Make us your home page
Instagram

Today’s top headlines delivered to you daily.

(View our Privacy Policy)

FDA lifts restrictions on diabetes drug Avandia

WASHINGTON — The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.

The repeal means patients will no longer have to enroll in a special registry to be eligible to receive the drug. Additionally, the drug will be available at most pharmacies, whereas it was previously limited to certain registered pharmacies. Those safety restrictions and others were put into place in 2010, severely curbing U.S. prescriptions for the Glaxo­SmithKline drug.

Monday's ruling is a belated victory for the British drugmaker, which has spent more than a half-decade defending the safety of Avandia, once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks. After three years of debate, the FDA limited access to the drug in 2010.

But FDA regulators said Monday that a more recent analysis of a key Avandia study shows that the drug's heart risks are no greater than those of other diabetes drugs.

"Given these new results, our level of concern is considerably reduced," said FDA drug center director Dr. Janet Woodcock.

Dr. Steven Nissen of the Cleveland Clinic, whose research first raised concerns about Avandia, criticized the move. He said he doesn't expect doctors to return to prescribing it, since many newer diabetes drugs are now available.

Avandia was once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks.

Avandia was once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks.

FDA lifts restrictions on diabetes drug Avandia 11/25/13 [Last modified: Tuesday, November 26, 2013 12:13am]
Photo reprints | Article reprints

    

Join the discussion: Click to view comments, add yours

Loading...
  1. President Donald Trump during a rally in Huntsville, Ala., Sept. 22, 2017. Trump called for football fans to boycott NFL games unless the league fires or suspends players who refuse to stand for the national anthem.
  2. Rick and Tom podcast: Worst-Case (Keenum) scenario

    Bucs

    Rick Stroud and Tom Jones break down the Bucs' 34-17 loss to the Vikings on Sunday in Minneapolis in their latest podcast.

    Minnesota Vikings quarterback Case Keenum (7) scrambles away from Bucs defensive end William Gholston (92) during the first half. [LOREN ELLIOTT   |   Times]
  3. Tonight: Hear ideas for remaking downtown Tampa interchange

    Transportation

    TAMPA — New concepts for rebuilding the downtown interchange will be discussed at a Florida Department of Transportation community meeting Monday night.

    The Florida Department of Transportation renamed its controversial Tampa Bay Express plan, also known as TBX. The plan is now known as Tampa Bay Next, or TBN. [Florida Department of Transportation]
  4. Did you watch the second episode of 'Star Trek: Discovery'? Or just the first?

    Blogs

    CBS finally, finally, finally premiered its long-awaited new Star Trek series Discovery on Sunday night, albeit a bit delayed after 60 Minutes.

    Michelle Yeoh and Sonequa Martin-Green play the captain and first officer of the Shenzhou.
  5. Rick Scott's office deleted critical messages related to post-hurricane nursing home deaths

    As Florida continues to pick up the pieces in the aftermath of Hurricane Irma, more confusion builds around the 11 heat-related deaths at a South Florida nursing home following the storm earlier this month.

    Police surround the Rehabilitation Center in Hollywood Hills, Fla., which had no air conditioning after Hurricane Irma knocked out power. Several patients at the sweltering nursing home died in the storm's aftermath. [John McCall | South Florida Sun-Sentinel via AP]