Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

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.

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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.

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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.

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A researcher at the University of North Carolina at Chapel Hill received a $1.48 million grant from the National Institutes of Health to support research into Recomparin, a synthetic version of the blood thinner heparin, according to the Triangle Business Journal. Associate Professor of Pharmacy Jian Liu invented the synthetic anticoagulant and hopes the grant money will help him perfect the drug and find better ways of synthesizing it.

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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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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.”

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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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In an effort to ship heparin- and saline-filled syringes faster, workers at a facility in North Carolina failed to check sterility and then falsified manufacturing dates to make it appear those safeguards were followed, according to an Associated Press report. Those syringes, as it turned out, were tainted with a bacteria known as Serratia marcescens and may have lead to five deaths and hundreds of infections in those who received them.

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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.

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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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