A meningitis outbreak traced to a contaminated steroid used for back pain has killed five people and threatens thousands more, U.S. health officials said.
The New England Compounding Center, a pharmacy based in Framingham, Mass., supplied a steroid used in back injections and found to be contaminated with a fungus, Ilisa Bernstein, director of compliance for the Food and Drug Administration’s Center for Drug Evaluation and Research, said yesterday on a conference call. The steroid, methylprednisolone acetate, was shipped to facilities in 23 states from July to September, according to the Centers for Disease Control and Prevention. The pharmacy recalled three lots of the drug, which the Associated Press reported contained 17,676 single-dose vials.
Meningitis is an inflammation of the lining of the brain and spinal cord usually caused by an infection from a virus or bacteria. Thirty-five people in six states -- Florida, Indiana, North Carolina, Tennessee and Virginia -- have contracted fungal meningitis and five have died after receiving steroid injections in their backs, the CDC said on its website. The fungal illness is not contagious and can be treated with medication, the Atlanta-based agency said.
“Out of an abundance of caution, we advise all health-care practitioners not to use any product” manufactured by the Massachusetts pharmacy, Bernstein said on the call.
The company is a compounding pharmacy, which means it custom mixes versions of medications in ways that generally aren’t otherwise available for sale.
“As previously announced, we have voluntarily suspended operations while we assist authorities in this investigation,” the company said in a statement. “The fatalities and illnesses confirmed today by the CDC and FDA are tragic. The thoughts and prayers of everyone employed by NECC are with those who have been affected.”
No comments:
Post a Comment