A federal scientist?s warning Monday that the diabetes drug Avandia could increase blood pressure and cause heart attacks has some doctors putting the pills on hold.
“I don?t want to put new people on it until I know where things stand,” said Dr. Philip A. Levin, endocrinologist with Mercy Medical Center in Baltimore. “The drug has been effective at lowering blood sugars, and it has caused fluid retention that made us caution about using it in any patient with a heart condition, because we don?t want to tip anyone over the edge.”
Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, justify taking Avandia off the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.
About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body?s sensitivity to insulin, resulting in more than $2 billion in sales each year.
The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.
Glaxo officials, meanwhile, disputed that claim, citingtheir own analyses of studies of Avandia, also called rosiglitazone.
“The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents,” said Dr. Ronald Krall, the company?s senior vice president and chief medical officer.
A review of the drug was moved up following a May New England Journal of Medicine analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.
The slideshow, from the FDA doctor known for raising the alarm about Vioxx, has increased uncertainty in the field, Levin said.
“The data is too fragmented, and it?s coming from too many sources rather than having everybody sitting together around the same table,” Levin said. “The FDA?s got to show some direction one way or the other.”
The Associated Press contributed to this report.
