At least 20 people now have been sickened by potentially contaminated pain shots made by a Tennessee pharmacy in a growing outbreak that echoes last year’s fungal meningitis disaster.
Most have developed abscesses. So far, none of the infections detected in patients in three states -- Illinois, North Carolina and Florida -- have led to reports of meningitis or other life-threatening illnesses.
"The majority of these person developed skin and soft-tissue infections of unclear etiology following intramuscular injection of this product," officials with the Centers for Disease Control and Prevention said in a statement issued Friday.
That makes this outbreak different from the devastating scourge of illnesses caused by the same drug -- methylprednisolone acetate, a steroid used to treat pain -- that has killed 55 people and sickened more than 740 in 20 states since last September. Those infections were tied to the now-shuttered New England Compounding Center of Framingham, Mass., a large compounding pharmacy.
The new outbreak is tied to supposedly sterile injections produced by the Main Street Family Pharmacy in Newbern, Tenn., and sent to patients in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
Last week, the Food and Drug Administration announced that the firm was recalling all lots of sterile injectable drugs after infections were detected in seven patients. Those drugs had a use-by date of Nov. 20, 2013.
In that initial announcement, FDA officials said patients developed skin abscesses after receiving the injections, including one that appeared to be fungal in nature. The patients received the shots after December 2012 and infections were diagnosed in April and May.
The Tennessee compounding pharmacy, like NECC, shipped the pain drugs across state lines. The Massachusetts outbreak led to high-profile Congressional hearings calling for an overhaul of the way the states and FDA regulate compounding pharmacies.
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 the compounding pharmacies.
Pharmacy officials say they're cooperating with the CDC and the FDA in the investigation.
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