Framingham pharmacy may be source of fungal meningitis outbreak blamed for 4 deaths

Massachusetts and federal health officials have reportedly identified a Framingham pharmacy as the source of injectable steroids that may have infected more than 25 people, four fatally, with a rare form of fungal meningitis.

The pharmacy, New England Compounding Center, recalled three lots of Methylprednisolone Acetate on Sept. 26, according to the US Food and Drug Administration (FDA). The injectable steroid from New England Compounding is primarily used to ease back pain.
The Massachusetts Department of Public Health released a statement Wednesday night saying the agency is collaborating with the FDA, the US Centers for Disease Control and Prevention, and public health officials in other states to identify the cause of the three-month-old outbreak of aspergillus meningitis that has sickened people in Florida, Maryland, North Carolina, Tennessee, and Virginia.
Eighteen of the infected patients nationwide are from Tennessee, where that state’s Department of Public Health said investigators believe infections started in early July. Five of the cases there were identified in the previous 24 hours, the Tennessee department said Wednesday.
This is not the first time problems have been revealed at the Framingham company. Federal authorities received a complaint about an alleged practice that could have contaminated an injectable drug with microbes.
It has been reported that the FDA sent New England Compounding Center a lengthy warning letter in late 2006 detailing the outcome of an inspection that began in September 2004 and ended in early 2005. The letter listed a number of issues, including a concern about splitting and repackaging the injectable colorectal cancer drug Avastin. The 2006 letter also warned the company of health risks that could be caused by compounding an anesthetic cream. Four other compounding pharmacies received a similar warning.
Pharmaceutical companies are in the business of manufacturing and selling drugs to make a profit. Manufacturers are constantly introducing new drugs into the market and, each year, thousands of people are injured or killed due to dangerous and defective characteristics.
The FDA is the primary governmental agency involved in overseeing the introduction and performance of new drugs and medications. In certain circumstances, the FDA may recall a dangerous drug or may require that certain warnings accompany the product. Examples of drugs recently acted upon by the FDA include Rezulin, Propulsid, Lotronex, Ephedrine (herbal) and PPA. Other drugs believed by many to present unacceptable risks to patients include Arava, Baycol, Remicade, and Serzone. Defective drug cases often involve evaluations of scientific studies and assessments of the pre-market testing and investigation performed by the drug manufacturer.
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