Monday, October 15, 2012

Meningitis outbreak: TN jerks firm's license as more of its drugs are linked to fungi


The Tennessee Board of Pharmacy today accepted the voluntary surrender of New England Compounding Center’s license to do business in the state, while federal officials said more of the firm’s drugs have been linked to cases of fungal meningitis.
The newly identified drugs are used in epidural injections and in heart surgery. The U.S. Food and Drug Administration said it is also looking into drugs produced by the compounding lab that are injected into the eye.
The FDA said a different type of steroid medicine called triamcinolone acetonide, which was also administered through an epidural injection, has now been linked to a case of fungal meningitis. The cases of meningitis identified to date have been associated with methylprednisolone acetate, a similar steroid injectable product.
In addition, two transplant patients with Aspergillus fumigatus infection who were administered cardioplegic solution from New England Compounding during surgery have been reported, the FDA said, noting that there could be other explanations for their Aspergillus infections as the investigation unfolds. Cardioplegic solution is used to paralyze cardiac muscles during open heart surgery to prevent injury to the heart.
“FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public,” the agency said. “FDA has not confirmed that these three infections were, in fact, caused by an NECC product.”
Steroid medicine produced by the Massachusetts-based company has sickened 53 Tennesseans, killing six of them. But no new illnesses or deaths were reported today by the Tennessee Department of Health.
Although Tennessee penalized the compounding lab later than four other states, its action is more severe, said John Smith, chief counsel for the state Department of Health.
Several other states had suspended the license of New England Compounding, a temporary measure, but Tennessee’s action is permanent, Smith said.
Continue read here

No comments: