FDA warns higher-risk patients amid meningitis outbreak
POSTED: Thursday, October 25, 2012 - 12:30pm
UPDATED: Thursday, October 25, 2012 - 12:34pm
CNN — The Food and Drug Administration has listed on its website more than 3,000 medical facilities across the nation that have received potentially tainted products and urged that patients who received higher-risk products be alerted.
Of the facilities identified as having received products from the New England Compounding Center, nearly half (1,279) received medications that the FDA considers at higher risk of causing an infection.
The warning covers medications shipped from the company since May 21.
Tainted medications from the compounding center have been blamed for an outbreak of fungal meningitis that has caused 24 deaths and 317 cases of illness.
In a posting late Tuesday, the drug agency urged the facilities to warn patients who may have received the higher-risk products to be alert to the signs of fungal meningitis, which include headache and fever.
The agency said it did not know how many patients may have received the compounding center products in general or how many may have received the high-risk medications.
The listing was posted hours after federal authorities launched a criminal investigation into the company's safety practices.
In addition, the Massachusetts Board of Registration in Pharmacy has voted to revoke permanently the New England Compounding Center's license to operate in the state as well as the licenses of the company's three principal pharmacists.
Those moves were announced in the wake of a damning nine-page report released Tuesday by the pharmacy board, which is part of the state's Department of Public Health.
Public Health investigators, working with their counterparts at the FDA, "identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health at risk," the report said.
According to preliminary findings, the compounding center did not follow proper sterilization procedures and distributed its products without knowing whether they had passed sterility tests.
In addition, it distributed vials containing a steroid that was contaminated with "visible black particulate matter" later identified as fungus.
"It is now clear that the New England Compounding Center violated state law and endangered the health of countless patients," U.S. Rep. Edward J. Markey, D-Massachusetts, said Tuesday in a statement.
The senior member of the Energy and Commerce Committee, which has jurisdiction over the FDA, vowed to introduce legislation to improve safety of drugs made by compounding pharmacies.
Massachusetts Gov. Deval Patrick said Tuesday that the state will begin making unannounced inspections of pharmacies that prepare injectable medications and require that they submit annual reports detailing what they produce, how much of it and where it is distributed.
The incident began unfolding September 24, when the department was notified about a cluster of six rare fungal meningitis cases in Tennessee. The patients shared several risk factors, including having received an epidural injection of a steroid -- methylprednisolone acetate 80 mg/ml preservative free -- that had been compounded at the New England Compounding Center in Framingham, Massachusetts.
The department soon learned that the suspect product had been distributed to more than 14,000 patients in 23 states.
The Department of Public Health has asked two other companies -- Ameridose and Alaunus Pharmaceutical -- to cease all pharmacy operations based on their shared ownership and leadership with New England Compounding Center.
"NECC's transparency in dealing with the board since inception in 1998 demonstrates its good faith intention to operate in compliance with the requirements of its license," said Paul Cirel, a Boston-based lawyer representing the compounder, in a statement on Tuesday.
"Furthermore, the company's intention and best efforts at compliance are equally applicable in every other state in which it has been licensed."