July 13, 2007Avandia side effects reports tripled after new study
A new study has found that reports of Avandia side effects to the Food and Drug Administration tripled in the month after the publication of an article detailing the heart risks of the drug. Experts say that the increase in reported cases of Avandia side effects is probably due to a greater awareness among doctors that the drug can lead to heart problems. The reports included cases of side effects among patients taking both Avandia and Avandamet, which contains the same active ingredient, rosiglitazone.
On May 21, the New England Journal of Medicine published a study which found that patients taking Avandia were 64% more likely to die from heart related problems and 43% more likely to suffer a heart attack than other patients.
According to a study by the Associated Press, reports of Avandia side effects tripled in the 35 days after the study was published compared to a similar period before its publication. The FDA received only five reports of heart attacks among Avandia patients in the month before the study was published, compared with 90 reports in the same period afterward. Reports of heart-related hospitalizations also increased, going from 11 to 126. A total of 38 deaths were reported among Avandia users in the month after the study, nearly four times the number of reports over the previous month.
Because reporting of a drug’s side effects is done on a voluntary basis, experts say that the increase is due to doctors’ greater awareness of Avandia’s potential for causing heart problems. This increased awareness should give experts a better understanding of the actual dangers of Avandia, several doctors have stated.
Dr. David Nathan, a diabetes specialist at Massachusetts General Hospital, says that it was “not conceivable” that only five patients of the one million who are taking Avandia suffered heart attacks in the one month before the NEJM study was published.
The FDA is planning to hold hearings to investigate the risk of Avandia side effects on July 30. The agency’s expert panel could recommend additional safety regulations for the drug, including issuing an Avandia recall.