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Tue October 16, 2012
Meningitis cases in Michigan reach 46, other meds could be involved
The Michigan Department of Community Health said the number of meningitis cases associated with the recent outbreak reached 46 yesterday. Three deaths in Michigan are linked to the outbreak.
In the meantime, the New York Times reports the FDA warns other drugs could be involved:
The Food and Drug Administration reported on Monday that the company’s products may have also caused other types of infections in patients who have had eye operations or open-heart surgery.
The new warning is based on only two cases, and it was not known for sure whether the company’s drugs had caused the infections. Officials did not say how many people may be at risk, but the number is potentially significant, and a statement from the agency warned doctors, “The F.D.A. recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today’s announcement.”
The company responsible for the outbreak, the New England Compounding Center in Framingham, Mass. was shut down.
The Times reports at least six states, including Michigan, has revoked the company's license.
Criminal investigations are being called for, and there will certainly be more investigation into "compounding" facilities.
More from the Times:
Compounding — traditionally a practice in which pharmacies mix medicine for an individual patient — is regulated by states. But in recent decades, some pharmacies began to push the legal limits, becoming mini-drug companies largely out of reach of federal authorities. Federal officials say they do not know what share of the compounding market large-scale pharmacies represent.
“Our drug experts went into some of these operations, and they said, ‘Whoa, these don’t look like ordinary pharmacies,’ ” said Gary Dykstra, who was the F.D.A.’s deputy associate commissioner for regulatory affairs in the 1990s.
Experts argue the FDA has authority over these facilities, but say the agency has not been watching them closely enough.
The symptoms of meningitis include fever, neck stiffness, nausea, vomiting, sensitivity to light, headache, and altered mental status.
The fungal meningitis associated with the outbreak is not contagious.