FDA Warned Mass. Pharmacy Linked To Meningitis Outbreak Of 'Possible Contamination' In 2006
BALTIMORE (WJZ)-- More cases of meningitis and more deaths. WJZ has new details about the outbreak linked to tainted steroid injections: The maker of the drug was warned about the potential for disaster.
Adam May reports.
It's a growing outbreak. Almost 300 people have contracted meningitis, 23 have died from tainted steroid injections meant to relieve back pain.
A Harford County mother is among the sick.
"Flu-like symptoms, dizziness, fatigue," Patricia Pugh explained.
The drugs were made by the New England Compounding Center (NECC) in Massachusetts. A 2006 inspection of the facility by the Food and Drug Administration (FDA) warned that some of their procedures could lead to "potential microbial contamination."
"It's clear the company made a conscious decision to disregard that warning letter because only a few years later, they were engaged in the very behavior the FDA warned them about," Sheldon Bradshaw, a former counsel for the FDA who signed off on that letter, said.
There are hundreds of compounding pharmacies like the NECC in the U.S.
"There's really no oversight or regulation to make sure these compounding pharmacies are doing the right thing and maintaining safe practices," Dr. Patrick Rose, a policy analyst at the University of Maryland Center for Health and Homeland Security, said.
Earlier this year, contaminated medications were discovered at three other compounding pharmacies. The problems left some blind and one dead.
"We're putting patients' lives at risk," Rose said.
Attempts to regulate compounding pharmacies have been blocked by lobbyists for the industry. Of the thousands of compounding pharmacies in the U.S., only 162 are accredited.
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