Friday, May 31, 2013

IMPORTANT: CDC calls illnesses associated with TN compounder an outbreak--17 states now included

The U.S. Centers for Disease Control and Prevention on Thursday classified illnesses associated with medicines made by a compounding pharmacy in Newbern, Tenn., as an outbreak.
The CDC launched a website to offer guidance on suspected infections among people who received preservative-free methylprednisolone acetate (MPA) 80mg/mL in 10mL vials produced by the Main Street Family Pharmacy. This is the same steroid medicine formerly made by New England Compounding Center linked to last year’s fungal meningitis outbreak.
“The majority of these persons developed skin and soft tissue infections of unclear etiology following intramuscular injection of this product,” the CDC said. “Additional clinical information is being gathered. To date, no reports of meningitis or other life-threatening infections have been reported.”

Twenty illnesses have been reported in Illinois, North Carolina and Florida. The pharmacy also sent products to seven clinics in Tennessee, but no illnesses have been reported in this state.
The U.S. Food and Drug Administration on Friday announced a recall of all sterile products made by Main Street Family Pharmacy. The suspect medicine was distributed to 17 states — New York, North Carolina, South Carolina, Florida, Alabama, Tennessee, Kentucky, Mississippi, Illinois, Arkansas, Louisiana, Kansas, Florida, Texas, New Mexico, Montana and California.
The pharmacy issued an updated statement Thursday through its crisis communicator, Joe M. Grillo, a Boston-based public relations specialist.
“Since this matter surfaced, Main Street Family Pharmacy has done everything in its power to ensure that all potentially affected compounded medicines are recalled and no longer used by consumers or healthcare providers,” Grillo said. “In addition to the recall, our efforts have also included comprehensive, aggressive outreach to everyone who could be affected. We continue to fully cooperate with state boards of pharmacies, the FDA and CDC to protect patients and resolve any lingering concerns.”
People are still getting sick from last year’s outbreak, which has resulted in 741 illnesses with 55 deaths. The most serious illnesses occurred when methylprednisolone acetate produced by New England Compounding Center was injected into the spinal area as apain treatment and patients became infected with fungal meningitis.
The outbreak spawned a new form of the disease that physicians and scientists are still trying to fully understand. A letter to The New England Journal of Medicine published online this week related the case of one patient who was treated with antifungal medications for months but relapsed after treatment was stopped.
Jay Campbell, executive director of the North Carolina Pharmacy Board, said Thursday that Main Street voluntarily surrendered its license to operate as a pharmacy in that state at the same time that the recall was implemented.
“It’s not an everyday event,” Campbell said when asked if the surrender of a license was a routine matter.
North Carolina health officials have reported that two patients developed complications following an injection with a Main Street steroid.
The complications reported among North Carolina patients are skin abscesses.
Main Street shipped the steroid, methylprednisolone acetate, to three North Carolina health facilities.
Contact Tom Wilemon at or 615-726-5961. Contact Walter F. Roche Jr. or 615-259-8086.
quoted from here

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