Saturday, October 27, 2012

FDA: Pharmacy Linked to Meningitis Outbreak Knew of Contamination

Posted By on Sat, Oct 27, 2012 at 12:00 PM

A Food and Drug Adminsitration investigation has revealed that employees of the pharmacy tied to an outbreak of fungal meningitis in 14 states —including Idaho—knew of mold and bacteria in rooms that were supposed to be sterile.

To date, the outbreak has sickened 338 people across the United States and caused 25 deaths, according to the Associated Press.

The FDA report found contamination at the New England Compounding Center exceeded the company's own safety levels and that there was no evidence that staffers at NECC corrected the problem. The FDA said it had uncovered four dozen reports of potentital contamination in company records, stretching back to January, according to the AP.

The outbreak of meningitis included at least one incident in Idaho: An Idaho male, more than 60 years old, was hospitalized with the disease.

Gem State health officials warned that as many as 39 Idaho patients may have received an epidural injection of methylprednisolone acetate contaminated with Aspergillus fumigatus.

The Idaho Division of Public Health identified a dozen idaho clinics that may have recently received injectable drugs from the NECC. Though health officials did not identify the clinics, they said they are urging clinic managers to contact patients who may have received the drugs.

The NECC's lawyer said Oct. 26 that the pharmacy "will review this report and will continue our cooperation with the FDA."

According to the FDA report, NECC began shipping vials from the lot to customers Aug. 17. That was nearly two weeks before the pharmacy received test results from an outside laboratory confirming the sterility of the drug. When FDA scientists tested the same lot this month, they found contamination in 50 vials.

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