Epidural corticosteroid injections linked to severe adverse events in new FDA warning

by John Chapman

The Food and Drug Administration has issued a new warning about the risk of severe complications for patients who are treated with epidural steroid injections. Corticosteroids are sometimes used by doctors to treat symptoms of back pain, although they have not been approved by the FDA for this use.

According to the FDA warning, injection of corticosteroids into the epidural space of the spine has been linked to a number of severe adverse effects, including loss of vision, stroke, paralysis, and death. A 2007 study published in the medical journal Spine uncovered 78 cases of severe complications linked to the epidural injection of corticosteroids, including at least 13 deaths.

Based on these findings, the FDA will require the manufacturers of corticosteroids to add a new warning about the dangers of using these drugs to treat back pain via local injection. Health officials in New Zealand and other countries have already required that corticosteroid medications carry warnings about the dangers associated with the epidural injection of these drugs.

Despite the FDA warnings, safety advocates say that because the practice of administering corticosteroids through epidural injections is so widespread, additional steps need to be taken to protect patients with back pain from the severe complications associated with these drugs. Doctors in the U.S. administer more than 9 million epidural injections each year.

According to its own admission, the FDA has known for years about the potential link between the epidural injection of corticosteroids and a risk of severe adverse effects. The agency first announced concerns about the dangers of corticosteroids in 2011, and said that it had been concerned about the safety of these drugs as early as 2009.

The FDA has said that it will convene an advisory panel to review the health risks associated with epidural steroid injections and determine whether additional safety measures need to be taken. The committee of experts is scheduled to meet later this year to determine the agency’s next step regarding corticosteroids.

Victims of Complications from Corticosteroid Injections May Be Entitled to Compensation

Despite the recent FDA warning, concerns about the safety of corticosteroid injections are nothing new. In April 2014, we reported on a $2.88 million verdict that was awarded to the parents of a Missouri man who was diagnosed with meningitis caused by antibiotic-resistant MRSA bacteria following a steroid injection to relieve back pain.

If you or a loved one have suffered complications from the epidural administration of corticosteroids for back pain, or if you have been injured by other medications prescribed by your doctor, you may be entitled to file a lawsuit and receive compensation. To learn more about your legal rights and receive a free legal consultation regarding your case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001, or by following the link to our free case evaluation form on this website.