home
RSS
September 23rd, 2010
11:34 AM ET

Diabetes drug Avandia restricted by FDA

The controversial diabetes drug Avandia will stay on the market, but the U.S. Food and Drug Administration restricted its use to patients with type 2 diabetes who cannot control their illness with other medications.

The restrictions are based on studies showing an increased risk of serious heart problems, including heart attacks and strokes, in patients taking Avandia, the FDA said Thursday.

Just minutes after the FDA posted its decision on its website, its European counterpart, the European Medicines Agency, announced that it’s going further and suspending approval for the marketing of Avandia in Europe. If the decision is finalized by the European Commission, the drug will be removed from the European market, along with two medications Avandamet and Avandaryl that combine Avandia’s active ingredient with other drugs. Dr. Hans-Georg Eichler, the agency’s senior medical officer, said he expects a final decision within “a few weeks.”

The FDA’s move runs counter to the recommendation of a senior scientist, Dr. Gerald Dal Pan, who advised the agency to pull Avandia from the market altogether. Dal Pan heads the FDA’s Office of Surveillance and Epidemiology, which oversees the safety of drugs that have previously been approved.

In explaining her decision, FDA Commissioner Margaret Hamburg said the agency “is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.” Approximately 600,000 Americans take Avandia, and those patients may continue taking the drug, Hamburg said, “if they are benefitting and they acknowledge that they understand the risks. Doctors will have to attest to patients’ eligibility.”

Avandia is used to control blood sugar in type 2 diabetics. It was approved by the FDA in 1999 and by 2006 was widely prescribed, with sales of more than $3 billion in 2006. But the drug came under close scrutiny in 2007, when Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, published an analysis which showed a 43 percent increase in heart attacks for patients on Avandia. The finding led the FDA to order GlaxoSmithKline (GSK), the drug’s maker, to conduct a thorough study of its safety. The full results of that study – known as RECORD – were made public last year. While GSK said the safety data was reassuring, the study came in for blistering criticism at a July meeting of an FDA advisory committee, where Dr. Thomas Marciniak, an FDA scientist who reviewed the data, said GSK ignored several cases of patients who suffered severe adverse effects.

In June, another FDA scientist, Dr. David Graham, published an analysis which came to similar conclusions as Nissen had. The accumulation of negative findings led the advisory panel to recommend a clampdown on use of Avandia, although the panel’s vote was split, with 17 in favor of restrictions, while 12 members voted to pull it from the market entirely and three said no action was needed.

On Thursday, the FDA ordered GSK to develop a program to ensure that access to Avandia is tightly controlled. It also ordered the company to pay for an independent review of the RECORD study, and ordered a stop to another study comparing Avandia with Actos, a competitor’s drug.

Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, sounded a mixed note after hearing of the decisions. “It’s taken too long to stop the use of a drug that clearly was harming people. We’ve got to fix this system.” At the same time, he said he’s satisfied with the FDA and European moves. “The use of Avandia and related products will essentially cease in the U.S. and Europe. I will anticipate that 99 percent of the use of this drug will cease worldwide.”

Others who have studied Avandia were more critical. Dr. John Santa of Consumer Reports Health called the FDA’s failure to withdraw the drug, disappointing. “It’s frustrating for us to see there are still several hundred thousand patients on this,” Santa said. “We have concerns that many of those people don’t realize there are other alternatives that are more effective and less risky.”

Paul Thacker, who as an investigator for Senator Charles Grassley (R-Iowa) and the Senate Finance Committee accused GSK of burying negative information about Avandia, said the FDA is being too timid. “When you look at all the evidence provided by Congress to the FDA about misconduct by GSK, and when you look at the numerous independent studies saying that the drug is harming patients, what evidence does the FDA want to have to make a decision that a drug needs to be yanked? What evidence do you need?” Thacker left Grassley’s staff this month for a position with the Project on Government Oversight.

FDA Commissioner Hamburg and Dr. Eichler of the European Medicines Agency each downplayed their split, saying the two agencies agreed on Avandia’s risks but chose different strategies to manage it. “We discussed the decisions with each other. These decisions were not made in isolation,” Hamburg said.

A slight note of discord came from Dr. Janet Woodcock, who heads the FDA division that evaluates medicines, who said “There is still considerable uncertainty of the magnitude and existence of this cardiovascular risk.” In a memo, Woodcock said that patients might still benefit from Avandia if they did not respond to other medications.

Medical groups warned that patients should not stop taking Avandia without first talking to their doctors. A joint statement from the Diabetes Society, the American Association of Clinical Endocrinologists and the Endocrine Society said stopping medication “can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.”

In a statement, GSK said it still has faith in its product. Wrote Chief Medical Officer Dr. Ellen Strahlman, “The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.

