› $4.85 Billion settlement in drug case
The Food and Drug Administration (FDA) announced this week safety labeling changes on the blood thinner heparin to include warnings of fatal medication errors that have resulted in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT), in particular in neonates, or infants less than a year old.
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.
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.
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.
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.
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.
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.
Petr Zelenka liked the excitement around crisis situations and the constant activity of hospital staff, which is why he pursued a position at an anaesthesiological-resuscitation ward at Havlickuv Brod hospital in the Czech Republic. To further his excitement, he administered heparin to patients between May and September 2006, which resulted in serious health complications and even death in some patients.
Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”
In an ongoing effort to ensure the safety of foods and drugs imported to the United States, the FDA is opening offices in foreign countries to oversee quality control of those products. The agency announced this week that it has opened two offices in India, according to Med Page Today.
