Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/cidrap/content/other/news/oct1712fungus.html
Fungal meningitis toll rises as feds raid pharmacy
Lisa Schnirring * Staff Writer
Oct 17, 2012 (CIDRAP News) ? Fourteen more cases and four more deaths were reported today in a multistate fungal meningitis outbreak linked to contaminated steroids provided by a Massachusetts pharmacy, which was raided yesterday by federal agents.
The outbreak tally now stands at 247 cases, including 19 deaths, the US Centers for Disease Control and Prevention (CDC) said in an update today. The number of affected states remained at 15, with Tennessee, Michigan, Virginia, and Indiana among the states reporting the most cases.
The infections are linked to three lots of methylprednisolone acetate from New England Compounding Center (NECC) in Framingham, Mass. The steroid drug is used in injections for back pain and joint problems. The number of peripheral joint infections linked to the outbreak remained at two.
In other developments, agents from the Food and Drug Administration (FDA) yesterday raided the NECC facility where the drugs were produced, Reuters reported. Carmen Ortiz, US attorney for Massachusetts, told Reuters that her office and law enforcement officials are investigating allegations concerning NECC.
Earlier in the outbreak investigation, officials said NECC appeared to be operating outside of its license by providing bulk medication rather than medications sold to fill individual prescriptions.
Also, US Rep. Edward Markey, D-Mass., yesterday asked the Department of Justice to investigate whether NECC has violated federal controlled-substance laws. He said in a statement that the list of recalled products from NECC includes nearly 1,000 formulations that contain substances such as cocaine, morphine, and ketamine, which require federal oversight.
Markey said the Drug Enforcement Agency (DEA) has notified his office that NECC is not registered with the DEA as a manufacturer/supplier.
Yesterday during a conference call with clinicians, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, asked doctors to check on patients who were treated with NECC drugs other than methylprednisolone acetate, because from the inspection findings so far, the FDA couldn't assure the safety of the products.
See also:
Oct 17 CDC fungal meningitis outbreak update
Oct 16 Reuters story
Oct 16 Markey statement
Oct 16 CIDRAP News story "Warnings, cases expand in fungal meningitis outbreak"
Fungal meningitis toll rises as feds raid pharmacy
Lisa Schnirring * Staff Writer
Oct 17, 2012 (CIDRAP News) ? Fourteen more cases and four more deaths were reported today in a multistate fungal meningitis outbreak linked to contaminated steroids provided by a Massachusetts pharmacy, which was raided yesterday by federal agents.
The outbreak tally now stands at 247 cases, including 19 deaths, the US Centers for Disease Control and Prevention (CDC) said in an update today. The number of affected states remained at 15, with Tennessee, Michigan, Virginia, and Indiana among the states reporting the most cases.
The infections are linked to three lots of methylprednisolone acetate from New England Compounding Center (NECC) in Framingham, Mass. The steroid drug is used in injections for back pain and joint problems. The number of peripheral joint infections linked to the outbreak remained at two.
In other developments, agents from the Food and Drug Administration (FDA) yesterday raided the NECC facility where the drugs were produced, Reuters reported. Carmen Ortiz, US attorney for Massachusetts, told Reuters that her office and law enforcement officials are investigating allegations concerning NECC.
Earlier in the outbreak investigation, officials said NECC appeared to be operating outside of its license by providing bulk medication rather than medications sold to fill individual prescriptions.
Also, US Rep. Edward Markey, D-Mass., yesterday asked the Department of Justice to investigate whether NECC has violated federal controlled-substance laws. He said in a statement that the list of recalled products from NECC includes nearly 1,000 formulations that contain substances such as cocaine, morphine, and ketamine, which require federal oversight.
Markey said the Drug Enforcement Agency (DEA) has notified his office that NECC is not registered with the DEA as a manufacturer/supplier.
Yesterday during a conference call with clinicians, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, asked doctors to check on patients who were treated with NECC drugs other than methylprednisolone acetate, because from the inspection findings so far, the FDA couldn't assure the safety of the products.
See also:
Oct 17 CDC fungal meningitis outbreak update
Oct 16 Reuters story
Oct 16 Markey statement
Oct 16 CIDRAP News story "Warnings, cases expand in fungal meningitis outbreak"