Type 2 diabetes is a condition that affects the way the human body metabolizes sugar. Symptoms include weight loss, fatigue, blurred vision, frequent urination, and increased hunger and thirst. There is no cure, but patients can manage their conditions with proper diet and exercise; medications or insulin therapy may also be needed, says the Mayo Clinic.

About 8 percent of the U.S. population - or nearly 24 million people - is living with diabetes, and 90 percent of those cases are type 2, according to the National Diabetes Information Clearinghouse.

Here are alternatives for people with diabetes if you are concerned about Avandia.


soundoff (272 Responses)
  1. GvdbCrulk

    cialis tadalafil vs viagra https://boxtadafil.com/ – how long does tadalafil take to work tadalafil walmart

    May 3, 2021 at 00:20 | Report abuse | Reply
  2. LbsoZisse

    us cialis purchase https://ucialisdas.com/ – 36 hour cialis 30 day free cialis

    May 3, 2021 at 10:31 | Report abuse | Reply
  3. GtnbCrulk

    better than viagra http://jokviagra.com/ – women and viagra performance anxiety viagra

    May 3, 2021 at 22:00 | Report abuse | Reply
  4. RebfZisse

    cialis tadalafil. au https://rcialisgl.com/ generic cialis forums

    May 4, 2021 at 02:14 | Report abuse | Reply
  5. FmrfEncox

    tadalafil ( cialis ) https://cialisee.com/ brand cialis trial pack

    May 5, 2021 at 04:10 | Report abuse | Reply
  6. JebgEncox

    Valtrex https://pharmacylo.com/ canadian pharmacy cialis

    May 5, 2021 at 05:12 | Report abuse | Reply
  7. BbshMile

    viagra foods http://loxviagra.com/ – where can i buy viagra online viagra usage

    May 5, 2021 at 15:30 | Report abuse | Reply
  8. LbsoZisse

    cialis price south africa https://ucialisdas.com/ buy 20mg cialis

    May 5, 2021 at 17:49 | Report abuse | Reply
  9. RebfZisse

    is cialis over the counter in canada http://rcialisgl.com/ no prescription female cialis

    May 6, 2021 at 12:39 | Report abuse | Reply
  10. GtnbCrulk

    how long does viagra stay in your system https://jokviagra.com/ can i take 200mg of viagra

    May 7, 2021 at 01:28 | Report abuse | Reply
  11. FmrfEncox

    cialis 20 mg https://cialisee.com/ – cialis without a prescription paypal cialis viagra sales

    May 7, 2021 at 07:06 | Report abuse | Reply
  12. AnooEncox

    is there a womens version of viagra http://llviagra.com/ how good does viagra work

    May 7, 2021 at 14:06 | Report abuse | Reply
  13. AnooEncox

    viagra kobieca http://llviagra.com/ what to do if a child swallows viagra

    May 7, 2021 at 22:15 | Report abuse | Reply
  14. LebnEncox

    Altace https://xlnpharmacy.com/ men's health

    May 8, 2021 at 12:03 | Report abuse | Reply
  15. LebnEncox

    Asacol https://xlnpharmacy.com/ Baycip

    May 9, 2021 at 13:06 | Report abuse | Reply
  16. BbshMile

    can a woman take viagra http://loxviagra.com/ how much does generic viagra cost

    May 9, 2021 at 18:30 | Report abuse | Reply
  17. JebgEncox

    pharmacy http://pharmacylo.com/ dysfunction

    May 9, 2021 at 19:31 | Report abuse | Reply
  18. LbsoZisse

    cialis 20 mg usa http://ucialisdas.com/ viagra cialis canada

    May 10, 2021 at 09:20 | Report abuse | Reply
  19. GtnbCrulk

    natural viagra recipe http://jokviagra.com/ viagra and blood pressure

    May 10, 2021 at 22:49 | Report abuse | Reply
  20. RebfZisse

    mexico cialis http://rcialisgl.com/ – cialis without a prescription cialis in melbourne

    May 10, 2021 at 23:26 | Report abuse | Reply
  21. FmrfEncox

    cialis cheap https://cialisee.com/ – cheap online cialis buy cialis uk

    May 12, 2021 at 07:01 | Report abuse | Reply
  22. LbsoZisse

    order cialis no prescription http://ucialisdas.com/ best prices for cialis

    May 12, 2021 at 23:25 | Report abuse | Reply
  23. BbshMile

    natural alternative to viagra https://loxviagra.com/ – viagra samples walgreens what does viagra do for women

    May 13, 2021 at 03:42 | Report abuse | Reply
  24. JebgEncox

    Reglan canadapharmacy24h Viagra Plus

    May 13, 2021 at 13:53 | Report abuse | Reply
  25. RebfZisse

    cialis soft http://rcialisgl.com/ – black cialis overnight buy cialis online paypal

    May 13, 2021 at 17:46 | Report abuse | Reply
1 2 3 4 5

Leave a Reply to Jackson Cheater


 

CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.