FDA Warns of Infections Associated with a Tennessee Compounding PharmacyMay 28, 2013
The U.S. Food and Drug Administration (FDA) announced that it is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate seven adverse event reports.
The reports are associated with steroid injections that were compounded by Main Street Family Pharmacy, LLC of Newbern, Tennessee. The adverse event reports all involve patients who received preservative free methylprednisolone acetate (MPA), 880 mg/mL, by injection. Clinical information about the seven patients is pending; at least one of these infections appears to be fungal.
The FDA said that an investigation into the exact source of the adverse events is ongoing; however, the cases are associated with a potentially contaminated medication. The FDA also recommends that health care providers not administer any products labeled as sterile from the Main Street Family Pharmacy and that affected products should be quarantined until further guidance is provided. The Alabama Department of Public Health indicated that MPA, is a steroid product typically used to reduce inflammation.
Tennessee health officials said that the Main Street Family pharmacy plans on recalling all of its sterile products, which are typically injectable prescription drugs, according to The Associated Press (AP). Although officials have not confirmed product contamination, the products are being treated is if they are contaminated, Tennessee Health Commissioner John Dreyzehner said, wrote the AP.
MPA is the same drug that was the focus of last year’s deadly fungal meningitis outbreak, according to the AP. In that outbreak, some 55 people died and over 740 more were sickened after having received tainted injections from a Massachusetts compounding pharmacy.
In this outbreak, reports involve five cases in Illinois and two in North Carolina; Illinois patients received injections at the Logan Primary Care clinic in Herrin between January 3 and February 21, Illinois health officials stated, according to the AP. All of those patients suffered from skin infections in the hips and buttocks. One of the North Carolina patients appears to have a fungal infection, the CDC indicated.
Main Street Family Pharmacy is a compounding pharmacy. Compounding pharmacies manufacture custom drug formulations based on doctors' specifications, the AP explained. Since last year’s outbreak, the FDA has increased compounding pharmacy inspections nationwide; inspections have led to a number of recalls of potentially contaminated medications. Meanwhile, the pharmacies operate in a regulatory “gray area” between state and federal laws, the AP noted.
Main Street Family Pharmacy’s licenses were placed on a three-year probation in late March and the company was assessed a $25,600 fine after two inspections revealed a number of problems. According to the consent order, the 2011 inspection found out-of-date drugs on Main Street’s shelves that were being used in the manufacture of compounded drugs. Also, a technician had been working there without appropriate registration for more than four years. The November 2012 inspection revealed 109 out-of-date or deteriorated drugs on the shelves, in addition to other issues, according to the AP.