FDA warns of infections tied to Tenn. pharmacy

Posted: Published on May 25th, 2013

This post was added by Dr P. Richardson

By Maggie Fox, Senior Writer, NBC News

Health officials fear they have another outbreak of infections linked to pain injections -- this one because at least seven people in two states developed abscesses after getting injections of steroid drugs. They're all linked to a single pharmacy: Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

Tennessee state officials say the facility distributed the products to 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

"Fortunately, we are aware of no serious events like meningitis, stroke or death in association with this cluster, but still our hearts go out to those affected by this event," Tennessee state health commissioner Dr. John Dreyzehner told reporters in a telephone briefing.

"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 Food and Drug Administration said in a statement.

"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports," it added.

"Complications identified thus far are skin abscesses," the North Carolina Department of Health and Human Services said in a statement. "Health officials have not had any reports of meningitis, stroke, or death." North Carolina officials are investigating the cases of two patients injected with steroids from the Tennessee pharmacy.

The injections contain 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 developed infections after receiving contaminated injections from the New England Compounding Center in Massachusetts.

The FDA says that at least one of the seven cases appears to be a fungal infection. The government recommends doctors stop using any sterile drugs distributed by the pharmacy.

Illinois officials said they were checking on five patients who developed abcesses after getting the injections. They were given the steroids between January 3 and February 21, and diagnosed in April and May.

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FDA warns of infections tied to Tenn. pharmacy

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