Saturday, May 25, 2013
New U.S. fears emerge over tainted compounded steroids
The FDA said full clinical information about the patients is still being gathered, but it suggested some of the problems were infections and that "at least one of these infections appears to be fungal in nature."
The steroid in question is same one - methylprednisolone acetate - that was linked to a meningitis outbreak last year that has killed some 53 people and sickened more than 700.
That outbreak was linked to the Framingham, Massachusetts-based New England Compounding Center. The FDA has since stepped up its oversight of pharmacies that compound drugs tailored to specific patient needs.
Tennessee's department of health said reports of illness came from patients in Illinois and North Carolina who received injections of preservative-free methylprednisolone acetate after December 6, 2012. It said no reports of meningitis had been received.
Illinois health officials said five patients in the state developed abscesses after receiving injections of the drug from the Logan Primary Care clinic. They said patients received the injections between January 3 and February 21 and that the cases were identified in April and May.
Health officials in North Carolina said the suspect drugs were shipped to three clinics. They began an investigation after two patients developed what have so far been identified as skin abscesses. The clinics involved are Carolina Arthritis Center, Bailey Family Practice Center and Shallote Medical Center.
The FDA said it will work closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate the reports.
"An investigation into the exact source of these adverse events is still ongoing," the FDA said, "but these cases are associated with a potentially contaminated medication."
It was not immediately clear how many patients have taken the drug, which is often given to ease back pain. It was distributed by Main Street Family Pharmacy LLC of Newbern, Tennessee.
So far, the Tennessee health department said, it is known that the products were distributed to facilities in 13 states including Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
"Health departments and facilities in these states are being notified so they can participate in response efforts," the statement said.
Investigators are reviewing the records of facilities that have received the drug to discover which patients may have been given the suspect medication.
"It is too early to know how many additional patients, if any, may be at risk," the department said. It is conducting additional laboratory work to determine the cause or causes of the illnesses.
"The first priority is to ensure all products from this pharmacy are no longer in use," the department said, adding it was examining the pharmacy's records to determine when and where the products were shipped.
State and federal health officials began an inspection of the facility on May 22. The pharmacy staff and management have cooperated, the health department said.
The pharmacy has agreed to stop compounding sterile products until the investigation is resolved. It has initiated a recall of all its sterile products, including the steroid. North Carolina officials said the pharmacy has agreed to surrender its North Carolina pharmacy license.
U.S. lawmakers are considering legislation that would give the FDA greater authority compounding 'quoted from source found herepharmacies that make sterile products without being in receipt of a prescription, and shipping them across state lines.
(Reporting by Toni Clarke in Washington; Editing by Eric Beech, Leslie Gevirtz and David Gregorio)
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