Monday, December 17, 2012

Two More Drugs May Be Part of Fungal Meningitis Outbreak: FDA


By: Irvin Jackson | Published: October 16th, 2012
Federal health experts are warning about the potential risk of contamination with two other drugs distributed by the compounding pharmacy at the center of a recent fungal meningitis outbreak, which has killed at least 15 people and sickened more than 200 others throughout the United States. 
The FDA issued a warning on October 15, indicating that patients who have been given the injectable steroid triamcinolone acetonide or who received cardioplegic solution during surgery should also be notified to see their doctor to ensure they do not have fungal meningitis.
The agency believes that vials of the two drugs that were distributed by New England Compounding Center (NECC) may also be contaminated.
Until now, investigators believed the outbreak to be restricted to the epidural steroid injection methylprednisolone acetate, which was recalled in early October.
The FDA says that cases of possible fungal meningitis have also been identified among users of the other two NECC drugs. Triamcinolone acetonide is another injection steroid product, and cardioplegic solution is used to paralyze the heart during heart surgery to prevent injury. The cases are still under investigation.
Although the focus of the outbreak was on the epidural steroid injections, NECC recalled all drugs mixed by the pharmacy on October 6, just two days after recalling the epidural steroid injection recall. The company has previously indicated that there are no problems with other drugs, but removed all of their products from the market amid the investigation.
The compounding pharmacy shut down as the scope of the investigation widened and after the FDA found 50 sealed vials at the facility that were contaminated. Earlier this week, Tennessee revoked the company’s license to work in that state.
Tennessee has been hardest hit by the outbreak, with six deaths and 53 illnesses. Michigan is a close second with three deaths and 46 sick. So far, 15 states have reported illnesses. In addition to Tennessee and Michigan, there have also been fungal meningitis infections reported in Florida, Idaho, Illinois, Indiana, Maryland, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Texas and Virginia.
Before the FDA announced two new drugs possibly being linked to the outbreak, the U.S. Centers for Disease Control and Prevention (CDC) estimated that 14,000 people had been exposed to the drugs via epidural steroid injections. It is unclear how the addition of more suspect drugs will increase that number.
The first known first fungal meningitis outbreak lawsuit was filed late last week, by a Minnesota woman who is seeking class action status for everyone who potentially received tainted injections in that state. She has shown symptoms of fungal meningitis, but is awaiting lab test confirmation.
Source found here

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