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FDA Advisory Panel: No Label Needed for Steroids used to Treat Back Pain

Update Date: Nov 26, 2014 11:04 AM EST

The advisory panel for the U.S. Food and Drug Administration (FDA) did not recommend adding the agency's toughest warning labels onto controversial steroid injections for back pain. Even though steroids have been used to treat back pain, the FDA has not approved them for this type of treatment specifically.

After reviewing data, the Anesthetic and Analgesic Drug Products Advisory Committee concluded that using steroid injections in the neck could yield more cons than pros. During this neck injection procedure, the needle gets inserted near a small group of arteries. Due to the proximity, the panel expressed concern that this type of procedure can increase people's risk of a blocked artery.

Steroid injections, in general, can lead to rare but serious side effects, such as death, paralysis, spinal cord blockage, blindness, stroke, seizures, brain swelling and nerve injury. However, the panel concluded that the benefits outweigh the risks for steroid injections used to treat back pain.

Steroid use has been debated endlessly. In a recent study published in the New England Journal of Medicine, researchers headed by Dr. Janna Friedly, an assistant professor of rehabilitation medicine at the University of Washington in Seattle, concluded that steroid injections are not helpful. Dr. Friedly added that people should consider alternatives. On the other hand, some experts, such as Dr. Houman Danesh, a specialist in pain management and rehabilitation and physical medicine at Mount Sinai Hospital in New York City, believe that steroid injections can be safe and effective.

"Steroid injections have been practiced longer than we have had a vaccine for polio, and after six decades the FDA has decided to review the safety and efficacy of these injections," Dr. Danesh noted, according to Philly.

Even though the FDA does not always listen to the advisory panel, the agency still takes the recommendation into account.

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