WASHINGTON (AP) — The Food and Drug Administration will hold a meeting in June 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.
Regulators announced the highly unusual move in a government notice published on Friday. The FDA said it will ask a panel of outside experts to review a new analysis of the key study examining Avandia’s heart risks.
A spokeswoman for Glaxo said the drug company commissioned researchers at Duke University to reanalyze the study, called RECORD, which followed patients for five years and tracked rates of heart attack, stroke and death. The new analysis “did not show a statistically significant difference,” in heart safety between Avandia and older diabetes drugs, according to company spokeswoman Mary Anne Rhyne.
The reliability of the study’s results was a key topic of debate in the FDA’s previous review of Avandia.
Glaxo argued that the study showed Avandia was as safe as other diabetes drugs. But some FDA scientists said that the study was unreliable because it underreported heart attacks and other problems.
Ultimately, the agency decided to severely limit which patients could take the drug, concluding that the potential risks of heart attack and stroke outweighed the drug’s benefits.
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. London-based Glaxo voluntarily stopped marketing the drug in 2010.
Presumably, 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.
Last year Glaxo plead guilty 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.
Shares of GlaxoSmithKline PLC fell 5 cents to close at $48.47 in trading Friday.