May 25, 2013
Tennessee Pharmacy Steroid Injections Recalled After Complications Arise
redOrbit Staff & Wire Reports - Your Universe Online
Federal and state health officials are warning health care providers against using anti-inflammatory steroid injections from Main Street Family Pharmacy in Newbern, Tennessee after seven patients developed abscesses following treatment with the substance.According to CNN´s Michael Martinez, the compounding pharmacy has been placed on probation and voluntarily recalled the steroid — preservative free methylprednisolone acetate (80 mg/mL) or MPA — in at least 11 states. The move comes after five patients in Illinois and two more in North Carolina developed abscesses following injection.
The Tennessee Department of Health, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are all investigating Main Street Family Pharmacy, and state health officials report that the facility is “currently on probation” following a recent inspection, Martinez said. Authorities told CNN that no cases of meningitis or other life-threatening infections had been reported.
“Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided,” the agency said in a statement Friday. “An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication.”
“To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus,” they added. “As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.”
All five of the Illinois patients that developed abscesses received their MPA injections at the Logan Primary Care clinic in Herrin between January 3 and February 21, health officials told CNN. The two North Carolina patients reportedly received their injections at a clinic in Greenville, and Illinois authorities added that one of those cases “indicates a fungal infection as the cause of an abscess.”
“North Carolina authorities said skin abscesses have been the complications identified so far,” Martinez said. In a statement, North Carolina Board of Pharmacy and the North Carolina Department of Health and Human Services said that Main Street Family Pharmacy had “agreed to voluntary surrender” its pharmacy license in that state.
In addition to Illinois and Carolina, the Tennessee compounding pharmacy distributed the MPA injections to Alabama, Arkansas, California, Florida, Kentucky, Louisiana, Mississippi, New Mexico, and South Carolina. The FDA is asking health care workers in medical professionals in those states to “report adverse events or quality problems experienced with the use of any Main Street products.”