Federal health officials indicate that another compounding pharmacy may have distributed contaminated steroid pain injections that could put patients at risk of suffering infections.
On May 24, the FDA issued an alert to health care providers about potential problems with preservative free methylprednisolone acetate (80 mg/mL) injections from Main Street Family Pharmacy, LLC, of Newbern, Tennessee.
Federal health officials indicate that there have been at least seven reports of adverse reactions to the pain injections, including at least one report that appears to involve fungus.
The reports raise immediate concerns about similarities to a recent fungal meningitis outbreak late last year, which has sickened more than 700 people and killed more than 50 people nationwide.
That outbreak was linked to epidural steroid injections mixed by the New England Compounding Center (NECC), which ultimately resulted in a recall of all products made by the compounding pharmacy. In the wake of the fungal meningitis outbreak, increased scrutiny has been focused on the compounding pharmacy industry industry, which has largely escaped regulation in recent years.
Like NECC, Main Street Family Pharmacy appears to have sold its drugs far and wide. Problems have been reported in North Carolina and Illinois, and the drugs were distributed to at least 11 states.
Traditionally, compounding pharmacies were designed to fill local needs by creating medications on a per patient prescription basis. However, following the NECC fungal meningitis outbreak, it became clear that many compounding pharmacies had turned into stealth drug manufacturers, distributing high volumes of medications to medical providers in multiple states, with some even employing sales representatives to visit doctor’s offices.
Main Street Family Pharmacy is currently on probation with the Tennessee Board of Pharmacy and has recalled all of its sterile products. So far the pain injection infections have only involved abscesses, and there have been no reports of fungal meningitis.
The FDA is investigating the incidents along with the U.S. Centers for Disease Control & Prevention (CDC) and the Tennessee Board of Pharmacy. The other states that received the drugs include Alabama, Arkansas, California, Florida, Kentucky, Louisiana, Mississippi, New Mexico, and South Carolina.