But it's not surprising, is it? Nonetheless, since the controversial analysis linking the diabetes med to cardiovascular risk was publishedMay 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.