Friday, October 19, 2012

Would You Like Some Fungus with Your Spinal Injection?

Health officials are hunting for the source of a meningitis outbreak among dozens of people who received steroid injections to treat back pain.

So far, 169 people have fallen ill with fungal meningitis and 20 have died after receiving shots in the spine. Health officials expect the case count to rise, warning that hundreds, if not thousands of patients who received epidural steroid injections could be at risk. The fungus, Aspergillus, causing illness may have contaminated the steroid injections at some point in the manufacturing process, but investigators are still searching for the cause.

Officials say the drug associated with the outbreak is methylprednisolone acetate, made by New England Compounding Center (NECC) in Framingham, Mass. On Sept. 25 NECC voluntarily recalled three lots of the drug, and on Oct. 3 the company expanded the recall to include all lots of the medication, as well as other injectable drugs administered directly into the spinal fluid.
Health officials are also testing other medications used with the steroid injections, including lidocaine injections and antiseptic agents, as potential sources of contamination.

On Thursday, however, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) ramped up warnings, recommending that doctors and health care personnel remove from their inventories all methylprednisolone products from NECC, and contact any patient who has received an injection of the drug since July. There is no evidence that more than three lots of the medication may have been contaminated, but Ilisa Bernstein, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, told reporters during a briefing that “out of an abundance of caution, we are urging physicians and health care personnel at clinics and hospitals to check their drug supply for all product purchased from NECC and discontinue use at this time.”

Florida health officials said Friday there are 17 confirmed cases of fungal meningitis due to contaminated steroids administered for back pain.
Four new cases were announced: a woman from Escambia County, and three Marion County women.
Three of the 17 people with meningitis have died, and across the U.S., the death toll has risen to 20 people. It's part of a national outbreak due to tainted steroids sold to health clinics in 16 states by a Massachusetts compounding pharmacy.
Meningitis is caused by the inflammation of protective membranes covering the brain and spinal cord. Fungal meningitis is not contagious; health officials said that the condition was caused by tainted steroid spinal injections from the New England Compounding Center.
Dr. John Armstrong, Florida's surgeon general and secretary of health said that Floridians should not be worried about any NECC medication in any pharmacy.
"We want to reassure the people of Florida that no community pharmacy has had any NECC medications," he said. "This includes the top 10 pharmacy chains."
Residents with questions or concerns can call a meningitis hotline at 866-523-7339. Armstrong said more than 1,000 people have called so far.
Eight facilities in Florida received the contaminated lots of steroids but only six used them. Of the 1,038 people in Florida who received the injections, all but two have been contacted by state health officials.
The number of people exposed to contaminated steroids linked to a Framingham compounding pharmacy grew to 14,000 Thursday, and health officials said patients who got joint injections also may have been infected.

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1 comment:

Neurosurgery in India said...

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