News Tagged ‘tainted heparin scandal

Congressman demands answers on tainted heparin scandal

rep joe barton 100x100Rep. Joe Barton of Texas wants the Food and Drug Administration () to turn over databases stemming from last year’s tainted heparin scandal that killed more than 80 Americans and injured hundreds more, according to NASDAQ.com. At a public hearing last week, Barton raised concerns that the agency doesn’t know for sure what caused the contamination.

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FDA panel recommends agency approval of heparin alternative

blood cells 100x100A Food and Drug Administration () advisory panel voted last week to recommend agency approval of experimental rivaroxaban, according to Forbes. The medication, made by Johnson & Johnson and Bayer Healthcare Pharmaceuticals, is designed to be used on a short-term basis to prevent pulmonary embolism and deep-vein thrombosis in patients having total knee or hip replacement surgery. Blood clots are common after such surgeries.

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Hamburg, Sharfstein to head troubled FDA

The Obama administration has named two doctors to head up the much-criticized U.S. Food and Drug Administration (), individuals who are known for speaking out about public safety. Sources say Margaret Hamburg, a physician and former New York City health commissioner, was selected to run the agency with Joshua Sharfstein, of the Baltimore health commission, as her chief deputy, according to The Washington Post.

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Class action lawsuit filed against Baxter over tainted heparin scandal

A class action lawsuit has been filed against Baxter claiming the drug maker substituted an ingredient in its heparin with a cheaper, more dangerous one in order to reap more profits, according to the Madison-St. Clair The Record. Twenty-eight people are named in the lawsuit, most of whom are spouses of individuals who died after receiving injections of the tainted heparin. The lawsuit was filed in St. Clair County Court in Illinois.

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Scientists propose new testing standards for heparin

Scientists are proposing new standards for testing the quality and safety of heparin with new equipment that can analyze a broader range of impurities than the screening tools currently in use, according to the Daily Herald. The proposal stems from last year’s tainted heparin scandal that resulted in the deaths of more than 80 Americans and illness in hundreds more. Batches of were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s plant. OSCS is a -mimicking contaminant that can cause serious allergic reactions in humans.

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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 . Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a -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 were recalled.

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Torti named interim commissioner of FDA

chief scientist and principal deputy commissioner Dr. Frank Torti will serve as the agency’s acting commissioner when Dr. Anderew Von Eschenbach leaves office this week, a position he will hold until the Obama administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.

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Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Actor Dennis Quaid and his wife Kimberly now have closure in their year-long heparin overdose lawsuit against Cedars-Siani Medical Center, according to OK! and Entertainment Tonight. The entertainment media reported that a Los Angeles judge has signed off on the $750,000 settlement the couple reached with Cedars-Siani last month. According to the settlement, the hospital did not admit wrongdoing in the potentially fatal overdose of heparin that was accidentally administered to the couple’s newborn children Zoe Grace and Thomas Boone Quaid. The settle also allows for the couple to pursue claims for their children in the future. The California Department of Public Heath fined Cedars-Siani $25,000 for the error.

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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.”

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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 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.

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