News Tagged ‘ANDA

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 blood thinner 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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FDA knew of tainted syringes two years before inspecting plant

The FDA received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press.

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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 heparin were later found to have been contaminated with oversulfated chondroitin sulfate (OSCS) during manufacturing at Baxter International’s China plant. OSCS is a heparin-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 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.

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Torti named interim commissioner of FDA

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 administration appoints a new leader and the Senate approves the choice, according to Scrip World Pharmaceutical News.

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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.

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Pharmacy tech steals bagfuls of heparin and other drugs

Pharmacy technician Wanda Lopez told guards she had left her wallet in the pharmacy at Shaughnessy-Kaplan Rehabilitation Hospital in Salem, Mass. Guards led her back to the pharmacy, where she used her key code to re-enter the room with the guards. She searched for her wallet and as her search became fruitless, guards left her alone. Shortly afterward, the guards saw Lopez walking around the hospital with a plastic bag covered by her coat. It was the third trip the pharmacy technician made to her car with bags taken from the hospital, according to a hospital employee. That’s when security guards became suspicious, according to The Salem 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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Diabetic questions safety of insulin in light of heparin scandal

Meet Allie Beaty. As a diabetic, her life depends on insulin. She wants to make a difference for others like her, make “the world safer for people with diabetes,” she says on her Web page, Alliesvoice.com. So Allie established a diabetes think group and shares ”Love Diabetes” videos on YouTube to push her mission.

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