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contaminated heparin 33 articles

China heparin producer warned by FDA over violations of current good manufacturing practices

U.S. Food and Drug Administration (FDA) officials inspecting Chinese drug maker Dongying Tiadong Pharmaceuticals Co., Ltd., found “significant deviations” from current good manufacturing practices in its manufacturing of the blood thinner heparin. Dongying Tiadong was warned by French regulators over similar violations last March. The agency cited the company in its testing of crude heparin batches saying it failed to adequately investigate and document out-of-specification (OOS) results “repeatedly and without justification.” “Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes ‘testing into compliance.’ This practice is unscientific and objectionable under current good manufacturing practices,” the agency said ... Read More

USP updates standards for heparin

A recent report in Huliq News documents efforts by the U.S. Pharmacopeial (USP) Convention to improve the safety of blood thinner heparin by revising its written and physical standards for the drug. The update comes at the request of the U.S. Food & Drug Administration (FDA) following a 2008 public health crisis when more than 200 people died after being administered contaminated heparin. According to its web site, U.S. Pharmacopeia is an official public standards-setting authority for all prescription and over-the-counter medicines and other health care products manufactured in the United States. It is a non-governmental, not-for-profit public health organziation ... Read More

Four lawsuits filed in contaminated heparin case

Four lawsuits were filed last month in Cook County, Illinois court against the makers of the blood thinner heparin, claiming the product the company manufactured was contaminated and caused patients to die. Named in the lawsuit are Baxter International, Baxter Healthcare Corporation and Scientific Protein Laboratories. Both Baxter International and Baxter Healthcare have been sued 24 times in 2009 alleging the drug maker’s heparin was contaminated and led to death or serious injury. In February 2008, the Food and Drug Administration (FDA) ordered a recall of nine lots of Baxter’s heparin manufactured in the company’s China plant after more than ... Read More

New deaths, illness following heparin use spark FDA investigation

The Food and Drug Administration (FDA) is testing batches of the blood thinner heparin after two people died and one became ill after receiving doses of the heparin, according to the Wall Street Journal. All three incidences occurred at the Beebe Medical Center in Lewes, Delaware, and all three were given heparin supplied by Baxter, the same drug company at the center of last year’s contaminated heparin scandal. That heparin, which killed more than 80 people and injured hundreds more, was manufactured in China. The latest batch was manufactured in Ohio. The heparin in question involves premixed intravenous bags of ... Read More

Obama's pick for FDA commissioner wants to restore trust in agency

President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the FDA, according to Boston.com. She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing. If confirmed, one of Dr. ... Read More

FDA approval for marketing generic Lovenox expected

The expiration of exclusivity period for Sanofi Aventis’ blood thinner Lovenox has expired, moving Momenta Pharmaceutical Inc. one step closer to gaining approval from the Food and Drug Administration (FDA) to manufacture and market is generic Lovenox, M-Enoxaparin, according to Momenta’s first quarter 2009 Earnings Call. Anticoagulants are often administered to patients before undergoing some surgeries and medical procedures to reduce the risk of life-threatening blood clots. Lovenox has been touted as an effective replacement for the blood thinner heparin in patients undergoing abdominal surgery. Heparin carries a laundry list of side effects such as nausea, vomiting, abdominal pain, diarrhea ... Read More

Congressman demands answers on tainted heparin scandal

Rep. Joe Barton of Texas wants the Food and Drug Administration (FDA) 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. The FDA has previously claimed the raw heparin originated from a manufacturing company in China and was purposefully contaminated with a man-made chemical, over-sulfated chondroitin sulfate, OSCS. The Chinese government disagrees. Barton, a ranking member of the House Energy and Commerce Committee, has long ... Read More

FDA accuses Chinese companies of lying about role in heparin scandal

The Food and Drug Administrating (FDA) is accusing two Chinese pharmaceutical manufacturing companies of lying to federal regulators about their role in shipping batches of contaminated heparin into the United States between 2007 and 2008, according to Easy Bourse. Letters sent by the FDA to Qingdao Jiulong Biopharmaceuticals Co. Ltd. and Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., says that during inspection of the plants in 2008, the agency “uncovered untrue statements and information by your firm to the agency.” In late 2007 the FDA began receiving reports of patients experiencing severe reactions after receiving injections of the blood ... Read More

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 (FDA), 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. Sharfstein made headlines in 2007 when he convinced the FDA to restrict the use of over-the-counter children’s cough and cold medicines based on evidence they can cause serious health complications and even death in children. If ... Read More

Baxter named in contaminated saline syringe lawsuit

Pharmaceutical giant Baxter International faces yet another lawsuit, this time for playing a role in the distribution of a contaminated saline syringe that was used on a woman who afterward suffered serious medical problems that may have led to her death a year later, according to the Hays Daily News. Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later ... Read More