Quantcast
Channel: Fighting Diabetes, Proactively!
Viewing all articles
Browse latest Browse all 5

Avandia May Pose Heart Risk

0
0

To Ban or Not to Ban  — FDA All Set to Debate Avandia Safety Concerns

When Avandia was first marketed in the late 1990s, doctors considered it a miracle drug for diabetics. Sales per annum reached the billion-dollar target and peaked at $2.3 billion in 2006. Then, in 2007, came the crash — the FDA restricted its use citing a study that claimed that Avandia increased the possibility of cardiac arrest and fatality.

Sales plummeted by almost half in the next two years. The 2007 study was the first of the many blows Avandia has received lately, others being a report prepared by the Senate Finance Committee criticizing the role of the FDA and more recent research that reinforces the findings of the original 2007 study. The latter, published on 28 June, indicates that Avandia (generic name rosiglitazone) can increase the possibility of heart attack by a massive 39%.

Another study, also published 28 June, promises more gloom for GlaxoSmithKline, the manufacturers of Avandia. David Graham of FDA and his team went through the insurance history of more than 220,000 patients to reach their conclusion: Avandia and another drug, Actos, could lead to not just heart attacks, but also increase the chances of stroke by 18%. What makes this study more authentic is the number of patients studied. Earlier studies could be faulted on lines of bad sample sizes that did not cover the entire population. Both the studies could have a significant impact on FDA’s decision when it deliberates on whether to pull Avandia from the market.

GlazoSmithKline has been quick to refute the latest claims. A company spokesperson said that there were six other studies to establish the effectiveness and safety of Avandia. A statementissued by the company said that there were studies to show that Avandia does not increase the risk of heart attack, stroke, or death.

The new studies doubting the safety of Avandia have also increased the pressure on FDA to ban the diabetes drug completely. Dr. David Juurlink from the University of Toronto has questioned the prescriptive use of this drug, arguing that safer alternatives were available.

All is not lost for Avandia, however. A team from the Washington School of Medicine studied an earlier research (not aimed at analyzing the link between Avandia and heart attack) to find out the risk of heart attack in patients who were prescribed Avandia. Dr. Richard Bach, who led the team, said that their analysis did not show any link between Avandia and heart attack.

Critics of Dr. Bach’s analysis claim that the sampling of patients for the study is flawed and therefore the conclusions are not credible. The FDA, however, has promised to take this study, besides other data, into consideration before they pass a verdict on whether or not to ban Avandia. The FDA debate is set for July 13 and 14.


Viewing all articles
Browse latest Browse all 5

Latest Images

Trending Articles





Latest Images