Pharma

Epidural injections of steroids for back pain under review by FDA

The U.S. Food and Drug Administration is reviewing epidural injections of steroids to treat neck and back pain following a warning by Bristol-Myers Squibb (NYSE:BMY) seven months ago that administering its Kenalog steroid around the spine could cause serious complications, according to a report by Bloomberg. Bristol-Myers in New York revised its label for Kenalog […]

The U.S. Food and Drug Administration is reviewing epidural injections of steroids to treat neck and back pain following a warning by Bristol-Myers Squibb (NYSE:BMY) seven months ago that administering its Kenalog steroid around the spine could cause serious complications, according to a report by Bloomberg.

Bristol-Myers in New York revised its label for Kenalog to say it is not recommended for injection into the epidural space near the spine because of “reports of serious medical events, including death,” associated with administering steroids that way, the article said. But the drugmaker and the FDA have not yet publicized the label change, Bloomberg said.

The article cited physicians who said the steroid is still widely used in epidural injections to treat neck and back pain.

Bristol-Myers’ steroid Kenalog and the Pfizer (NYSE:PFE) drug Depo-Medrol are the most commonly used steroids for epidural injections, Bloomberg said. More than 8 million such shots were administered in the U.S. in 2010.

FDA spokesman Morgan Liscinsky told Bloomberg the regulator is in the midst of reviews for epidural injections of steroids — one focusing on injections in which the needle is used very close to critical arteries. In another, the FDA is working with outside experts looking at particulate steroids that could create blockages that could set off a stroke if injected into arteries, the article said.