FDA Advisory Panel Says Steroid Shots for Back Pain Can Continue

FDA Advisory Panel Says Steroid Shots for Back Pain Can Continue

FDA Advisory Panel Says Steroid Shots for Back Pain Can Continue

Experts decided against backing any new warning label for controversial injections

SOURCES: Houman Danesh, M.D., specialist, pain management and rehabilitation and physical medicine, Mount Sinai Hospital, New York City; U.S. Food and Drug Administration

TUESDAY, Nov. 25, 2014 (HealthDay News) -- An expert advisory panel to the U.S. Food and Drug Administration decided on Tuesday not to recommend the agency issue a strong warning against the general use of steroid injections for back pain.

The shots are commonly used to treat back pain, but they have never been approved for this use by the FDA, and whether their risks outweigh their benefits has long been a matter of debate.

Tuesday's vote, from the FDA's Anesthetic and Analgesic Drug Products Advisory Committee, essentially leaves the continued use of steroid shots for back pain largely unchanged.

As reported by The New York Times, the panel of experts said that only in one type of procedure -- a specific type of neck injection -- could the risks of the shots possibly outweigh a possible benefit.

That procedure is one where the needle comes very close to a grouping of small, important arteries in the neck. Those types of injections could raise the odds of a blocked artery, and have already been abandoned by most doctors, the Times reported.

However, experts have been divided for years on whether steroid shots actually ease back pain.

One study published earlier this year in the New England Journal of Medicine found that people who have lower back pain caused by spinal stenosis -- a common condition among those over the age of 60 in which the open space in the spinal canal narrows from inflammation -- are unlikely to get relief from steroid shots.

Study author Dr. Janna Friedly, an assistant professor of rehabilitation medicine at the University of Washington in Seattle, said at the time that, "These steroid injections aren't helpful. There is no added benefit to the steroid itself, so if people are considering these injections, I would recommend that they consider an alternative."

However, Dr. Houman Danesh, a specialist in pain management and rehabilitation and physical medicine at Mount Sinai Hospital in New York City, said he believes these injections are both 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," he noted.

Danesh believes the FDA's current interest is based on an incident in 2012, when more than 700 people contracted fungal meningitis and other infections that resulted in more than 60 deaths, all the result of a single compounding pharmacy distributing steroids contaminated with a fungus that caused these complications.

He added that effectiveness of steroid injections has been studied in multiple clinical trials in the past. "One of the first studies, in 1977, was a placebo-controlled, randomized study. This study showed up to 70 percent improvement in pain with steroid injections, compared with 43 percent with placebo," he said.

In 2008, studies showed as many as 91 percent of people getting these injections reported significant pain relief, Danesh said.

"Steroid injections are a safe and effective means of treating nerve irritation in the spine," he added.

More information

Visit the U.S. National Library of Medicine for more on steroid shots.

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