Company Recalls All Products as Meningitis Kills Eight
New England Compounding Pharmacy, investigated in connection with a meningitis outbreak that has killed eight people and sickened 105, yesterday recalled all of its products.
The outbreak in nine U.S. states has been linked by the Food and Drug Administration to contaminated steroids used for back pain sold by the Framingham, Massachusetts-based company. Also known as New England Compounding Center, the company is cooperating with probes by the FDA and the Centers for Disease Control and Prevention, NECC said in a statement.
The steroid, methylprednisolone acetate, was shipped to facilities in 23 states from July to September, the CDC said yesterday on its website. Meningitis is an inflammation of the lining of the brain and spinal cord usually caused by an infection from a virus or bacteria.
“Epidural injections are generally very safe procedures, and complications are rare,” the Atlanta-based CDC said in the statement. “Fungal meningitis is an extremely rare cause of meningitis overall, including after epidural injections.”
The nine states where the 105 cases have shown up are Tennessee, Virginia, Florida, North Carolina, Maryland, Ohio, Indiana, Michigan and Minnesota. Tennessee has reported the most cases at 35, followed by Michigan at 21 and Virginia with 23, the CDC said.
Meningitis is an inflammation of the lining of the brain and spinal cord usually caused by an infection from a virus or bacteria. The illness linked to the outbreak isn’t contagious and can be treated with anti-fungal medication, the CDC said.
Operations Shut
The New England Compounding Center has shut operations, according to a statement. The list of recalled products from the closely held company is 71 pages long. Compounding pharmacies mix versions of medicines that generally aren’t otherwise available for sale.
Some of the patients have experienced strokes related to the fungal meningitis, the agency said. The FDA last week said it found fungal contamination in an unopened steroid vial at the pharmacy and hadn’t yet identified the type of fungus. There isn’t enough evidence to determine the original source of the outbreak, the CDC said.
The pharmacy, based in Framingham, Massachusetts, recalled 17,676 single-dose vials of the steroid, Omar Cabrera, community health education manager with the Massachusetts Department of Public Health, said in an e-mail.
The CDC has also posted a list online of the 75 health centers nationwide that received the tainted steroid vials.
To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net; Dan Hart in Washington at dahart@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Possible Meningitis Infection Linked to Second Product, FDA Says
Jared Wickerham/Getty Images
The New England Compounding Center based in Framingham, Massachusetts.
The New England Compounding Center based in Framingham, Massachusetts. Photographer: Jared Wickerham/Getty Images
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