuropathy from many years of non-steroidal and COX-2 use. He also said that her accelerated hypertension and edema are probably related to her worsening renal disease and Celebrex. More>>>

 

Patients With Blood Clots Inside Heart Stents Face Recurrence
-Bloomberg
03/30/2008- One in six heart patients who develop a blood clot inside the device used to open their clogged arteries are likely to develop another blockage, a study found. More>>>

Avandia: Meant to Help but Killed Instead
Edmonton, AB
03/30/2008- Early in August 2006, Vivian's mother went to the hospital in Edmonton to have some cancer tests done. However, when she arrived the doctors noticed that the left side of her body was swollen. They took her vital signs and noticed her heart was racing. She was admitted to hospital that day, and on further testing the doctors discovered that her heart was enlarged as well. Over the next few days the doctors were unable to bring Vivian's mother's heart rate under control and she died. More>>>

Fosamax Linked to Serious Abnormal Bone Fractures
Natural News.com
03/29/2008-On March 20, 2008, The New England Journal of Medicine published a physician group report of 15 women taking Fosamax who experienced "atypical low-energy fractures," which means their bones broke doing almost nothing – a serious kind of injury typically seen in very elderly individuals in declining health. The fact that the NEJM is reporting this is a major wake up call to anyone who hasn't figured out that Fosamax is dangerous to your health. More>>>

New Trasylol Trial Halted Due to Deaths
Lawyers and Settlements
03/29/2008- Bayer AG said that a new trial on Trasylol had to be halted because the risk of death increased due to excessive bleeding. In addition to this new trial, previous studies have shown that Trasylol has a strong link to kidney failure in patients administered the drug when undergoing heart bypass surgery. 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. More>>>

Painful shocks linked to device

-Courier Press

03/28/2008 - The defibrillator wire implanted in Belinda Jean Klein's chest was supposed to detect and correct arrhythmia's in her heart. But in a federal lawsuit, the Evansville woman claims the device delivered painful shocks that led to her hospitalization instead. More>>>

New Antipsychotics No Better For First Episodes

-Pharmalot

03/28/2008 - The so-called atypicals - including Abilify, Risperdal, Zyprexa, Seroquel and Geodon - have been hailed as more effective and easier to tolerate than the older and cheaper kind such as Haldol, which cause tremors and rigid muscles. But the new generation are no better at treating a first episode of schizophrenia, according to a study in The Lancet. More>>>

Eli Lilly Settling Zyprexa Lawsuit

-FDA News

03/28/2008 - Eli Lilly has agreed to pay Alaska $15 million to settle a lawsuit alleging the company made deceptive claims about Zyprexa, concealed the drug’s side effects and marketed it off-label for Medicaid recipients. More>>>

Alaska Suit Against Lilly Is Settled
-NY Times

03/27/2008 - The prospect of a pending Supreme Court case that could sweep away many lawsuits against drug companies loomed over Alaska’s decision to settle the state’s suit against Eli Lilly over the schizophrenia drug Zyprexa, lawyers for Lilly and the state said Wednesday. More>>>

Concerns About Supreme Court Case on Product Liability in State Courts Prompt Alaska To Settle Medicaid Lawsuit

-Kaiser Network

03/27/2008 - The $15 million settlement this week of a lawsuit filed by the state of Alaska against Eli Lilly over allegations that the company concealed data about the side effects of the antipsychotic Zyprexa More>>>

CDRH Chief: Drug-Eluting Stent Guidelines on the Way

-FDA News
03/27/2008 - A long-awaited guidance on drug-eluting heart stents is imminent, CDRH Director Daniel Schultz says. More>>>

FDA Proposes Stent Guidelines

-Wall Street Journal

03/27/2008 - The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices long after implantation. More>>>

France, Italy and Denmark Join Heparin Recall

-AHN

03/27/2008 -  Few days ago, France, Italy and Denmark joined the increasing numbers of nations recalling heparin, the popular blood-thinning medication that in recent weeks was reported to contain contaminated raw ingredients, leading to hundreds of allergic reactions and 19 deaths in the U.S. More>>>

Heparin recall spreads in Europe

-FiercePharma

03/26/2008 -  In what seems to be a daily occurrence, more countries are announcing heparin recalls. France, Italy, and Denmark recalled the blood thinner or its ingredients. More>>>

