Thousands of individuals who received recalled epidural steroid injections earlier this year may face an ongoing risk of “hidden” fungal infections caused by the contaminated shots, federal health officials are warning.
According to the latest numbers provided by the U.S. Centers for Disease Control and Prevent (CDC), more than 600 confirmed infections have been identified as part of a nationwide fungal meningitis outbreak linked to medications mixed by the New England Compounding Center (NECC), including at least 40 deaths.
These reports involve confirmed cases of fungal meningitis, spinal infections and peripheral joint infections among individuals who received contaminated epidural steroid injections.
In the latest issue of the New England Journal of Medicine, research suggests that an even larger number of individuals who received the injections may have infections that they are unaware of. In response to the findings, the U.S. Centers for Disease Control and Prevention (CDC) has posted an update warning about the potential hidden fungal infections.
Of the 14,000 people estimated to have received contaminated methylprednisolone acetate injections before they were recalled, data suggests that more than 50% could have a localized spinal or paraspinal infection, such as an epidural abscess, phlegmon, arachnoiditis, discitis, or vertebral osteomyelitis.
MRIs Used to Find Fungal Infections from Recalled Drugs
The infections were detected through the use of Magnetic Resonance Imaging (MRI) on patients who had received the contaminated injections. The CDC is recommending MRI scans for any patients that received the shots and are showing persistent symptoms of a possible infection. because they can be difficult to detect.
The warning comes as the FDA struggles to determine what, if any, new regulatory action should be taken to prevent a similar outbreak and to rein in what many see as an out-of-control compounding pharmacy industry.
Compounding pharmacies are supposed to make specialty drugs tailored for individual, local patients who cannot get what they need through a large drug supplier on a per-patient basis. But some appear to have been operating as stealth drug manufacturers.
NECC distributed the epidural steroid injections with no individual prescriptions to hospitals nationwide, even going as far as sending sales representatives to hospitals to push its own line of pain drugs which had never been through the same FDA approval process as real drug manufacturers. The company has since lost its compounding pharmacy license and faces a growing number of fungal meningitis lawsuits, as well as likely criminal charges.
However, state and federal experts suspect the problem is not limited to NECC and several states are trying to crack down on compounding pharmacies on their own. The FDA and states are currently discussing by what means compounding pharmacies could be better regulated, since many previous compounding pharmacy regulations were shot down by a Supreme Court decision years ago and Congress never replaced or updated them.
FDA Plan Would Create Two-Tier Compounding Regulations
One potential idea being floated by the FDA Wednesday would split compounding pharmacies into those that were more traditional, supplying drugs on a per-patient and per-prescription basis, and non-traditional, which would bring compounding pharmacies who had been acting like drug manufacturers under drug manufacturing laws.
Currently, the FDA has to get a court order to look at the books of a compounding pharmacy suspected of distributing drugs en masse. And neither the agency nor the states have any idea how widespread mass compounding has become.
But critics say the FDA doesn’t need any more authority to regulate compounding pharmacies, saying the agency has that power right now. Some also object to what appears to be rewarding compounding pharmacies that became illegal businesses by legitimizing them instead of punishing them for putting the public’s health at risk.
The consumer watchdog group Public Citizen warned that the proposal put forward by FDA Commissioner Margaret Hamburg “would weaken laws governing drug manufacturing by legalizing an entirely new tier of drug manufacturers that would be subject to substandard requirements for ensuring the efficacy, safety, quality and adequate labeling of drugs.”
“The FDA’s proposal for oversight of ‘non-traditional’ compounding, if implemented, would decriminalize what is now illegal drug manufacturing conducted under the guise of pharmacy compounding, and ensure the continuing occurrence of serious disease outbreaks caused by tainted drugs in the future,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a press release. “The proposal would legitimize current abuses to the system and put the public at risk.”
The CDC says the public was at even more risk than people realize due to the fungal meningitis outbreak, which could have been much worse if not for quick action by state and federal health care officials. Smaller outbreaks of fungal meningitis due to spinal injections had fatality rates of 40 to 50 percent, meaning there could have been as many as 7,000 dead from NECC’s contaminated drugs in a worst-case, or even average-case scenario.