An organization of chronic pain patients warned the Food and Drug Administration about the dangers associated with epidural steroid injections months before a fatal outbreak associated with the procedure.
Thirty five people in six states have contracted a rare form of fungal meningitis linked to an injectable steroid. Five of those patients have died, according to the Centers for Disease Control and Prevention.
Health officials believe the meningitis was spread by a contaminated steroid that was injected into the patients’ spines for back pain. Investigators are also looking into the antiseptics and anesthetics used during the injections.
In a June 8 letter to the FDA, Helen Bertelli said epidural steroid injections (ESIs) were responsible for thousands of cases of arachnoiditis, a chronic and painful neuropathic disease caused by inflammation of the arachnoid membrane, which surrounds and protects the spinal cord.
Bertelli developed arachnoiditis after receiving an epidural steroid injection in 2011 for a bulging lumbar disc.
“The procedure was excruciatingly painful, and within a week I was experiencing strange new symptoms,” Bertelli wrote to FDA commissioner Margaret Hamburg.
“I now endure pain and symptoms every day, including severe stabbing pains and electric shocks, muscle cramps and fasciculations, strange sensations akin to water running down my legs or insects crawling and biting me, extreme fatigue, etc. The toll that this has taken on my family emotionally, financially and physically, is terrible,” said Bertelli, a member of Advocacy for Victims of Arachnoiditis.
The group is calling on the FDA to improve training and oversight of physicians who perform ESIs, and to warn patients about potential side-effects of spinal injections.
“Lives have been ruined by a procedure that has, at best, an equivocal track record in medical studies. Yet the procedure’s chequered history does not seem to deter doctors, some of whom have alarmingly limited training in the administration of ESIs, from performing it on patients millions of times each year,” Bertelli said.
The growing use of ESIs to relieve back pain is due, at least in part, to federal and state crackdowns on narcotic pain relievers, according to Walt Davis, the chairman of Advocacy for Victims of Arachnoiditis. Davis says pain clinics or “injection mills” are popping up in states where painkillers are becoming hard to get.
“A lot of clinics that we know about, before they will prescribe any form of pain medication for your condition, regardless of what it is, require you to go through a series of epidural steroid injections. And in a sense some pain patients are being held hostage to undergo those invasive procedures,” Davis told the National Pain Report. “I think the crackdown on the prescription pain medicines is only going to exacerbate this problem. We fear that if these crackdowns continue to get worse, we will see a huge increase in our numbers – patients with arachnoiditis.”
The steroid associated with the meningitis outbreak — methylprednisolone acetate — was recalled last week by New England Compounding Center, a specialty pharmacy in Framingham, Massachusetts. Many of the meningitis cases were linked to three pain clinics in Tennessee, where hundreds of patients received the steroid in the last few months.
Meningitis is caused by the inflammation of meninges, which are protective membranes that cover the brain and spinal cord.