Ahead of the Bell: FDA to begin review of Avandia
NEW YORK (AP) — The Food and Drug Administration plans to meet this week to reassess the safety of GlaxoSmithKline's former blockbuster drug Avandia, which was severely restricted in 2010 due to concerns about its impact on the heart.
An advisory panel of outside experts is scheduled to hear testimony Wednesday and Thursday on the drug, whose use was limited after the FDA determined that the potential risks of heart attack and stroke outweighed the drug's benefits.
Glaxo maintains that a key study showed Avandia was as safe as other diabetes drugs. The study followed patients for five years and tracked rates of heart attack, stroke and death did not show a statistically significant difference in heart safety between Avandia and older diabetes drugs, the drug company said.
The reliability of the study's results was a key topic of debate in the FDA's 2010 review of Avandia. Some FDA scientists said that the study was unreliable because it underreported heart attacks and other problems.
Currently U.S. patients can only receive Avandia after signing a waiver from their doctor indicating that they understand the risks and have tried other drugs to treat their disease.
It is possible the FDA could loosen restrictions on the drug if new evidence suggests it is not as dangerous as previously thought.
First approved in 1999, Avandia became the top-selling diabetes pill in the world by 2006, with sales of $3.4 billion. Sales began plummeting the following year after medical researchers began questioning the drug's safety. The drug was also banned in Europe.
Glaxo plead guilty last year to failing to report safety problems with Avandia to government officials over a seven-year period. The guilty plea was part of a larger $3 billion settlement with the Department of Justice — the largest health care fraud settlement in U.S. history — for various criminal and civil violations involving 10 of the company's drugs.