Nearly 60 people have now died as a result of a nationwide fungal meningitis outbreak linked to contaminated epidural steroid injections that were recalled late last year, and hundreds of other people face continuing effects of the infection, including a potential risk of relapsing.
According to the latest update provided by the U.S. Centers for Disease Control and Prevention (CDC) this month, at least 58 confirmed deaths and 745 fungal infections have been linked to injections mixed by the new defunct New England Compounding Center.
The number of people killed has continued to increase, with at least three new deaths added to the tally since the CDC’s May report. Federal health regulators originally predicted after the outbreak surfaced in October 2012 that the number of illnesses should have leveled off late last year, as early information suggested that the risk of fungal meningitis may only extend several weeks, as opposed to several months.
According to an April article published in the Journal of the American Medical Association (JAMA), experts now suggest that new fungal meningitis cases could continue to appear as long as a year after the outbreak first began
A report published last week in the New England Journal of Medicine now suggests that even those who previously recovered from fungal meningitis may face continuing risks. Health officials outlined a case involving an 80 year-old man who was previously treated for four and a half months with anti-fungal therapy, and then relapsed and had to be hospitalized.
The case raises questions about the adequacy of the current treatment guidelines, which already involve long and harsh antifungal treatments.
The frontline drug the CDC has suggested is the antifungal medication voriconazole, with liposomal amphotericin added when needed. However, voriconazole has been linked to a number of side effects, including hallucinations, cognitive problems, nausea, memory loss and other problems. Some patients may improve after just three months on the drugs, while others may need to take it as long as six months.
NECC faces a growing number of fungal meningitis outbreak lawsuits from victims. However, concerns exist about whether sufficient assets and insurance coverage will be available to properly compensate all of those infected. In the wake of the recall, NECC has declared bankruptcy.
Clinics Provided Patient Lists to Avoid Regulator Scrutiny
Over the months since the NECC fungal meningitis outbreak surfaced, information has highlighted how the compounding pharmacy was able to distribute its drugs so widely throughout the United States.
While compounding pharmacies are supposed to only provide drugs to local hospitals on a per-prescription basis when that drug is not otherwise available, NECC distributed more than 17,000 epidural steroid injections to medical providers in dozens of different states throughout the country.
A recent court filing suggests that at least one Nashville Clinic provided NECC with a list of patient names in order to avoid flak from regulators. However, the list was just cover, and had little bearing on which patients actually received the recalled epidural steroid injections.
In the aftermath of the outbreak, the FDA and state agencies have cracked down on compounding pharmacies nationwide, and lawmakers have put forward new legislation to address the issue, with some suggesting a new class of compounding pharmacy be created that does mass drug production. However, this proposed legislation has also raised concerns from consumer groups, who indicate that it may create a class of drug manufacturers that would not have to meet current federal drug requirements.
As the FDA increases inspection efforts at compounding pharmacies throughout the country, more and more facilities have had to recall all of their products due to problems with sterility. Most recently, on May 29, an Olympia Pharmacy drug recall was announced for all of that compounding pharmacy’s sterile drug products.