Several prominent doctors are raising questions about the safety of epidural steroid injections, after tainted shots sparked a fungal meningitis outbreak that sickened hundreds and killed dozens of patients, resulting in new laws and regulations against the compounding pharmacy industry.
Drs. Honorio T. Benson, Marc A. Huntoon and James P. Rathmell published an editorial in The Journal of the American Medical Association (JAMA) on March 30, calling for more research into the effectiveness of the injections, used to relieve chronic back pain, and whether any reductions patients experience in pain are worth the potential health risks.
The call to action comes nearly three years after a fungal meningitis outbreak linked to epidural steroid injections compounded by the New England Compounding Center (NECC) killed more than 60 people and sickened hundreds more throughout the U.S.
More than 17,000 vials of the contaminated steroid were distributed to hospitals and other medical centers nationwide. More than 14,000 patients received the shot.
The doctors warn that potential contaminants are not the only risks. However, they also note that the injections are generally considered safe.
“Published reports seem to demonstrate the safety of epidural steroid injections, with only mild and transient adverse effects, in large clinical trials. However, rare occurrences of catastrophic central nervous system injuries, including paraplegia, quadriplegia, medullary infarct, cerebellar infarct, and death after epidural steroid injections, have been reported as isolated cases,” the researchers warned. “Epidural injections in the cervical epidural space, especially when performed while the patient is under sedation and without appropriate precautionary steps…have resulted in spinal cord injury.”
A working group of specialists, coordinated by the FDA’s Safe Use Initiative, recently published a number of epidural steroid injection safety recommendations. They include a recommendation that all such injections be performed using imaging guidance and a test dose of contrast medium to see where the injections will go and specific details on where the injections should be given.
Outbreak Led To Major Compounding Pharmacy Changes
The NECC fungal meningitis had wide repercussions, including new laws and regulations on how compounding pharmacies are operated, as well as a number of lawsuits agaisnt NECC.
The biggest change following the outbreak was the passage of the Drug Quality and Security Act (DQSA), which was enacted in response to the deadly fungal meningitis outbreak and provides new laws for how compounding pharmacies should be regulated. In February, the FDA released new guidelines for regulatory oversight of compounding pharmacies based on DQSA.
A $100 million settlement was reached by the owners of the NECC, its insurers and some associated medical companies. The settlement will be offered to the victim compensation fund for those who developed meningitis after receiving tainted steroid injections.
In December 2014, the Justice Department arrested 14 individuals linked to the outbreak, filing charges and seeking jail time for the executives involved.