June 17, 2007Indian officials weigh Avandia ban
A leading Indian health official has announced that the country is considering a ban on the diabetes drug Avandia. Dr. M. Venkateswarulu, the Drug Controller General of India, says that if preliminary results from the agency’s monitoring of the side effects of Avandia shows a danger to Indian patients, doctors may be banned from prescribing it. In India, Avandia is sold under the name Windia.Concerns about the side effects of Avandia arose last month when a study published in the New England Journal of Medicine found that Avandia users face an increased risk of heart problems. According the study’s analysis of clinical trial data for Avandia, patients taking the drug were 64% more likely to die from heart problems and 43% more likely to suffer a heart attack than other patients.
Dr. Venkateswarulu says that as a result of the study, the Indian government will begin monitoring patients who use Avandia and another diabetes drug, Actos, for the next year to their health risks to diabetes patients. He says that if health officials observe an increased risk of side effects when preliminary results are available in six months, they will ban the drug.
Dr. Venkateswarulu also says that the Indian government will follow the lead of the Food and Drug Administration in issuing an Avandia recall or strengthening warning labels. “We are watching the situation in the US. If they come out with stricter warning, we will follow suit. We will not even hesitate to issue a ban,” Dr. Venkateswarulu says.
Dr. Anoop Misra, a diabetes specialist at Fortis Hospital, says that many doctors in India have already stopped prescribing Avandia to patients as a result of the potential health risks outlined in the NEJM study. “We have asked all our doctors to stop prescribing the drugs. Even those who were taking them have been prescribed different drugs,” he says.