Calm Urged for Avandia Patients
No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed
WebMD News Archive
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
"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
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
"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
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."