Avandia Is the New Vioxx

And the latest blockbuster drug to be associated in hindsight with serious health risks is ... drum roll ... Avandia!

A diabetes drug manufactured by GlaxoSmithKline, Avandia has been prescribed to more than 6 million people since its licensing eight years ago. But in a review of 42 studies involving 28,000 people, researchers found that people taking Avandia had a 43% higher risk of heart attack -- and a 64% higher chance of dying from heart disease -- than those taking other drugs or placebos.

The original trials, which led to the drug being approved, did not look at its effect on the heart, say the study's authors, Steven Nissen and
Kathy Wolski from the Cleveland clinic in Ohio. Dr Nissen told the
Guardian: "I would have preferred it if, right after the drug was launched they'd done a large-scale cardiovascular outcome study. Eight years on, unfortunately we still haven't had a complete one." [...]

GSK said it "strongly disagrees" with the findings. The review was not the best way to establish whether a drug has side-effects, it said, because it pulled together information from many trials designed in different ways. The best way to be certain is to run a large, long-term clinical trial looking at risks and benefits in patients. Several of these are in progress and some have been published. One found a small increased heart risk; others found none.

A lot of digital ink will soon be spilled on Avandia, what the FDA and
Glaxo should have known and should do now, and the methodology of
Nissen's study, so I'm going to hold off on commenting until more information is available. But one lesson can already be drawn:

"I'm not convinced to stop using them," said Dr. Christopher D. Saudek, director of the Johns Hopkins Diabetes Center. "But the clinical lesson is not jumping in with the newest drug - use more established drugs more, and brand-new drugs less."

Health alert over diabetes drug linked to heart risks [Guardian]

Drug for diabetes is linked to heart risks [Baltimore Sun]