A major drug trial of the diabetes drug, Avandia should be stopped because it puts patients at risk, says the consumer group, Public Citizen.
The U.S. Food and Drug Administration asked drug maker GlaxoSmithKline Plc (GSK) to test the long-term heart effects of Avandia when compared to rival, Actos (Takeda Pharmaceutical Co Ltd). Early indicators were that Avandia (rosiglitazone) increased the risk of heart attack.
With more evidence that Avandia poses a great heart attack risk than previously thought, Public Citizen says enrolling 16,000 patients in the TIDE trial puts patients at an unnecessary risk.
Dr. Sidney Wolfe of Public Citizen’s Health Research Group, along with Canadian researcher, David Juurlink wrote to FDA Commissioner Margaret Hamburg.
"A wealth of data now suggests" that Avandia carries greater risks than Actos, the researchers said. Patients are also not adequately informed about the safety differences between the two medicines when deciding whether to participate in the trial, they added reports Reuters.
The drug should be pulled from the market and the unethical international drug trial, ordered by the FDA should be halted said Wolfe testifying to Congress two weeks ago.
The TIDE drug trial (Thiazolidinedione Intervention With Vitamin D Evaluation), involves 14 countries and should finish enrolling patients by the year 2015.
The TIDE trial will be discussed by an FDA joint advisory committee in July and will be reassessed at that time.
Actos appears to be the safer of the two drugs, and the FDA put a black box warning on Avandia after an outside advisory panel noted in 2007 that it had a link to heart risks.
A Canadian study in 2009 found differences in the risk of congestive heart failure and death between groups of patients taking the two drugs.
The New England Journal of Medicine (NEJM) in May 2007 found Avandia raised the risk of heart attack by 43 percent.
Avandia sales plummeted after the report from the Cleveland Clinic. It was Glaxo’s second-biggest seller at $3.2 billion in 2006.
Meanwhile, GSK has had to settle about 700 lawsuits paying out claims to those who claim to have been injured by the drug. #