New warnings issued by federal drug regulators suggest that side effects of epidural corticosteroid injections may cause severe injury or even death.
On April 23, the FDA issued a drug safety communication, alerting the medical community and patients about the risk of rare, but serious, neurological problems that can occur after receiving injections of corticosteroids into the epidural space of the spine. The agency says it will require new label warnings for all such injections.
The FDA began reviewing the safety of the injections after medical professionals raised concerns, reporting serious events that have included death, spinal cord infarction, full and partial paralysis, blindness, strokes, seizures, nerve injuries and brain edema.
The agency says that while many patients recovered within minutes to 48 hours after the injections, many patients have never recovered from the epidural steroid injection problems.
Epidural corticosteroid injections are used in the pain management industry to treat neck and back pain, but the FDA has never approved them for that purpose. The agency also warns that they are not proven safe or effective in treating pain.
In a study published in the medical journal Spine in March 2013, researchers found that patients given epidural steroid injections received little if any benefit and in many cases fared worse than those not given the injections.
In their conclusion, the researchers theorize that the additional volume added to the body by the fluid in the injection may actually exacerbate the pinched nerve and cause more pain after the short-term pain relieve is gone. The shots may also cause long-term damage to the nerve roots, which the FDA appears to confirm with its latest warning.
The FDA warned doctors that the neurological damage from epidural injections have been reported with and without the use of fluoroscopy, urging doctors to discuss the risks with patients before prescribing the injections. The agency also urged doctors to tell patients to seek immediate emergency treatment if they experience symptoms of epidural steroid injection complications, including vision loss, tingling in limbs, sudden weakness or numbness, dizziness, severe headache, or seizures.
While it is illegal for drug manufacturers to promote corticosteroids, or any drug, for uses not approved by the FDA, doctors are allowed to prescribe drugs for any purpose they see fit. The agency says it will seek to raise awareness of the risks of the injections through its Safe Use Initiative.
A panel of experts was convened on the issue to look at techniques for using the injections more safely. The FDA says it will release the recommendations once they have been finalized.
Warning Follows Deadly Meningitis Outbreak
Corticosteroids used off-label for pain injections include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. They are generally used to reduce inflammation and swelling.
Methylprednisolone was the steroid used in thousands of recalled epidural steroid injections that led to a nationwide fungal meningitis outbreak in 2012 and 2013.
The outbreak sickened more than 700 patients and killed more than 60. It was traced back to back pain injections distributed by the New England Compounding Center (NECC) to hospitals and pain management centers nationwide.
The U.S. Centers for Disease Control and Prevention estimates about 14,000 patients in the U.S. were exposed to the tainted shots, which in some case had visible particles of fungus in them.
After an epidural steroid injection recall in October 2012, which later expanded to all of drugs compounded by NECC, the pharmacy was forced to cease operations and its compounding license was revoked.
NECC was eventually driven into bankruptcy under the weight of litigation and fines faced, and the incident resulted in new regulations for compounding pharmacies nationwide.