Over a thousand hospitals, pain clinics, cosmetic surgery centers, eye clinics and other health care providers received drugs from a Massachusetts pharmacy linked to a deadly meningitis outbreak that has taken the lives of 23 people and sickened hundreds of pain patients.
On Monday, the Food and Drug administration put a list of customers who received drugs from the New England Compounding Center’s (NECC) on its website. But several hours later the list was taken down.
FDA spokesperson Sarah Clark-Lynn told the National Pain Report the list, which was provided to the agency by NECC, contained “inaccurate data” and was being reviewed for “technical problems.” She did not know how significant the errors were or how soon they might be fixed.
Last week federal health officials confirmed that a fungus known as Exserohilum rostratum was found in unopened vials of a steroid at the NECC facility in Framingham, MA. Some 14,000 pain patients may have been injected with the steroid during epidural procedures.
“The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available,” the FDA said in a statement before the list was removed from its website. The agency said customers on the list should check their drug supplies to identify whether they have any NECC products that are part of the voluntary recall.
A dozen new cases of fungal meningitis cases were reported Monday, bringing the total to 294 in 16 states. Three additional cases of peripheral joint infection have also been linked to the tainted steroid, according to the Centers for Disease Control and Prevention.
“Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned,” the FDA said. Symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting.
The FDA is urging health care providers to follow-up with patients who were given any injectable product shipped by NECC, including an injectable ophthalmic drug used during eye surgery and a cardioplegic solution used during heart surgery. The FDA said patient follow-ups were not needed for other NECC products, such as lotions, creams, eye drops and suppositories, or for patients who used NECC products shipped before May 21, 2012. Those products were said to have “less risk.”
Meanwhile, the FDA says the extended shutdown of a sister company of NECC could further worsen shortages for certain drugs for some hospitals and healthcare providers. Ameridose has been closed since October 10 and will remain closed until November 5, while health officials inspect its facility as a precautionary measure.
“The current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems,” the FDA said. It did not identify what drugs might be affected.
Ameridose and NECC are both compounding pharmacies, which produce custom medications used by millions of Americans. There over 7,500 compounding pharmacies in the U.S. Many are small “mom and pop” operations, but larger ones – such as NECC and Ameridose — sell drugs to hospitals, clinics and physicians around the country. Compounding pharmacies are regulated by state agencies, with little oversight by the federal government.