US authorities on Monday lifted restrictions on the prescription and use of the anti-diabetes drug Avandia after a new study indicated it did not carry an elevated risk of heart attacks.
The US Food and Drug Administration (FDA) announced the decision after considering the recommendations made by a 26-member panel of experts on June 6.
“Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research.
“Given these new results, our level of concern is considerably reduced; thus we are requiring the removal of certain prescribing restrictions,” she added.
The FDA move will include the removal of labeling which warns of a possible cardiovascular risk through taking the drug.
As soon as the changes are finalized the use of rosiglitazone (Avandia) will no longer be limited to use by certain patients, the FDA statement said.
The drug’s new indication will state that it may be used in conjunction with diet and exercise to improve control of blood sugar levels in patients with type 2 diabetes, similar to other diabetes drugs on the market.
The FDA slapped restrictions on Avandia in 2010, hitting sales of the drug manufactured by British firm GlaxoSmithKline.
Sales of Avandia started to slide in 2007 after researchers raised the possibility of a link between the drug and an increased cardiovascular risk based on clinical trial analyzes.
GlaxoSmithKline had insisted the drug — at one time the biggest-selling drug in the world with annual sales worth $3 billion — was completely safe.
[Image via Agence France-Presse]
SNL imagines Alan Dershowitz and Mitt Romney in hell during impeachment trial sketch
NBC's "Saturday Night Live"
The skit began with Sen. Susan Collins (R-ME) meeting with Sen. Mitch McConnell (R-KY) about impeachment.
They were then joined by Alan Dershowitz, who spoke of his previous clients, Jeff Epstein, O.J. Simpson and Claus von Bülow.
But Dershowitz suffered a heart attack and met the devil in hell, where he was reunited with Epstein.
McConnell then showed up and thanked the devil for teaching him "that thing with Merrick Garland."
CNN’s Don Lemon collapses on his desk in laugher as guests Rick Wilson and Wajahat Ali dunk on Trump
CNN anchor Don Lemon was infected with a case of the giggles Saturday night while discussing Secretary of State Mike Pompeo.
Lemon was joined by two hilarious guests, New York Times contributing op-ed writer Wajahat Ali and Rick Wilson, the author of the bestselling 2018 book Everything Trump Touches Dies: A Republican Strategist Gets Real About the Worst President Ever and the new book Running Against the Devil: A Plot to Save America from Trump -- and Democrats from Themselves.
The three were discussing Secretary of State Mike Pompeo’s interview with “All Things Considered” host Mary Louise Kelly, where he reportedly demanded she point to Ukraine on a blank map.
Amy Klobuchar wins endorsement in first in the nation primary from the New Hampshire Union Leader newspaper
Sen. Amy Klobuchar (D-MN) received a big endorsement on Saturday evening when her 2020 bid was endorsed by the New Hampshire Union Leader newspaper.
"If there is to be any realistic challenge to Trump in November, the Democratic nominee needs to have a proven and substantial record of accomplishment across party lines, an ability to unite rather than divide, and the strength and stamina to go toe-to-toe with the Tweeter-in-Chief," the newspaper wrote. "That would be U.S. Sen. Amy Klobuchar of Minnesota. She is sharp and witty, with a commanding understanding of both history and the inner workings of Capitol Hill."