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FDA Says More Drugs May Be Involved in Meningitis Outbreak
As a result of ongoing investigations by the FDA, the Centers for Disease Control and Prevention (CDC), and state health departments of contamination at the New England Compounding Center’s (NECC) Framingham, Mass., facility, on October 4 the FDA advised providers not to use any NECC products. The company recalled all of its products on October 6.
Now, the FDA reports that a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and has been reported to the agency. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, Aspergillus fumigatus infection has been reported in two transplant patients who were administered NECC cardioplegic solution during surgery. Investigation of these patients is ongoing, and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.
The FDA continues to evaluate these reports and has not confirmed that the three infections were, in fact, caused by an NECC product.
In the agency’s opinion, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC is of significant concern, and patients who received these products should be alerted to the potential risk of infection. So far, no cases of infection have been reported to the FDA in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but the agency believes that this class of products could present similar risks of infection.
Source: FDA, October 15, 2012.