FDA warns of infections tied to Tennessee pharmacy
The Food and Drug Administration said the problems involve seven patients who received steroid injections made at Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
The Associated Press
WASHINGTON — Health officials are investigating cases involving patients who suffered complications after being injected with potentially contaminated medications made by a Tennessee specialty pharmacy.
The Food and Drug Administration (FDA) said Friday the problems involve seven patients who received steroid injections made at Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.
Tennessee health officials said the pharmacy has agreed to recall all of its sterile products, which are generally injectable prescription drugs. Officials from the FDA and the Tennessee Department of Health have been inspecting the Newbern pharmacy since Wednesday.
Officials have not confirmed that the products are contaminated, but they are being treated as though they are, Tennessee Health Commissioner John Dreyzehner said Friday.
The injections contain methylprednisolone acetate, the same drug at the center of last year’s deadly outbreak of fungal meningitis. More than 55 people have died and more than 740 others have been sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. The steroids are typically used to treat pain.
“Based on everything we know right now, this situation does not approach the severity of the fungal infections in 2012,” Dreyzehner said.
Main Street Family Pharmacy said it supports the FDA’s recommendation that patients not be injected with the medications until the investigation is finished.
Federal authorities have identified five cases in Illinois and two in North Carolina.
All five patients from Illinois had skin infections in the hips and buttocks while at least one patient in North Carolina appears to have a fungal infection, according to the Centers for Disease Control and Prevention (CDC).
“There’s no indication at this time of meningitis or other life-threatening infection,” said Joseph Perz, an epidemiologist helping to lead the CDC investigation.
The FDA recommended doctors stop using any sterile drugs distributed by the pharmacy immediately.
Main Street Family Pharmacy is a compounding pharmacy, which means it mixes custom formulations of drugs based on doctors’ specifications.
The Tennessee Department of Health said it’s too early to tell how many people may have received the injections. According to pharmacy records, the drug was shipped to medical facilities in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
Main Street Family Pharmacy’s licenses were placed on a three-year probation on March 31 and it was assessed a $25,600 fine after two inspections found various problems.