There have not been any reported cases so far of eye infection in eye surgery patients who received medications from the New England Compounding Pharmacy (NECC); however, other types of patients have contracted fungal meningitis. Several NECC products were recalled after patients receiving drug injections for back pain became ill. More than 400 people in 15 states developed fungal infections that have been traced to products from NECC, and more than 29 people have died.
The compounding pharmacy is supposed to ship sterile products that are free of bacteria, fungi, viruses, and contaminants. Investigators found contamination that was sometimes even visible to the naked eye. Compounding pharmacies operate in a legal gray area that includes both state and federal laws. Pharmacies are regulated by state pharmacy boards, but the FDA steps in when a significant situation arises. Sometimes the federal courts have decided the FDA overstepped its boundaries in handling problems at compounding pharmacies. The FDA is calling for new laws to make clear the federal governmental roles regarding compound pharmacies. Hearings are scheduled to determine how to prevent such outbreaks in the future.
The vast majority of patients who developed fungal meningitis after receiving NECC products were being treated for back pain. NECC also makes a heart drug called cardioplegic solution that stops the heart during heart surgery. At least one heart patient developed a fungal infection. So far, none of the NECC ophthalmic products used during eye surgery seem to have resulted in infection.
On October 31 2012, Ameridose LLC, which shares ownership with NECC, voluntarily recalled all its products after an on-site investigation by the Food and Drug Administration. The company did not receive any reports of problems, but decided to pull its products to ensure the medications fully conform with the FDA’s recommendations.
NECC produced more than 2,100 different products and the warning applies only to sterile, injectable drugs. The company also produces topical products, eye drops and other items that are exempt from the warning.