“Panel Rejects Sternest F.D.A. Warning for Steroid Shots” – NY Times

admin December 12, 2014 Comments

A panel of medical experts advising the Food and Drug Administration on Tuesday decided not to recommend slapping the sternest federal warning on steroid injections for neck and back pain, allowing their use to continue relatively unchanged. Millions of Americans get such treatments annually.

The F.D.A. had asked the panel to weigh in on whether the agency should require labels for the injections to carry the toughest federal warning, a so-called contraindication, that essentially would have signaled to doctors that the risks of use outweighed any possible therapeutic benefit. The agency often takes the advice of its expert panels, though it does not have to.

That wording was too broad, the panel decided, and it asked instead if there were any clinical situations in which the risks of steroid injections were greater than the benefits.

The majority of the panel voted yes — 15 to 7 — but nearly everyone who did so explained that the choice was made based on evidence showing the risks of a specific type of neck injection, a far narrower category of treatment that many doctors say is already being used less frequently.

“This is great news, it’s wonderful,” said Dr. Houman Danesh, director of integrative pain management at Mount Sinai Hospital. “We’ve been doing epidurals for six decades. This reassures us that they are a safe and effective treatment.”

He added that the vote “just reaffirms that there may be increased risk” with the procedure the experts singled out — injections of certain steroids in which the needle passes very close to a cluster of small important arteries in the neck.

Injecting steroids that have a granular texture can increase the risk that an artery will become blocked, causing a serious health problem. Dr. Danesh said that his practice had long stopped performing such injections because of concerns about just such risks.

The two-day meeting at the F.D.A.’s headquarters in Maryland was closely watched by pain specialists across the country. The administration’s original question was broad, and if the panel had opted for the sternest warning, that could have ushered in sweeping changes to the ways Americans are treated for back and neck pain.

The milder wording essentially maintained the status quo, though some doctors said it would be a useful signal to some practices that had continued to use the riskier neck procedure.

Administration officials estimated that one million Americans get epidural steroid injections each year, but many experts consider that an undercount. Dr. Laxmaiah Manchikanti, who runs a pain clinic in Paducah, Ky., and is chairman of the American Society of Interventional Pain Physicians, estimated that the number of injections administered was probably four million to six million a year. He said that the neck procedure that some on the panel had found questionable was known among clinicians to be risky, and that it accounted for only a small percentage of total injections.

“Actually they should just ban that procedure,” Dr. Manchikanti said. “It is very high risk, and so far there is no evidence that it works.”

Dr. William Landau, a professor of neurology at Washington University in St. Louis, said he believed that the broader category of epidural steroid injections should get the toughest labels. He contended there was little evidence that epidural steroid injections reduced pain.

“There’s no positive excuse for injecting this stuff except for the profits,” he said.

But many pain management specialists say that such epidural pain treatments work and are minimally invasive. They were seen unfavorably, the specialists say, only after a compounding pharmacy in Massachusetts distributed tainted steroid medication across the country in 2012, killing dozens and sickening hundreds.”