By John Gever, Deputy Managing Editor, MedPage Today
SILVER SPRING, Md. — Seven patients injected with corticosteroids from a Tennessee compounding pharmacy have fallen ill, including at least one case of apparent fungal infection, the FDA said.
The agency said it was working with the CDC and authorities in Tennessee to investigate the adverse events, linked to methylprednisolone acetate compounded by Main Street Family Pharmacy in Newbern, Tenn.
“Clinical information about these patients is pending; at least one of these infections appears to be fungal in nature,” an FDA statement said.
“Out of an abundance of caution, the FDA recommends that healthcare providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided,” the agency said.
The statement echoed reports last fall that eventually ballooned into a nationwide outbreak of fungal meningitis traced to a compounding pharmacy in Framingham, Mass., that had distributed injectable methylprednisolone. Ironically, those initial reports were also centered in Tennessee.
The outbreak prompted the FDA to initiate surprise inspections of compounding pharmacies across the country, forcing numerous recalls and facility shutdowns.