FDA Reports Conditions Observed at New England Compounding Center That Produced Meningitis Causing Steroid Injections

This past Friday, October 26, 2012, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC) that produced contaminated steroid injections and triggered an FDA investigation of a multistate fungal meningitis outbreak among patients who received the injections. The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions at NECC’s Framingham, Massachusetts facility.

The investigators observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment … Read the rest

Fungal Meningitis-Tainted Epidural Steroid Injections More Than Just a Pain in the Neck

Many of our clients suffer from intractable neck pain and face difficult risk-laden choices as to how to try to obtain relief from their debilitating symptoms. For example, many are given the option of undergoing surgery, which could potentially result in paralysis, or first trying a series of epidural injections. Patients are usually told that the injections may not work, but now they have something more to fear: life-threatening fungal meningitis. The latest report is that there are 119 cases of people who were infected from contaminated steroid injections (preservative-free methylprednisolone acetate (80mg/ml)). 11 people have died and many others … Read the rest