Bristol-Myers, FDA & A Lack Of Safety Warnings

Bristol-Myers, FDA & A Lack Of Safety Warnings

January 25th, 2012 // 2:04 pm @

Here is a twist on the old adage, ‘If a tree falls in a forest, does anyone hear it?’ Seven months ago, Bristol-Myers Squibb changed the label on its Kenalog steroid shot, which is frequently administered in epidural injections, to alert physicians that the medication should not be used near the spine after there were reports that some patients died or became paralyzed. Meanwhile, the FDA sent e-mails about the label change to about 200,000 people who signed up to receive agency safety alerts.

Nonetheless, doctors are apparently continuing to inject Kenalog near the spine either because they are have been ignoring the alerts or – still worse – they are unaware of the labeling change and FDA notices, Bloomberg News reports. “It is still being given in abundance,” Christopher Gharibo, head of pain medicine in the anesthesiology department at NYU-Hospital for Joint Diseases in New York, tells the news service.

The issue raises a troubling question about the extent to which drugmakers and regulators should go to ensure that the medical community is aware of important updates concerning new developments, particularly those concerning safety matters. In this case, for instance, both Bristol-Myers and the FDA maintain they took the necessary steps to fulfill their obligations, but the episode underscores that their moves were insufficient.

“I think they are irresponsible,” Curt Furbert, an epidemiologist at the Wake Forest School of Medicine in Winston-Salem, North Carolina, tells Bloomberg. In his view, the FDA should notify doctors about each new warning and require drugmakers to make labeling changes that are hard to miss. As Charles Bennett, a medication safety expert at the South Carolina College of Pharmacy in Charleston, points notes, most doctors “don’t even look at the label” on a drug they have used for years. “There has to be a better way of making sure doctors know about very serious side effects of drugs,” he says.

Even then, it is not clear whether FDA notices make a difference. A recent study concluded that FDA risk communications – such as Dear Doctor letters, public health advisories, safety alerts and Black Box warnigns – have had a varied and unpredictable overall effect. While some communiques have had immediate and strong impacts, many had either delayed or no impact on health care utilization or health behaviors, according to the study in Medical Care (back story).

In any event, neither the FDA nor Bristol-Myers gave much indication they were willing to do more, at least right now, to address the problem surrounding Kenalog. An FDA spokeswoman tells the news service that decisions about issuing press releases, for instance, are made on a “case by case basis,” but apparently did not define the threshold for doing so.

“The FDA acknowledges that communicating risk is challenging, and the agency remains committed to improving the capacity to provide the public with timely, accurate, evidenced- based safety information,” she tells Bloomberg. The FDA posted a notice on its website last year that a “potential safety issue” with the class of steroids that includes Kenalog was identified based on its analysis of reports about complications, the news service points out.

As for the drugmaker, a spokesman would only say that the warning was added after reviewing “post-marketing safety data.” There was no explanation offered to Bloomberg, however, as to why a communication was not sent directly to doctors, a step that drugmakers can, and sometimes, do take when safety issues arise.

Meanwhile, Bloomberg reports that, since 2004, epidural steroids were the prime suspect in serious complications suffered by 198 patients, according to an evaluation of FDA data performed for the news service by AdverseEvents, which analyzes safety reports. Kenalog and generic versions were named in 88 of reports. In all, 52 patients were hospitalized, 30 suffered disabilities from complications and 10 were listed as having “life-threatening events.”

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