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FDA: 7 Infections Tied To Steroid Injections From Tenn. Compounding Pharmacy

7:44 PM, May 25, 2013   |    comments
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CBS News -- Federal health officials are investigating reports of complications caused by possibly contaminated medications made by a Tennessee specialty pharmacy.

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

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 over 740 others have been sickened after receiving contaminated injections from a Massachusetts compounding pharmacy, the New England Compounding Center. The steroids are usually used to treat pain and reduce inflammation.

The FDA said in a statement 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 and quarantine them until further notice.

To date, there have been no reports of meningitis or life-threatening infections, the State of Tennessee Department of Health said in a press release.

The department added the patients were in Illinois and North Carolina, and received the injections after Dec. 6, 2012.

Health care facilities in at least 13 states received the products including: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

"The pharmacy staff and management have been cooperative," state regulators added in the press release.

The Dyersburg State Gazette reported in April that Main Street Family Pharmacy had been placed on probation for two years by the Tennessee State Board of Pharmacy beginning in March. Last November, the Board had inspected the facility and found violations related to drug compounding, expired medications, and outdated prescription orders, the Tenn. paper reported.

CBS News requested comment from the pharmacy but phone calls were not returned.

Main Street Family Pharmacy is a compounding pharmacy, which means it mixes custom formulations of drugs based on doctors' specifications.

Compounding pharmacies have long operated in a legal gray area between state and federal regulations. Since last year's outbreak, the FDA has stepped up inspections of compounding pharmacies across the country, triggering several national recalls of potentially contaminated medications.

Drug compounders have been overseen by state pharmacy boards, with regulations varying widely depending on the state. Over the last 20 years some compounding pharmacies have grown into larger business, operating more like manufacturers by shipping thousands of doses of drugs across state lines. The FDA has occasionally tried to assert its authority over these operations, though it has repeatedly been challenged in court by pharmacy owners.

Legislation moving through Congress would give the FDA direct oversight over these so-called compounding manufacturers, with the aim of preventing future national outbreaks tied to compounded medications. While Republicans and Democrats in the Senate have coalesced around a bill, the House has not reached any such agreement.

CBS News

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