Tainted Drugs Lead to Meningitis Outbreak and Serious Spinal Infections
By Tamara Wilhite
(HealingTalks) In late 2012, a meningitis outbreak was tied to methyprednisolone acetate, a injected steroid, that was contaminated with Exserohilum fungus. Potentially contaminated products were shipped to at least 23 states and up to 14,000 people were exposed. An incubation period of up to seven weeks caused the epidemic to take months to be fully realized, assuming no more of the recalled drugs were used.
Timeline of the Meningitis Epidemic
- New England Compounding Center had been previously cited for bacterial contamination in its clean rooms and the Center for Disease control found medications shipped on or after May 21, 2012 to be potentially tainted with bacteria or fungi.
- On September 24, 2012, the CDC recorded six meningitis cases in Tennessee caused by a rare fungus.
- In October, the Massachusetts board that regulates pharmacists suspended the licenses of the three pharmacists at New England Compounding Center. The compounding center’s license was also revoked.
- On November 1, 2012, the FDA found other fungal strains in other medicines made by New England Compounding Center or NECC. The company recalled all of its products, not just the steroids at the center of the outbreak. Ameridose, a drug manufacturer that worked with New England Compounding Pharmacy, also recalled its products after investigation found that they may not meet FDA standards for sterility.
Impact of the Meningitis Epidemic
At least 39 people have died, and over 460 have become ill with fungal infections due to the neglect of NECC. Roughly a third of the cases occurred in Michigan, while Tennessee was home to another large population of patients. Cases were reported as far away as Texas and Idaho.
Patients who did not develop meningitis have shown other symptoms such as headaches and internal abscesses that required surgical removal. Patients taking antifungal medications to cure their infections suffer from exhaustion, blurred vision, weakness and confusion. Other patients have suffered spinal infections and inflammation of the spine. Fortunately, this type of fungal meningitis is not spread from person to person, limiting the potential scope of patients to those who are injected with tainted drugs. However, lots of the drugs were sent to medical facilities on the East coast and California.
Lawmakers are reviewing a number of options to prevent a future outbreak. Massachusetts is looking at options to better police compounding pharmacies, since they have not received the same level of supervision as pharmaceutical manufacturers. The state of Massachusetts received at least twelve complaints about NECC.
Addressing FDA Negligence in Regard to the Meningitis Epidemic
Federal officials are also researching options to prevent a future epidemic. The Food and Drug Administration had prior reports that drugs produced at New England Compounding Center had been linked to illnesses and possible cases of meningitis as early as 2002. However, the FDA did not respond to the 2002 cases until 2008, and when it issued a warning to NECC. Nor did the FDA conduct follow up inspections, either between the first illnesses in 2002 and its 2008 warning or after its warning in 2008 that NECC could be subject to future inspections. Nor did the FDA act when Colorado reported breaches of pharmacy regulation by NECC when it sent drugs to patients in Colorado without receiving a formal prescription for each patient first.
A bill has thus been introduced in the House of Representatives to increase the FDA’s federal oversight of compounding pharmacies and as the FDA has in the past limited its supervision to only large scale pharmaceutical manufacturing. Hopefully this will address this issue in the future.
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