Medtronic Issues Precautionary Recall of Heparin-Coated Products

-FDA News

05/13/2008 - Medtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries. 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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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: 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 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

-LawyersandSettlements

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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>>>

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

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>>>

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>>>

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

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>>>

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>>>

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>>>

FDA plans wider foreign inspection approach

-Food Production Daily

03/18/2008 -  The US Food and Drug administration (FDA) is seeking permission from the Chinese government to install eight full time FDA officials in the country, as part of plans to improve monitoring of exported food manufacturing across the globe. More>>>

FDA Instituting Testing Program for Imported Heparin
-FDA News

03/18/2008 -  As regulators worldwide are increasingly concerned that the supply of heparin active pharmaceutical ingredient (API) might be contaminated, the FDA is implementing a program to test all heparin entering the U.S. More>>>

FDA moves to allay drug-import fears

-FiercePharma

03/17/2008 - Just as the Fed is scrambling for new initiatives to shore up the U.S. financial system, the FDA is hustling up new programs designed to shore up confidence in drug safety--and in its own ability to ensure it. More>>>

Germany Asks Drug Firms to Test Heparin

-Wall Street Journal

03/12/2008 - Germany's medical regulator has asked companies selling the blood thinner heparin in Germany to test all batches of their product for contamination, the regulator said. More>>>

China-made heparin scare spreads beyond US

-Outsourcing-Pharma.com

03/11/2008 -  The made-in-China heparin scare has now spread beyond the US, with Germany and Japan both recalling the drug. More>>>

How Heparin Maker in China Tackles Risks
-Wall Street Journal

03/10/2008 -  Inside Shenzhen Hepalink Pharmaceutical Co.'s high-tech factory in this southern China boomtown, workers in blue protective suits, surgical masks and gloves produce the active ingredient for heparin, the widely used blood-thinning medication. More>>>

CHUCK RIPS FDA OVER CHINA RISK
-New York Post

03/10/2008 -  An anemic Food and Drug Administration needs a $500 million infusion to increase its overseas inspections after a violations-riddled Chinese factory was linked to the contaminated blood thinner Heparin, which has killed 19 people in the United States, Sen. Chuck Schumer charged yesterday. More>>>

China Washes Hands on Heparin Purity

-Wall Street Journal
02/27/2008 - If the U.S. is concerned about the quality of raw heparin imported from China, the Americans need to make sure the proper controls are in place, China’s State Food and Drug Administration said today. More>>>

China Has No Fault for Bad Quality Heparin

-enews2.0
02/27/2008 - Commenting on an investigation into the recalled drug heparin, China’s State Food and Drug Administration declared Wednesday that it strictly controlled chemicals used in pharmaceuticals, but the importing countries should be the ones responsible for ensuring the imported products are safe. More>>>

Baxter Suspends Multidose Heparin Production After Allergic Reactions
-FDA News
02/13/2008 - Baxter and the FDA are investigating manufacturing facilities and processes for multidose Heparin after a spike in serious adverse events associated with it caused the company to suspend production of multidose vials of the drug. More>>>

If you or a loved one have experienced Heparin Sodium Injection side effects you may be entitled to compensation. Contact the Heparin 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 Heparin side effects, a possible Heparin class action lawsuit, or any other type of Heparin Sodium Injection litigation.

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