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Saturday, October 13, 2012

Fungal Meningitis Outbreak, due to tainted steroid shots - Oct 2012

Have you heard about the Fungal Meningitis Outbreak? So far, 184 people in 12 states have the rare meningitis, the CDC said on Friday. One person has an infected ankle after receiving one of the tainted steroid shots. Fourteen people have died, so far. Here is some info, as of 10-13-12... 

Updates 10-16-12... 


Framingham pharmacy raided due to meningitis outbreak


Video Link... 

 WSMV Channel 4

Video Link...

Stuart Levitz, MD: Fungal Meningitis 

Video Link...

Fungal Meningitis Q&A

WebMD Health News
Reviewed by Louise Chang, MD
Oct. 12, 2012 -- More people have been stricken with fungal meningitis that’s been linked to contaminated steroid shots sold by a compounding pharmacy in Massachusetts.
So far, 184 people in 12 states have the rare meningitis, the CDC said on Friday. One person has an infected ankle after receiving one of the steroid shots. Fourteen people have died.
Health officials expect those numbers to rise.
Before the outbreak dominated news headlines, most people had never even heard of fungal meningitis.
WebMD reached out to experts in fungal diseases to get answers to common questions about fungal meningitis.
What is meningitis?
Meningitis involves swelling and irritation of the meninges, the membranes that cover the brain and spinal cord.
In most cases, these membranes become inflamed in response to a viral or bacterial infection. But certain drugs can also cause meningitis, as can cancer.
How is fungal meningitis different than the viral or bacterial types?
“First of all it’s very rare, so we don’t have a lot of experience with it,” says Luis Ostrosky-Zeichner, MD, an infectious disease expert and director of the laboratory of mycology research at the University of Texas Health Science Center in Houston.
In fungal meningitis, fungal organisms like mold or yeast invade the cerebral spinal fluid, the clear fluid that bathes the brain and spinal cord. They also invade the brain’s blood vessels, which can cause strokes.
“With bacterial and viral meningitis, they’re relatively common and physicians know how to recognize them,” says William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, Tenn. Schaffner has treated some of the patients involved in the outbreak.
Before the current outbreak, only doctors who treated people with very low immune systems, such as patients with HIV or those who were treated with immunity-suppressing medications, would see cases of fungal meningitis.
Is fungal meningitis contagious?

No. According to the CDC, the infection can't be passed from person to person.
What are the symptoms of fungal meningitis?
They are largely the same as the symptoms of bacterial or viral meningitis: headache, fever, chills, a stiff neck, and “just feeling very badly,” Schaffner says.
But they may be slow to develop and mild.
“The speed at which people get sick is very different,” says Benjamin Park, MD, medical officer at the Mycotic Diseases Branch of the CDC.
Unlike bacterial and viral forms of meningitis, which tend to develop within hours, fungal meningitis “creeps up on you,” Park says.
“People who have gotten infected, they’ve had somewhat milder symptoms than you would expect,” says Park.
Park says nearly everyone who has gotten sick has had a headache, for example, but the headache wasn’t the worst-kind-you’ve-ever-had-in-your-life variety, as often comes with bacterial or viral meningitis.
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New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak

[UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New England Compounding Center (NECC), located at 697 Waverly Street in Framingham, MA. The Massachusetts Department of Public Health (DPH) is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on a multi-state investigation of Aspergillus meningitis among patients who received an epidural steroid injection.
As of October 4, 2012, 35 cases have been reported to CDC, including 5 deaths. The three principally implicated lots have not been distributed in Massachusetts. According to CDC, fungal meningitis, which is not transmitted from persons to person, from a potentially contaminated drug product is suspected to be the cause of the outbreak. At this time, no cases have been reported in Massachusetts. Specific information on these recalled products is located at the links provided below. Additionally, the CDC is updating information for clinicians daily at 2 pm at the following webpage:
With questions regarding case definitions of Aspergillus meningitis, please contact the DPH Epidemiology Hotline: 617-983-6800.

[Posted 10/05/2012]
AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals
ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.
Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.
BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.
RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.
Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/06/2012 - Firm Recall Press Release - NECC]
[10/05/2012 - FDA Statement - FDA]
[10/05/2012 - Q&A - FDA]

Page Last Updated: 10/11/2012
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