FDA reviewing heart risks of Glaxo diabetes pill

April 12, 2013

(AP)—The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia.

Avandia was severely restricted in 2010 due to concerns about its impact on the heart.

Regulators announced the highly unusual move in a government notice Friday. The FDA will ask a panel of outside experts to review a new analysis of the key study about Avandia's heart risks.

A spokeswoman for Glaxo said the drug company commissioned researchers at Duke University to reanalyze the study, and submitted the results to the FDA last year.

The FDA first approved the drug in 1999 and it became the top-selling in the world by 2006. Sales began plummeting in 2007 after researchers began questioning the drug's safety.

Explore further: US panel backs novel diabetes pill from J&J (Update)

shares

Related Stories

US panel backs novel diabetes pill from J&J (Update)

January 10, 2013

A panel of U.S. health experts ruled Thursday that an experimental diabetes drug from Johnson & Johnson is safe and effective, though lingering safety questions must be tracked over the long term.

Recommended for you

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.