Tuesday, October 16, 2012

10/16/12 Steroid Injection Recall News: New Drugs (Cardioplegic Solution) Tied to Meningitis Outbreak


From the FDA, more worrisome news as of yesterday: 

ISSUE: As a result of the ongoing investigation of New England Compounding Center (NECC), a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. 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, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. 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.


From the WSJ: 


The Food and Drug Administration said Monday that two additional drugs may be linked to the multistate fungal meningitis outbreak stemming from steroid injections made by a compounding pharmacy in Massachusetts.
The FDA said that a cooling solution made by NECC called cardioplegia, used in heart surgery, and a second injected steroid called triamcinolone acetonide now may be involved in the outbreak. That finding is based on its investigation, along with inquiries by the Centers for Disease Control and Prevention and by state health departments.
The triamcinolone injection made by the New England Compounding Center was linked to one case of possible meningitis