FDA Wants Longer Studies and Harder Endpoints for Drug-Eluting Stent Approvals

-MedPage Today

03/26/2008 - The FDA proposed today that new drug-eluting stents accumulate at least 12 months of data, with twice that experience for a substantial number of patients, before the devices are submitted for approval. More>>>

Lilly Settles Alaska Suit Over Zyprexa

-NY Times

03/26/2008 - Eli Lilly has agreed to pay $15 million to the state of Alaska to settle a lawsuit claiming that the company’s schizophrenia drug Zyprexa caused patients to develop diabetes, Lilly and the state said Wednesday morning. More>>>

Lilly settles Zyprexa case with Alaska for $15 mln

-Reuters

03/26/2008 - Eli Lilly and Co on Wednesday said it agreed to pay $15 million to settle a lawsuit by the state of Alaska accusing it of concealing possible side effects from Zyprexa, its widely used schizophrenia medicine. More>>>

Lilly agrees to $15 million payout to settle Alaskan Zyprexa case

-PharmaTimes

03/26/2008 - US drug giant Eli Lilly has agreed to pay the state of Alaska $15 million to settle claims that its Medicaid program was not adequately warned over potential side effects from the use of its antipsychotic Zyprexa. More>>>

U.S. government examining doctor kickbacks for medical devices

-International Herald Tribune

03/26/2008 -  The U.S. government is turning the spotlight on doctors in a long-running investigation into suspected kickback payments to hip and knee surgeons made by the orthopedic device industry. More>>>

Yamaha side-by-side vehicles recalled
- UPI

03/25/2008 - The Consumer Product Safety Commission announced the recall of 2008 models YXR450 and YXR700 Yamaha-brand side-by-side vehicles due to a safety hazard. More>>>

China Requires Heparin Makers to Get Raw Material From Registered Suppliers
-FDA News

03/25/2008 -  China’s Ministry of Commerce is requiring local heparin makers to increase testing of raw materials, improve postsale tracking and ensure their raw material comes from registered suppliers.  More>>>

Yamaha recalling Rhino side-by-side vehicles

- ABC News

03/25/2008 - Yamaha is recalling about 7,800 Rhino Side-by-Side vehicles due to a failure with the brakes. More>>>

CPSC Posts Recall to Its Web Site

- CPSC

03/25/2008 - The U.S. Consumer Product Safety Commission (CPSC) announced today that the following voluntary recall alert was posted in cooperation with the firm listed below. More>>>

Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge

-Tort Deform

03/25/2008 - The state of Alaska is suing Eli Lilly (NYSE:LLY) for failing to disclose health risks (like diabetes and weight gain) allegedly associated with Lilly’s hugely profitable “atypical antipsychotic” drug Zyprexa. More>>>

Zyprexa: Balancing Serious Side Effects With Serious Illness

-Wall Street Journal

03/25/2008 - Lawyers for the state of Alaska have spent weeks arguing in an Anchorage courthouse that Eli Lilly hid the dangers of its antipsychotic drug Zyprexa — a claim Lilly denies. More>>>

Batches of Heparin Are Recalled

In France, Italy and Denmark

-Wall Street Journal

03/25/2008 -  Batches of the blood-thinning drug heparin, and some ingredients used to make it, are being recalled in France, Italy and Denmark because they are contaminated or suspected of being contaminated, a spokesman for the European Medicines Agency, or EMEA, said Tuesday. More>>>

Learning from the heparin fiasco
-LA Times

03/25/2008 -  Just two years ago, the U.S. government was confiscating Canadian pharmaceuticals that had been ordered by mail and online by American patients looking to save money. The stated rationale was that consumers had to be protected from drugs that might fail to meet this country's manufacturing standards. More>>>

Heparin recall widens in US
-Outsourcing-pharma.com

03/25/2008 -  The heparin recall has widened after a lot of heparin sodium USP active pharmaceutical ingredient (API) produced by Scientific Protein Laboratories (SPL) was found to contain a heparin-like contaminant. More>>>

Birth Control Patch Under Fire

- NBC News

03/24/08 - The birth control patch gives millions of women the freedom of not taking a pill every day. But one Bay Area woman believes that convenience caused her a potentially life-threatening condition and now she's part of a class action lawsuit. More>>>

Man injured in ATV crash
- Newsreview

03/24/2008 - A Canadian man was injured Saturday in an all-terrain vehicle crash on the sand dunes near Winchester Bay. More>>>

