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contaminated heparin 33 articles

Heparin producer's insurers file lawsuit

The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled. American Capital purchased 87 percent of Scientific ... Read More

CDC study provides details on OSCS-laced heparin

The New England Journal of Medicine reported that the Centers for Disease Control and Prevention (CDC) in a study titled “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” has confirmed the cause of serious adverse reactions in late 2007 were due to heparin contaminated with oversulfated chondroitin sulfate (OSCS). In the study, the CDC also determined that the contaminated heparin was linked to 152 adverse reactions in 113 patients from 13 states from Nov. 19, 2007 through Jan. 31, 2008. The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions ... Read More

FDA launches pilot project to oversee foreign drug products

The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S. The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program ... Read More

Heparin scandal makes 2008 top 10 lists

The tainted heparin scandal was listed as the No. 1 story in the Chicago Tribune’s “The Top 10 local business stories of 2008.” Early in 2008, more than 80 Americans died and hundreds more were sickened after receiving injections of heparin. An investigation found that batches of heparin manufactured in Baxter International’s China facility had been tainted with a contaminant that caused severe allergic reactions in patients who received the doses. As a result, lots of heparin manufactured by Baxter International were recalled. The Chicago Tribune story says both the FDA and Baxter International believe the heparin was “intentionally adulterated ... Read More

Consumer groups, institute team up to urge FDA reform

The National Academies of Sciences Institute of Medicine, the Consumer Federation of America and the Center for Science in the Public Interest have joined together to urge the incoming Obama administration to address food safety issues that have plagued the FDA in the past few years. However, the Institute of Medicine and the consumer groups disagree on the legalities, according to Flesh and Stone. According to the report, the Institute of Medicine issued a statement recommending the USDA’s Food Safety and Inspection Service and the food safety activities of the FDA within HHS should be unified. The consumer groups argue ... Read More

Drug makers rush to produce new blood thinners

New blood-thinning medicines are in the works and to offer doctors more options in treatment and prevention of blood clots, according to Bloomberg. Bloomberg reports that at least six companies are working on blood thinners to take advantage of a growing need. According to Datamonitor, a London-based research company, the anticoagulation drug market is expected to reach $20 million by 2012. Blood thinners are routinely given to patients before certain types of surgery and treatments such as kidney dialysis to prevent blood clots from forming. Clots that do not naturally dissolve can travel through the blood stream and end up ... Read More

Tainted heparin may have caused death of infant

An infant may have been among the victims of the tainted heparin scandal earlier this year, according to WorldFocus consultant Peter Eisner, who has reported on the heparin crisis over several months. Eisner reports that Julien, the son of Alex and Ann Oryschak, died Nov. 19, 2007, after becoming ill. The Oryschaks believe that heparin may have lead to their infant son’s untimely death, and they want to share their story in hopes of influencing changes in drug regulations. Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and ... Read More

Barton wants answers from FDA about heparin scandal

Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, appears to be fed up with the FDA’s reluctance to provide details of the tainted heparin scandal that first came into public light earlier this year, according to CNN Money. That scandal resulted in the deaths of more than 80 Americans and adverse reactions in hundreds more, and led to an agency recall of lots of the blood thinner manufactured in Baxter International’s Chinese facility. Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said ... Read More

FDA commissioner announces plans to resign next month

The Associated Press reported today that Food and Drug Administration Commissioner Dr. Andrew von Eschenbach will resign from his post effective Jan. 20, the same day president-elect Barack Obama takes office. Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year. The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots ... Read More

Congressman questions FDA's slow action on heparin seizure

A Texas congressman is questioning why the FDA waited six months to seize lots of contaminated heparin from an Ohio company, according to CNN Money. Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin. CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s ... Read More