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FDA warns of infections tied to Tenn. pharmacy

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.

Tennessee officials say they are acting to track down anyone who may have received an injection from the pharmacy. "We are double checking and triple-checking to ensure that we have a good understanding of which products went to which facilities in which states," said Dr. Marion Kainer of Tennessee's state health department.

Dreyzehner said it's not clear whether any of the steroid injections from the pharmacy are actually contaminated. "We are acting as if they are," he said.

"Main Street Family Pharmacy, LLC, was licensed by the Tennessee Board of Pharmacy in 1985. It is currently on probation as a result of a recent inspection," the Tennessee Department of Health said. Officials said the problems had to do with drugs that were past their use-by date, as well as at least one unregistered technician.

The FDA has asked Congress to pass legislation giving it more power to regulate large-scale compounding pharmacies that ship products in bulk. The House and Senate both have measures in the works and leaders say they hope to have a bill ready soon.

FDA officials have repeatedly warned that it's a matter of when, not if, a new outbreak will occur because of poor regulation of compounding pharmacies.

Traditionally, compounding pharmacies mixed up drugs on a patient by patient basis, following a doctor's prescription. But in part because there's so much demand for specialty formulations, and because it's a lucrative business, large-scale compounders now mix up giant batches and ship them to hospitals and clinics ahead of anticipated need. Many operate across state lines.

"There’s no regulation that fits this new industry that’s grown up," FDA's Dr. Janet Woodcock told a House committee hearing on the issue on Thursday.

Woodcock says the FDA is often powerless to police these new, large compounders until there is a problem. Some members of Congress and consumer groups have accused the FDA of failing to do its job.

Since the outbreak linked to the Massachusetts pharmacy, FDA and state officials have stepped up inspections of compounding pharmacies, and found many operating with unsterile conditions.

Main Street Family Pharmacy said it was cooperating with the investigation. "As the FDA reported, an investigation into the exact source of the potential adverse effects from methylprednisolone acetate is inconclusive and ongoing. The company is fully supportive and compliant with the FDA’s recommendation that patients not be administered this compounded medicine until the investigation is complete," the company said in a statement.

 

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