Duragesic Patch: Fentanyl is a Cousin to Heroine

- Lawyers and Settlements

03/23/2008 - While fentanyl pain patches under the brand name Duragesic and other generics are described as a godsend for people with chronic pain, abuse of the highly potent drug is on the rise, especially by young people. More>>>

New Focus of Inquiry Into Bribes: Doctors
-NY Times
03/22/2008 -  A long-running federal investigation into the orthopedic device industry’s suspected kickback payments to hip and knee surgeons now has the doctors in the spotlight. More>>>

FDA Identifies Contaminant in Heparin API, Investigation Shifts to Source
-FDA News

03/21/2008 -  The impurity detected in the active pharmaceutical ingredient (API) used in Baxter’s recalled heparin products is a highly sulfated form of chondroitin sulfate, a chemical cheaper to manufacture than bulk heparin sodium, according to the FDA. More>>>

China clamps down on production of Heparin
-Baltimore Sun

03/21/2008 -  China announced today it is clamping down on production of Heparin in the latest sign that suppliers there were to blame for contamination of the blood-thinning drug that has killed as many as 19 Americans. More>>>

Another Bad Break For Merck?
-Pharmalot

03/20/2008 - Researchers report that long-term use of its Fosamax osteoporosis drug is associated with unusual fractures of the thigh bone, HealthDay writes. More>>>

Lawsuit: Organon's NuvaRing caused young mom's deadly blood clot

-Philadelphia Inquirer

03/20/2008 - The widower of a New Jersey woman who died suddenly while using the NuvaRing contraceptive is suing its maker, claiming the device caused a deadly blood clot. More>>>

China Confirms It’s the Source of Heparin Contaminant
-Wall Street Journal

03/20/2008 -  China’s State Food and Drug Agency has confirmed that the contaminant in Baxter’s heparin was introduced in China, Bloomberg reports. More>>>

Heparin Discovery May Point to Chinese Counterfeiting
-NY Times

03/20/2008 -  Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting. More>>>

Heparin contaminant identified
-LA Times

03/20/2008 -  A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday. More>>>

Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device
-Forbes

03/20/2008 - Schering-Plough Corp. is being sued by a man who claims his wife died as a result of using the drug company's NuvaRing contraceptive device, according to a statement by the man's lawyers Thursday. More>>>

Widower sues NJ contraceptive producers for wife's death
-Star Ledger

03/20/2008 - A Toms River man is suing the companies that produce NuvaRing, the contraceptive he believes led to his wife's death in December, the Asbury Park Press reports. More>>>

Medical Minute: MRI myths and misconceptions
-Penn State Live

03/19/2008 - In recent years, there has been growing recognition of a condition called nephrogenic sclerosing fibrosis or NSF that is related to exposure to MRI contrast agents. More>>>

Former Biotech CEO Indicted on Fraud Charges

-Wall Street Journal

03/19/2008 - The feds have indicted a former biotech CEO, arguing that he committed criminal acts when he promoted a drug for uses that hadn’t been approved by the FDA. More>>>

Contaminant found in heparin

-Yahoo News

03/19/2008 -  U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug. More>>>

Handling Heparin
-PharmExec.com

03/19/2008 -  FDA isn't yet ready to say that it knows why US patients died after taking the blood thinner heparin, but it has announced what sounds like a strategy for testing and controlling import of the drug in a series of cryptic poster-like documents. More>>>

Scientists Near Source of Altered Heparin
-NY Times

03/19/2008 -  Scientists investigating a mystery contaminant in the blood thinner heparin are closing in on what they believe is a counterfeit substance, most likely made in China from animal cartilage, that was chemically altered to act like the real drug. More>>>

Chinese Heparin Was Probably Cut with Counterfeit Substance
-eNews 2.0

03/19/2008 -  Federal drug regulators announced that the blood-thinning drug Heparin that had been linked to several deaths and hundreds of allergic reactions was contaminated with a fake ingredient got there by mistake or by fraud. More>>>

Lilly Zyprexa-Claim Losses May Climb to $1.83 a Share

-Bloomberg

03/18/2008 - An adverse jury decision in Alaska may be the first step in tripling to more than $3 billion Eli Lilly & Co.'s costs of resolving lawsuits over Zyprexa, which generates more than one-fourth of the company's revenue.