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Fears compounding over deadly US meningitis outbreak

US health authorities have widened an investigation into a deadly meningitis outbreak linked to a drug compounding operation. In a case that has raised concerns about the safety of the largely unregulated drug compounding industry, 15 people have died and more than 200 have fallen ill across 15 states after taking medicines prepared by the New England Compounding Center (NECC).

05 Nov 2012

US health authorities have widened an investigation into a deadly meningitis outbreak linked to a drug compounding operation.

In a case that has raised concerns about the safety of the largely unregulated drug compounding industry, 15 people have died and more than 200 have fallen ill across 15 states after taking medicines prepared by the New England Compounding Center (NECC).

The Food and Drug Administration and the Centers for Disease Control and Prevention estimate that about 14,000 people in 23 states may have been exposed to fungal meningitis after being administered the steroid methylprednisolone prepared by the Massachusetts-based company.

Authorities are also investigating whether two other medications prepared by the NECC, the steroid triamcinolone and an unidentified heart medication, are the source of three more fungal meningitis cases.

The FDA has warned doctors not to use any of the NECC’s products, and the company has recalled the steroid linked to the original outbreak and suspended its operations.

The incident has prompted US legislators to consider changes to strengthen federal drug safety regulations.

There is confusion about what authority the FDA has to regulate drug compounding, in which pharmacies alter or recombine approved medications to meet the specific needs of doctors and their patients.

Pharmacists have a legal exemption to prepare customised doses of medicine for individual patients, but some politicians are concerned the NECC operated far beyond this limited mandate and instead functioned like a manufacturer, preparing more than 17,000 vials of compound steroids for patients in 76 facilities across 23 states.

AR


Published: 05 Nov 2012