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ANDA 34 articles

FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died. Investigators now know that the pre-filled heparin and saline syringe Fullerton used was ... Read More

FDA clears Baxter in deaths following heparin injections

Baxter Healthcare Corp. has been cleared by the Food and Drug Administration (FDA) in the deaths of two patients at a Delaware hospital following an injection of the drug maker’s blood thinner heparin. The FDA attributed the two deaths, and the illness of a third patent, to existing medical conditions. All three patients suffered intercranial bleeding following injections of heparin. Announcement of the deaths and illness at Beebe Medical Center in Lewes, Delaware, raised immediate concern at the hospital, which promptly notified the FDA and Baxter. The incidents were far too similar to the 2007 heparin scandal in which more ... 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

Lawmakers debate safety of importing drugs

Congress continues to debate the notion of allowing people to buy inexpensive drug from other countries, as the Obama administration is encouraging, but the stickler seems to be ensuring the safety of those imported drugs, according to Portfolio. Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured. After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood ... Read More

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. Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in ... Read More