Doctors have largely ignored a warning issued by the makers of the Kenalog steroid injection, commonly used in an epidural injection during labor, despite that warning indicating use of it in certain indications could cause serious injury, permanent disability or death.
It was seven months ago when Bristol-Myers Squibb issued a public safety alert and changed the label of the Kenalog injection to indicate that use of it in epidurals has been linked with “serious medical events, including death” and that use of it as an epidural injection was “not recommended.” The company will not go so far as to say Kenalog was responsible for those deaths or injuries and the Food and Drug Administration failed to issue its own alert, as it usually does, when Bristol-Myers Squibb changed the labels on Kenalog.
Bloomberg reports that experts believe this warning from the drug company has largely gone ignored or unnoticed. Use of Kenalog is on the rise and as many as 8 million injections of the steroid were administered in 2010, presumably many of them as epidural treatments. There is also increasing questions as to why the U.S. Food & Drug Administration (FDA) has not publicized the perceived dangers of Kenalog, even after the makers of the steroid had publicized them. The same report indicates the FDA is currently conducting a review on the safety of Kenalog.
An interview with an epidemiologist at Wake Forest School of Medicine told Bloomberg he believed the FDA was “irresponsible” in not issuing some sort of public alert on the potential dangers of Kenalog as an epidural injection, especially being fully aware that it continues to be used in that indication.
Physicians are likely ignoring safety labels on the drugs they’ve been using for years and it is the FDA’s responsibility to recognize this and issue stronger warnings, especially since the agency is looking to gain more power in the regulatory landscape and complains that it lacks the authorities to protect public safety from potentially dangerous drugs.
The FDA defended its actions on Kenalog to Bloomberg, saying that a press release on the potential dangers of the injection was emailed to about 200,000 who receive regular updates from the agency. Whether there are actual prescribing physicians receiving those updates is unknown and based on the increased use of Kenalog, especially use that seems to ignore warning about its specific use in epidural injections.
Bloomberg presumes use of Kenalog as an epidural steroid injection continues to rise because it is covered by most major insurers, so doctors who use it are guaranteed to be reimbursed for its use.
Kenalog has been implicated in at least 88 adverse reaction reports of serious injuries after its use as an epidural injection to the back or neck. At least 13 deaths have been reported among people who received any epidural steroid injection to the back or neck since 2008 when that injection, and some of those include the use of Kenalog.