The number of deaths linked to a rare fungal meningitis outbreak rose to 20 on Thursday as health officials announced new evidence tying the illnesses to tainted steroid medication.
According to the Centers for Disease Control and Prevention and the Food and Drug Administration, scientists have confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate that were packaged by New England Compounding Center in Framingham, Mass.
The vials belonged to one of three lots of medicine that NECC had produced. The company has since been shut down.
"The laboratory confirmation further links steroid injections from these lots from NECC to the multi-state outbreak of fungal meningitis and joint infections," the FDA announced in a news release. "Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues."
CDC and state health departments estimate that approximately 14,000 patients were exposed to the tainted medication. The injections were primarily given as epidural injections to older patients.
The outbreak has focused intense scrutiny on the pharmaceutical compounding industry, which is not regulated by federal authorities. Instead, oversight falls to individual states.
In an article published online Thursday in the Annals of Internal Medicine, Dr. John R. Perfect wrote that physicians and healthcare providers should be prepared to observe patients for a period of months following injection with the tainted medication, as the illness can be extremely slow to develop.
Perfect was among a group of physicians who treated patients who became ill after being injected with the same compounded drug in 2002.
"We learned, or thought we learned, several important lessons," Perfect wrote of that earlier outbreak. "Compounding of preservative-free corticosteroids requires meticulous sterility to ensure lack of fungal contamination; in the absence of that level of sterility and in an environment of highly concentrated steroids, fungi grow aggressively."
According to the Centers for Disease Control and Prevention and the Food and Drug Administration, scientists have confirmed the presence of a fungus known as Exserohilum rostratum in unopened vials of preservative-free methylprednisolone acetate that were packaged by New England Compounding Center in Framingham, Mass.
The vials belonged to one of three lots of medicine that NECC had produced. The company has since been shut down.
"The laboratory confirmation further links steroid injections from these lots from NECC to the multi-state outbreak of fungal meningitis and joint infections," the FDA announced in a news release. "Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues."
CDC and state health departments estimate that approximately 14,000 patients were exposed to the tainted medication. The injections were primarily given as epidural injections to older patients.
The outbreak has focused intense scrutiny on the pharmaceutical compounding industry, which is not regulated by federal authorities. Instead, oversight falls to individual states.
In an article published online Thursday in the Annals of Internal Medicine, Dr. John R. Perfect wrote that physicians and healthcare providers should be prepared to observe patients for a period of months following injection with the tainted medication, as the illness can be extremely slow to develop.
Perfect was among a group of physicians who treated patients who became ill after being injected with the same compounded drug in 2002.
"We learned, or thought we learned, several important lessons," Perfect wrote of that earlier outbreak. "Compounding of preservative-free corticosteroids requires meticulous sterility to ensure lack of fungal contamination; in the absence of that level of sterility and in an environment of highly concentrated steroids, fungi grow aggressively."
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