Pharmaceutical

Adverse events tied to steroid shots made by Tenn. compounding pharmacy

syringe Adverse events tied to steroid shots made by Tenn. compounding pharmacySeven cases of adverse events, including at least one involving a fungus, connected to steroid injections manufactured by a Tennessee compounding pharmacy have been reported to the Food and Drug Administration (FDA) and the Tennessee Board of Pharmacy. The FDA is recommending that health care providers not administer any products labeled as sterile from Main Street Family Pharmacy of Newbern, Tenn., and to quarantine them until further guidance is provided.

All reported adverse events occurred in patients who had received preservative-free methylprednisolone acetate (80 mg/mL) by injection, the same type of steroid shot made by New England Compounding Pharmacy (NECC) that was tied to at least 741 fungal infections, including fungal meningitis, and 55 deaths. Three lots of the NECC injection – or about 18,000 shots – were found to have been contaminated with a fungus. An estimated 14,000 people were exposed.

The multistate fungal meningitis outbreak has led to numerous recalls of sterile products from compounding pharmacies across the country, and brought into question whether oversight of these specialty pharmacies is adequate enough to prevent serious injuries.

Compounding pharmacies custom mix approved drug ingredients for patients based on a doctor’s orders. They are not regulated by the FDA, but by state pharmacy boards. Over the years, some compounding pharmacies have begun mass-producing compounded drugs and distributing them over state lines, a practice critics say opens the door for sterility issues.

An investigation into the exact source of the adverse events in patients who received steroid shots from Main Street Family Pharmacy is still ongoing. Both the FDA and the Centers for Disease Control and Prevention (CDC) are working with Tennessee authorities to thoroughly review the sterile practices at the pharmacy.

Any adverse events or quality problems experienced with any Main Street Family Pharmacy products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA