Avandia linked to cardiovascular risk again

The FDA panelists on Wednesday voted to recommend keeping a diabetes drug Avandia on the market even though the majority admitted that evidence is sufficient that this drug increased risk of heart risk among others.

Among 33 members of the FDA advisory panel, 12 voted to withdraw the diabetes drug, 10 voted to keep it on the market, seven voted to add further warnings, three voted that the drug should be allowed to be sold without any change in its status and one abstained.

Dr. David Graham, a veteran epidemiologist of the FDA, presented his findings against Avandia at the hearing held on July 13 and 14.

In a study also released two weeks before the meeting in Journal of American Medical Association, Dr. Graham and colleagues found that compared to its competitor, rosiglitazone or Avandia increased risk of acute myocardial infarction, stroke, heart failure, and death by 9, 27, 25, and 14 percent respectively.

The study involved 227,571 Medicare beneficiaries aged 65 years or older who started treatment with Avandia or its competitor through a Medicare Part D prescription drug program from July 2006 through June 209 and who were followed for up to 3 years.

In a study released in 2007, Dr. Steven Nissen, a world-famous cardiologist at Cleveland Clinic, meta-analyzed data from 42 randomized controlled trials involving Avandia and found diabetes patients on the drug were at 40 percent higher risk of acute myocardial infarction compared to non-thiazolidinedione therapies.

Many diabetes patients may be consfused by the FDA panelists' votes. What do the votes mean in terms of the safety of Avandia?  Why should a drug that has been found to carry a high cardiovascular risk be allowed to stay on the market while its competitor offers similar therapeutic effect, but much less risk is available?

Dr. Grahamd told Medpage Today he believed that the selection of the FDA advisory panelists, meaning whatever resulting from the votes is probably influenced by the composition of the advisory members.