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Friday, 24 May 2013

FDA warns pharma Tennessee tied infection


WASHINGTON (AP) - Public health officials are investigating several reported complications with potentially contaminated drugs made by a specialty pharmacy Tennessee.

The Food and Drug Administration said Friday that the investigation involved seven reports of patients who received steroid injections of Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

Injection contains methylprednisolone acetate, the same drug at the center of last year's deadly outbreak of fungal meningitis. More than 55 people were killed and more than 740 others have been sick after receiving contaminated injections of compounding pharmacies Massachusetts. Steroids are commonly used to treat pain.

The FDA said at least one of the seven cases seems to be a fungal infection. The government recommends doctors stop using sterile drugs distributed by pharmacies.

Main Street Family Pharmacy is a compounding pharmacy, which means a mixture of custom formulations based medicine physician specifications. Compounding pharmacies have long operated in a legal gray area between state and federal regulations. Since the outbreak last year, the FDA has increased inspections of compounding pharmacies across the country, triggering a potentially contaminated drug given state.

A woman contacted at Main Street Family Pharmacy on Friday afternoon could not immediately comment.

In a separate announcement, the North Carolina Department of Health said it is investigating two cases of complications reported by patients who received injections at a clinic in Greenville. State officials said the problems reported to date involves skin infections. There were no reports of meningitis, stroke or death, according to state broadcaster.

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