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 (339 Responses)
  1. Zisseloh

    where to get the best price on cialis https://rcialisgl.com/ – cost of cialis at costco cialis with effexor

    May 26, 2021 at 00:45 | Report abuse | Reply
  2. EncoxHtf

    cialis mit paypal bezahlen https://cialishav.com/ – cialis bph canadian pharmacy cialis 40 mg

    May 26, 2021 at 22:10 | Report abuse | Reply
  3. EncoxGtv

    canada drugs scam Plavix consumer reports canadian pharmacies

    May 27, 2021 at 10:05 | Report abuse | Reply
  4. ZisseVed

    buy tadalafil online https://krocialis.com/ – cvs cialis price how to buy cialis online?

    May 27, 2021 at 20:52 | Report abuse | Reply
  5. MileSwa

    discount generic cialis https://ckacialis.com/ – cialis 80 mg canada toronto cheap fase cialis

    May 28, 2021 at 00:00 | Report abuse | Reply
  6. EncoxHtf

    cialis and food https://cialishav.com/ – cheap cialis 10mg cialis mastercard

    May 28, 2021 at 09:07 | Report abuse | Reply
  7. EncoxAni

    cvs pharmacy store hours sunday https://pharmacyken.com/ – prescription drugs discount canada drugs no prescription

    May 28, 2021 at 14:43 | Report abuse | Reply
  8. EncoxAni

    chinese online pharmacy https://pharmacyken.com/ – Mestinon desoxyn online pharmacy

    May 28, 2021 at 21:46 | Report abuse | Reply
  9. CrulkAsd

    where to buy cialis in australia https://cialisjla.com/ – i need cialis overnight generic cialis overnight delivery

    May 29, 2021 at 07:18 | Report abuse | Reply
  10. Zisseloh

    does cigna cover cialis https://rcialisgl.com/ – discounts on cialis cialis softtabs online

    May 29, 2021 at 12:23 | Report abuse | Reply
  11. EncoxDev

    canadian online pharmacies methadone canadian pharmacy symbicort canadian pet pharmacy

    May 30, 2021 at 02:58 | Report abuse | Reply
  12. EncoxDev

    online colleges for pharmacy tech best online canadian pharmacy review mexican pharmacy what to buy

    May 31, 2021 at 02:24 | Report abuse | Reply
  13. ZisseVed

    side effects of cialis daily once daily cialis get online cialis without prescription overnight

    May 31, 2021 at 07:44 | Report abuse | Reply
  14. Zisseloh

    generic cialis release date viagra vs cialis mastercard cialis

    May 31, 2021 at 17:41 | Report abuse | Reply
  15. CrulkAsd

    cialis vs viagra canadian pharmacy best way to take cialis generic cialis in canada

    May 31, 2021 at 20:19 | Report abuse | Reply
  16. EncoxGtv

    planet pharmacy canada canadian pharmacies shipping to usa express scripts com pharmacies

    June 1, 2021 at 17:43 | Report abuse | Reply
  17. EncoxHtf

    cialis how long cialis cost per pill cialis didnt work

    June 1, 2021 at 20:15 | Report abuse | Reply
  18. ZisseVed

    cialis online uk viagra cialis on line parmacy generic cialis 10 mg price cheap

    June 2, 2021 at 00:51 | Report abuse | Reply
  19. MileSwa

    buy cialis with paypal buy cialis from canadian pharmacy cialis,com

    June 2, 2021 at 23:54 | Report abuse | Reply
  20. EncoxHtf

    cialis 10mg online brand cialis usa cialis one a day

    June 3, 2021 at 08:36 | Report abuse | Reply
  21. EncoxAni

    pharmacy school canada mail pharmacy Diltiazem

    June 3, 2021 at 12:05 | Report abuse | Reply
  22. Zisseloh

    cialis prescription online cost of cialis with insurance pt 141 and cialis

    June 3, 2021 at 14:49 | Report abuse | Reply
  23. EncoxAni

    cheap prescription drugs canada are canadian online pharmacies legit methylcobalamin injections canadian pharmacy

    June 3, 2021 at 19:04 | Report abuse | Reply
  24. CrulkAsd

    cialis is for daily use cialis paypal brand cialis no prescription

    June 4, 2021 at 01:01 | Report abuse | Reply
  25. EncoxDev

    pharmacy school canada canada pharmacy, 800-15355 24 ave, surrey, bc v4a 2h9, canada cheap prescription drugs in canada

    June 4, 2021 at 10:39 | Report abuse | Reply
  26. EncoxDev

    Bupron SR are drugs from canada safe Tetracycline

    June 5, 2021 at 02:44 | Report abuse | Reply
  27. ZisseVed

    cialis risks cialis puerto rico price of cialis in pakistan

    June 7, 2021 at 07:57 | Report abuse | Reply
  28. Zisseloh

    to buy cialis generic cialis online shopping cialis professional 20 lowest price

    June 7, 2021 at 18:12 | Report abuse | Reply
  29. MileSwa

    cialis at ?2 per tablet cialis without prescriptions uk generic cialis online australia

    June 7, 2021 at 18:48 | Report abuse | Reply
  30. EncoxHtf

    buy generic cialis atralia buy cialis no prescription cialis once a day

    June 8, 2021 at 17:51 | Report abuse | Reply
  31. EncoxGtv

    Lotrisone gastro health canadian pharmacy equivalency exam

    June 8, 2021 at 19:34 | Report abuse | Reply
  32. CrulkAsd

    buy cialis cheap generic vs brand name cialis cialis 10 mg where to buy

    June 8, 2021 at 19:43 | Report abuse | Reply
  33. ZisseVed

    prices cialis cialis southafrica does cialis lower your blood pressure

    June 9, 2021 at 07:03 | Report abuse | Reply
  34. Zisseloh

    how does cialis help bph how to buy cialis from us stores cialis tolerance

    June 9, 2021 at 14:46 | Report abuse | Reply
  35. EncoxHtf

    cialis cheaper cialis black 800mg cialis 5mg daily cost

    June 9, 2021 at 22:55 | Report abuse | Reply
  36. EncoxAni

    safe online pharmacies the drug store pharmacy columbus ohio pharmacy store in india

    June 10, 2021 at 02:26 | Report abuse | Reply
  37. MileSwa

    the cialis promise program buy cialis with american express cheap generic cialis canada

    June 10, 2021 at 05:57 | Report abuse | Reply
  38. EncoxAni

    pharmacy checker canada best online mexican pharmacy friendly rx pharmacy

    June 10, 2021 at 07:22 | Report abuse | Reply
  39. EncoxDev

    online pharmacy without prescription canadian pharmacy eliquis mexican prescription drugs

    June 12, 2021 at 23:58 | Report abuse | Reply
  40. CrulkAsd

    cialis low dose cialis online europe why buy cialis. com

    June 13, 2021 at 10:42 | Report abuse | Reply
  41. buy chloroquine phosphate uk

    hydroxychloroquine 200 mg tab chloroquine new zealand difference between chloroquine phosphate and hydroxychloroquine

    June 13, 2021 at 11:31 | Report abuse | Reply
  42. EncoxDev

    in store pharmacy Ceftin amazon prescription drugs

    June 13, 2021 at 17:34 | Report abuse | Reply
1 2 3 4 5 6

Leave a Reply to EncoxGtv


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.

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.