Investigators have found contaminants in two more drugs released by the compounding pharmacy behind the nationwide fungal meningitis outbreak, which has killed at least 28 people and sickened hundreds more.
According to laboratory results from the FDA and the U.S. Centers for Disease Control and Prevention (CDC), bacteria was found in preservative-free injectable betamethasone and cardioplegia solutions distributed by the New England Compounding Center (NECC) in Framingham, Massachusetts.
Betamethasone is a corticosteroid that is used to relieve itching. Cardioplegia solution is used to stop the heart during surgery.
Three separate batches of betamethasone tested positive for bacteria, revealing eight different strains of microbacteria. Two additional strains of bacteria were discovered in the cardioplegia solution. Bacillus idriensis and bacillus circulans, two of the ten different kinds of bacteria discovered in the medications, are rarely reported as the cause of human disease.
The discovery of new bacterial contaminations highlights the FDA’s concern regarding the sterility of products produced at the NECC. Results from additional fungal cultures taken from the NECC are pending; however officials warn that additional microbial or fungal contaminations cannot be ruled out.
As of Nov. 1, the CDC has not received any confirmed cases of infection from bacterial contamination of organisms linked to betamethasone or cardioplegia solution; however they continue to investigate reports of potential infections from other NECC products.
Investigators blame NECC for a nationwide outbreak of fungal meningitis, saying it was caused by contamination of epidural steroid injections distributed by the compounding pharmacy throughout the summer. An estimated 14,000 people in 23 states are believed to have been injected with potentially tainted steroids.
The CDC reports 386 confirmed cases of infection, resulting in 28 deaths, across 19 states. Nine cases are confirmed as peripheral joint infections that affect the elbow, knee, shoulder and hip.
All NECC medications were recalled on October 6, and officials recommend against the use of any of the pharmacy’s drugs.
NECC faces both criminal investigations and a growing number of people who received the tainted injections are pursuing a fungal meningitis lawsuit against the pharmacy.
The outbreak is also making states take a hard look at the practices of compounding pharmacies nationwide, resulting in other closures, license revocations and fines.