FDA Warns of Adverse Reactions to Steroid

FDA Warns of Adverse Reactions to Steroid

file000788055222-269x300The Food and Drug Administration is once again warning physicians and patients about adverse reactions to a steroid produced by a compounding pharmacy. The agency says the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy are investigating reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy in Newbern, Tennessee.

It is not clear how many patients have taken the drug. Steroid injections are often given to relieve back pain.

The FDA is recommending that health care providers not administer any products labeled as sterile from Main Street Family Pharmacy and to quarantine them until further notice.

The Tennessee health department says the steroid was distributed to health facilities in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. The patients are located in Illinois and North Carolina. At least one of the adverse events appears to involve fungus.

“An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication,” the FDA said in a statement.

The warning is similar to reports last fall that eventually led a nationwide outbreak of fungal meningitis that killed 53 people and sickened more than 700. The outbreak was traced to a steroid – methylprednisolone acetate – produced at the New England Compounding Center in Framingham, Massachusetts. That compounding pharmacy was eventually shutdown after inspections found numerous sanitary violations, including bacteria and mold growing at the facility.

Tennessee and federal health officials began inspections of the Main Street Family Pharmacy facility on May 22. The pharmacy has agreed to stop compounding sterile products and has begun a recall of all its sterile products, including the steroid.

Congress is considering legislation that would give the FDA greater authority over compounding pharmacies, which are largely under the regulation of individual states.

Authored by: Pat Anson, Editor