Avandia Side Effect Reports Are Skyrocketing
4 CommentsBy Ed Silverman // July 13th, 2007 // 12:10 am
But it’s not surprising, is it? Nonetheless, since the controversial analysis linking the diabetes med to cardiovascular risk was published May 21 in The New England Journal of Medicine, side effect reports to the FDA tripled. The sudden increase reflects the likelihood that many docs were unaware that Avandia may have caused heart problems that weren’t reported previously.
Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126, according to data obtained by The Associated Press through a Freedom of Information Act request to the FDA. The reports involve rosiglitazone, sold as Avandia and Avandamet.
The side effects reported range from as minor as a blister to as serious as sudden cardiac death. Most of the reports the AP reviewed seemed to involve serious side effects, and Avandia was listed by the FDA as the “primary suspect” rather than other medicines the patient may have been taking, the wire reports.
There were only 50 adverse event reports in January and 73 in February. From April 16 to May 21, when the study was published, 121 events were reported, including 11 deaths. In the 35 days after May 21, 357 events were reported, including 38 deaths.
“This is a very well-known phenomenon,” where news reports lead to increased reporting, Glaxo spokeswoman Mary Anne Rhyne tells the wire. “It’s good that there’s awareness of the reporting system, but drawing conclusions on such data is inappropriate.”
“You really can’t infer anything about incidence rates from that,” because the spike in reports is likely due to the “publicity effect” of the study, says David Graham, an FDA drug safety expert.
David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed, saying it was “not conceivable” that only five people among the 1 million Americans taking Avandia had heart attacks in the month preceding the May 21 study, as the FDA reports suggest. “It just heightens the concern about the poor reporting we have,” says Nathan, who has received speaker fees from Glaxo and other drugmakers.
Hank
Wow. It’s hard for me to disagree with David Graham, who knows a heck of a lot more about this than I do! But I guess I’d be more cautious. Of course, publicity-generated concern will raise the incidence of AERs. But it seems to me we don’t know whether that “means something or not.” Given how unreliable the Medwatch system is to begin with, we _may_ be getting precisely the kind of increased vigilance that a better system would induce. So it seems to me the significance depends on assessing the reports themselves.
Melody
“It just heightens the concern about the poor reporting we have,†says Nathan.
Dr. Nathan is right on target . . . we do see “poor reporting” and we also see a broken system. Until someone addresses the convoluted AER system, red flags don’t wave at the FDA until the pile of bodies–and strident media coverage–cannot be ignored.
Has anyone checked this system out? Besides being ‘voluntary’ in nature, and creating mountains of follow-up paperwork, the ‘categories’ are so numerous and far-flung that it difficult–until that body count soars–to recognize a problem. For example, if a drug was reported to cause ‘foot pain’, the AER system asks for specific details, e.g. big toe pain, little toe pain, rash on the instep, lesions on the arch, spasm, muscle twitch, ankle soreness, etc. etc. By the time someone recognizes that each sub-set is part of the much broader ‘foot pain’ category, significant time and harm has already accrued.
(This is only my interpretation after trying to digest a years’ worth of AE reports re: diabetes. Would be most appreciative of enlightenment from someone more knowledgeable about the system.)
Donald Cox
I think the evidence is still not there, Ed. I think we need a good and fair comparator study before we go off half-cocked about the safety of thiazolidinediones. This is getting to be a political nightmare.
jason
What is more dangerous to your health, glitazones or uncontrolled DM?
We need a better post marketing reporting system, who wants to pay for it?