Kenalog, made by Bristol-Myers Squibb Co. and Phizer’s Depo-Medrol are steroid injections intended for use in neck and back pain patients. According to Bloomberg, both steroids are the most commonly used in an off-label manner for epidural procedures. The same Bloomberg report states that over 8 million injections of these products were given in 2010 alone.
Seven months ago, Bristol-Myers changed the labeling on their Kenalog steroid product, stating that is is “not recommended” for injections as an epidural. The change was due to “reports of serious medical events, including death” that have been associated with the use of steroids as an epidural. Despite the warning, physicians are still using Kenalog and Depo-Mendrol injections for epidural purposes. Pfizer has not released a warning, similar in nature, for their Depo-Mendrol product.
The concern for many is that neither Bristol-Myers or the U.S. Food and Drug Administration (FDA) publicly announced the label revision. While the FDA is not required to alert doctors or patients of changes, they have chosen to broadcast prescribing changes for other drugs. This has led many to speculate that the physicians aren’t aware of the label change or are ignoring it. The FDA stated that the label change was communicated to 200,000 patients and physicians who have signed up for such alerts.
According to the Bloomberg report, FDA data indicates that epidural steroids have accounted for 198 adverse reactions in patients since 2004. Depo-Mendrol and generic versions were cited in 90 cases, including three related deaths. Kenalog and generic versions were named as the prime suspect in 88 cases. These adverse reaction reports account for 52 patients that were hospitalized, with 30 suffering disabilities from the complications and 10 listed as having “life-threatening events”.
Further research into the steroid injections showed incidents of serious complications or death following pain shots. A 2007 survey of physicians from the medical journal Spine found 78 cases of patients who received epidural steroid shots in the neck, who suffered serious injuries, including 13 deaths. All of the injuries and deaths followed injections of methylprednisolone, a steroid that includes Depo-Mendrol and the generic versions of the steroid.
Mark Wallace, chairman of the pain medicine division for the University of California at San Diego’s health system, found two death cases after epidural were given with the steroid triamcinolone, which is found in Kenalog.
Under FDA rules, manufacturers are supposed to notify the FDA regarding any adverse reaction reports they receive, physicians and other health professionals are not bound by the same rules. According to government estimates, only 1% to 10% of adverse drug reactions are reported to the FDA.
If you or a loved one have been injured by a defective drug or an off-label drug prescription, call a Sarasota product liability attorney today from the personal injury law firm of Lutz, Bobo & Telfair, P.A. Our lawyers may be able to help. Our law firm offers no cost consultations for personal injury cases. Our fees are also handled on a contingency basis. This means that we only charge attorney’s fees if we win the case.