But federal officials are now warning that the risk may extend beyond the steroid shots to additional drugs that NECC compounds at its Massachusetts facility, including products used for eye operations and open-heart surgeries:
Now, several other drugs made by the company are also possible suspects in infections. A heart-transplant patient exposed to a product that is used during open-heart surgery developed a chest infection with a different fungus, Aspergillus, the Food and Drug Adminstration said. The product is a cardioplegic solution, which is chilled and poured into the opened chest to stop the heart while surgeons work on it. Such solutions have caused problems in the past, according to the F.D.A., which reported that it issued a warning letter in 2006 to a firm that had produced a solution that caused fatal infections in three heart-surgery patients. [...]
Another patient contracted meningitis after receiving a spinal injection of another one of the company’s steroid solutions, triamcinolone acetonide.
The statement from the F.D.A. also warned of possible contamination in drugs made by the company that are injected into the eye or used during eye surgery.
The FDA cautioned that the heart case was still being investigated, and officials cannot conclusively say how many additional Americans may be at risk for meningitis. But in their updated statement about the investigation, they advise health practitioners to talk to any of their patients who have taken NECC products about the symptoms for meningitis. The pharmacy has voluntarily shut down and recalled all of its products, and its pharmaceutical license has been revoked in Massachusetts and at least five other states.
Pharmacies like NECC that practice compounding are outside of the bounds of FDA safety guidelines, since the agency typically oversees drug manufacturers rather than pharmacies. The pharmaceutical industry has also lobbied to maintain their independence from FDA oversight. Health advocates have been warning about the dangers of compounded drugs for the past several decades, but efforts in Congress to strengthen the FDA’s regulatory power over compounding pharmacies in 2003 and 2007 faced too much opposition from the pharmaceutical industry to make any progress.