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tainted heparin 39 articles

FDA notifies public about changes to heparin potency

The blood thinner heparin will now include a new reference standard and test method that is used to determine the potency of the drug and detect impurities that may be present in it, according to a safety alert issued by the Food and Drug Administration (FDA). The change is effective as of October 1, 2009, and will harmonize the USP unit dose with the WHO International Standard unit does, which will result in an approximately 10 percent reduction in the potency of the heparin marketed in the United States. The alert was issued to pharmacists, physicians, hospital risk managers and ... Read More

Watchdog group pressures FDA about contaminated syringes

Watchdog group Project on Government Oversight (POGO) is asking the Food and Drug Administration (FDA) inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products. POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. ... Read More

Baxter says it's not responsible for recent heparin deaths, illness

It’s like a bad dream happening all over again – people falling ill or dying after receiving doses of the blood thinner heparin. In 2007, tainted doses of heparin killed more than 80 Americans and injured hundreds more. And while investigations into the cause continue, the culprit was found to have been over-sulfated chondroitin sulfate (OSCS) a heparin-mimicking contaminant that made its way into batches of heparin that were manufactured in Baxter International’s China plant. Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. ... 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

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 panel recommends agency approval of heparin alternative

A Food and Drug Administration (FDA) advisory panel voted last week to recommend agency approval of experimental blood thinner 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. Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk ... 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

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

New budget supports plan for importation of drugs

As a presidential candidate, President Barack Obama said he supported individuals’ rights to import cheaper drugs from other countries provided the FDA beefed up its inspections to ensure the imports are safe. His new budget plan backs up that claim, according to Reuters. The plan, released earlier this week, says it “supports the Food and Drug Administration’s (FDA’s) efforts to allow Americans to buy safe and effective drugs from other countries.” However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health ... Read More

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. AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted. Earlier this week, workers ... Read More