Calm Urged for Avandia Patients
No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed
Calls for Calm in Wake of Avandia Alarm
At least since 2005, the FDA has been aware of the possible heart attack risk of Avandia. But there's conflicting evidence, including a study of more than 30,000 diabetes patients in a large health maintenance organization (HMO) that found no extra heart attacks among Avandia patients.
For this reason, the FDA has decided not to pull Avandia from the market. Instead, the FDA is working as fast as it can to pull together an expert advisory panel to weigh all the available data.
The FDA warns patients not to stop taking Avandia on their own. Drexler agrees.
"When people read these stories about heart attack risk, they often stop taking their diabetes drugs," he says. "The resulting deterioration of their care can be very detrimental. Everyone says, 'Consult your doctor before stopping any prescribed medication,' but we really must stress this point more strongly."
An editorial released on Wednesday by the editors of the British medical journal The Lancet takes the unusual step of criticizing the NEJM for the "urgency" in the tone of the Nissen paper and an accompanying editorial.
"To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of [Avandia] is needed," the Lancet editors write. "Alarmist headlines and confident declarations help nobody."
Drexler notes that an ongoing study, the RECORD clinical trial, is studying whether Avandia truly causes heart problems. But the study will not be finished until the end of 2008 or 2009, depending on how many patients develop heart disease.
Another study, the ACCORD trial, which is studying outcomes in 10,000 patients with type 2 diabetes, should also reveal the true risks and benefits of Avandia. That trial, too, is years from completion.
GlaxoSmithKline, the company that makes Avandia, says these trials are being monitored by independent safety boards. Patients should be reassured by the fact that these safety boards have seen no reason to stop the studies, says GSK Chief Medical Officer Ronald Krall, MD.
"The data safety monitoring boards have done an interim analysis very recently and have reassured us there is nothing in that analysis that should affect the conduct of the study or be of concern," Krall tells WebMD. "They have looked at the specific issues raised by Dr. Nissen. Because cardiovascular events are the RECORD study endpoints, they have looked at them in great detail."