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Meningitis Outbreak blamed on Compounding Facility Highlights Dangerous Pharmaceuticals Risk

Tainted back-pain injections are being blamed for a quickly escalating outbreak of a deadly fungal meningitis strain that has killed 23 patients and sickened about 300 since the first case was reported 10 days ago.

The U.S. Food and Drug Administration reports the contaminated doses of methylprednisolone acetate were mixed at the New England Compounding Center and shipped to 23 states, including the Carolinas. Three lots of the injectable steroid — some 81,000 doses — were quickly recalled. But the NECC has since recalled its entire product line after the FDA also voice concerns about the safety of an ophthalmic drug injected during eye surgery and a cardioplegic solution produced by the company.

The tainted drugs were shipped to hospitals, clinics and healthcare facilities nationwide on May 21. Patients who believe they have been treated with a product from the NECC should remain vigilant for signs of infection and should speak to their healthcare provider. At least two patients have died after contracting meningitis in North Carolina. Some symptoms may be similar to those of the flu, including fever, headache, vomiting or nausea. Other signs may include pain or swelling at the injection site, redness or discharge, and chest pain.Health officials report a number of patients have also suffered a stroke. Meningitis is a life-threatening medical emergency involving swelling in the membrane surrounding the brain and spinal column. Thus, direct spinal injections, like those in this case meant to treat back pain, could be a particularly effective way to spread the illness. It does not spread from person-to-person contact.

The New York Times reports problems at the company dating back to 1999. The Massachusetts Department of Health released hundreds of pages of documents this week that reveal complaints about the Framingham compounding pharmacy began in April 1999, less than a year after it opened. Still, it was permitted to remain in operation, mixing batches of prescription medication used nationwide. A 28-page list of NECC customers released by the FDA shows the center sent medications to hospitals and clinics in every state except Missouri.

While these compounding or mixing facilities use FDA-approved products, they are not subjected to the same oversight. In fact, they are regulated by the individual states. Congress is already moving, ostentatiously calling for hearings in the wake of this tragedy. But the truth of the matter is that it has been Congress’ failure to act that has endangered the public in the first place.

As Reuters News reports, senators met more than a decade ago and heard testimony from the FDA and other advocates about the risks of pharmacies mixing or altering drugs with little federal oversight. At that time, 10 of 29 drugs tested at 12 such facilities failed to meet quality control measures. Still, Congress ultimately killed a bill that would have created federal oversight of these facilities. In 2007, the late Senator Edward Kennedy, who long represented Massachusetts where NECC is located, introduced the Safe Drug Compounding Act. Successful lobbying by the industry killed the measure.

As a result, state boards of pharmacy, which typically have half a dozen inspectors and thousands of pharmacies, are responsible for oversight.

If you’ve been injured by a dangerous drug or defective medical product, contact Grimes Teich Anderson LLP. Call 1.800.533.6845. No Attorney Fees Until You’ve Been Paid.

Additional Resources:
Documents in Meningitis Case Show Complaints in 1999, By Sabrina Tavernise and Andrew Pollack, The New York Times, Oct. 22, 2012.

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