TribLIVE

| USWorld


 
Larger text Larger text Smaller text Smaller text | Order Photo Reprints

FDA overturns safety limits on diabetes drug

Daily Photo Galleries

By The Associated Press
Monday, Nov. 25, 2013, 4:48 p.m.
 

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 no longer will 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 previously was limited to certain registered pharmacies. Those safety restrictions and others were put in place in 2010, severely curbing U.S. prescriptions for the GlaxoSmithKline drug.

The ruling on Monday 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 a more recent analysis of a key Avandia study shows that the drug's heart risks are no greater than other diabetes drugs.

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

The announcement represents a vindication of sorts for FDA leadership, including Woodcock, who only agreed to put restrictions on the pill after years of pressure from outside researchers, safety advocates and several members of Congress.

Dr. Steven Nissen of the Cleveland Clinic, whose research first raised concerns about Avandia, said the announcement “is about the FDA's effort to save face.”

“This is about appearances, not changing medical practice,” said Nissen, who chairs the Cleveland Clinic's department of cardiology. “A single re-analysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.” Nissen said he doesn't expect doctors to return to prescribing the drug, considering how many newer diabetes drugs are now available.

 

 
 


Show commenting policy

Most-Read Nation

  1. 121 tourists stranded on schooner near Statue of Liberty
  2. White House intrusions reveal problems with security, Secret Service
  3. Pentagon program seeks to retain U.S. technological edge against foreign rivals
  4. DHS headquarters’ planning goes awry
  5. Snowden: U.S. shared info about Americans
  6. Al-Qaida cell poses as great a danger as ISIS
  7. Ticks reduce moose population in northern states
  8. Egyptian Bary admits links to 1998 U.S. Embassy bombings in Africa
  9. Scope of Chrysler’s latest SUV recall questioned
  10. Threats from Mexican cartels lead protesters to scrap immigration rallies, organizer says
  11. Transgender girl crowned homecoming princess in Colorado
Subscribe today! Click here for our subscription offers.