Seven months ago Bristol-Myers Squibb issued a public safety alert and changed the label of the Kenalog injection to indicate that use of it in epidurals had been linked with “serious medical events, including death” and that use of it as an epidural injection was “not recommended.”
But according to reports Doctors are still injecting the steroid in a way the company warns they shouldn’t, following reports that patients have died or become paralyzed after receiving steroidal shots.
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.
Used for neck and back pain, Kenalog and the Pfizer Inc. (PFE) drug Depo-Medrol are the most frequently administered steroids in epidural injections. Over eight million such shots were given in the U.S. in 2010.
Bloomberg reports that experts believe this warning from the drug company has largely gone ignored or unnoticed.
Physicians are either ignoring the Bristol-Myers warning or aren’t aware of it, according to doctors who use Kenalog or who work with others who do. “It is still being given in abundance,” said Christopher Gharibo, head of pain medicine in the anesthesiology department at NYU-Hospital for Joint Diseases in New York.
Neither Bristol-Myers nor the U.S. Food and Drug Administration publicized the label revision, even though the FDA is reviewing the safety of epidural steroid shots. While not required to alert doctors or patients, the FDA has broadcast changes to other drugs’ prescribing information. In June, around the time the Kenalog label was rewritten, it issued a press release about a muscle injury risks warning that Merck & Co. applied to its Zocor cholesterol pill.
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.
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.
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.