Diabetes Self-Management Blog

It seems safe to say that it’s finally over: After over three years of clashes among scientists, pharmaceutical companies, and government regulators, the fate of Type 2 diabetes drug rosiglitazone (brand name Avandia) is sealed.

Two months after it ordered a halt to enrollment in a large-scale clinical trial of Avandia’s safety that it had requested three years earlier, the US Food and Drug Administration (FDA) issued a conclusive ruling on the heart risks associated with the drug. In a rare set of coordinated statements by the FDA and the European Medicines Agency (EMA), the FDA’s European Union counterpart, the two agencies announced that after reviewing all available data, they had come to the conclusion that the higher risk of heart attack associated with Avandia outweighed the drug’s benefits. But the two agencies set different policies in response to this conclusion. As described in a Reuters article, the EMA will simply remove Avandia from the market within the coming months. The FDA’s new policy, however, will require that doctors first exhaust all other options for new patients before they can prescribe Avandia. Current Avandia users can continue taking the drug only after reading a statement about its cardiovascular risks and acknowledging their understanding, and if their doctor certifies that Avandia is still the right choice for them. Given the wide variety of blood-glucose-lowering drugs available, this rule ensures that Avandia will all but disappear from the US market.

The new FDA policy underscores the reluctance of some doctors to switch patients from Avandia to other treatments in spite of the bad press and official safety warnings the drug has received in the last three years. Although Avandia sales revenue dropped from $3 billion in 2006 to $1.2 billion in 2009, according to the Reuters article, the later sales figure nevertheless represents a substantial sum for Avandia’s manufacturer, GlaxoSmithKline. FDA regulators may now simply be forcing the result they hoped their earlier warnings would achieve.

But why not simply ban sales of the drug, as the EMA will do? A possible explanation, of course, is that the FDA wants Avandia available when other available treatments fail to achieve their desired results. But given the expectation that Avandia will almost completely disappear — a prominent scientist quoted in the Reuters article estimates that sales will drop by 99% within six months — it appears that few, if any, patients will fall into such a situation. This raises the possibility of a more cynical motivation: Many experts believe that the drug’s removal from the market would embolden lawsuits on behalf of Avandia patients who suffered heart attacks. While such lawsuits can proceed without the drug’s removal, such an action by the FDA would undoubtedly be submitted as evidence that GlaxoSmithKline failed to adequately examine the drug’s risks in the first place. It is worth noting that the FDA has not always taken a more liberal approach to drug safety than European agencies. The drug metformin, now a mainstay of Type 2 diabetes treatment in the United States, was first approved by the agency in 1994 — 36 years after it was introduced in Europe.

What do you think — did the FDA and the EMA act appropriately in response to safety concerns, or should they have let the safety trial of Avandia reach its conclusion? Does the FDA’s policy of ending most use of Avandia without officially removing the drug make sense? If you currently take Avandia, how do you feel about the prospect of switching to a different treatment for your diabetes? Are you a former user who switched already? Leave a comment below!

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Comments
  1. I was an Avandia user until about three months ago. I requested the change to another TZD Actos. Ihad been redolute in not discotinuing the use of Avandia until recently because it is my belief that the retrospective meta analysis data was not conclusive. Apparently 21(I believe) members of the adviory committee also were not convinced. I asked to be switched, not because of concerns for safety, but I thought getting the drug would become difficult.The charge led by Dr. Nissin has been relentless toward this drug.

    Posted by Murray |
  2. Yes I was on Avandia for about 3 years. I think the only reason my doctor put me on it was because he had free samples to give me and a promise I suspect of freebies from the pharmacutical company. Of course that is just speculation on my part and may not be true. However I finally was taken off of it because my L1C levels for over two years were in the normal range of a non diabetic. I was so glad since I had being hearing bad things about if for a long timand I had to push my doctor to get me off of it. Actually another doctor was the one who took me off. My levels are goods so far!!

    Posted by Margaret Nipper |
  3. I was diagnosed as diabetic in 1974, suffered a heart attack in 1991 and a minor stroke in 1995. I took Actos for 3 months in 1999 and had numerous side effects and switched to Avandia in late 1999 and used it successfully until the recent brouhaha over its safety. During this 11 year period I had no heart problems of any kind and my glucose levels have stayed at non-diabetic levels. Nevertheless, due to the news about Avandia, I tapered off during the summer and stopped using it completely on July 15, 2010. So far, there has been no changes in glucose levels or any other negative effects from dropping Avandia. I know I will NOT take Actos under any condtions - I will walk on my treadmill 2 hours a day rather than suffer the side effets of that medicine. My conclusion is that Avandia has been a great drug for me and that Actos is terrible, but that stopping Avandia has not had any bad effects either. I hope this may be helpful to others in the same position. Ron Timmons, Indianapolis

    Posted by Ron Timmons |
  4. At the time I was on Avandia I had heart problems. Sress tests and echos were run a couple of times. Once I stopped it took awhile but I almost forgot I even had heart problems. Now, for some reason, I am again having problems. I am not on Avandia but another medication. Is it beause Avandia started all of this?

    Posted by Linda Comfort |
  5. I have taken Avandia for many, many years and I have had no heart problems. It has been a great drug for me too, I am currently still on it and will continue as long as I can. I also feel that people are individuals and nothing can be right for everyone, we react differently. I think the FDA and EMA have a responsiblity to look out for us and if there are more bad than good results happening maybe they should take Avandia off the market. I will miss it, and hope I don’t have problems and complications without it.

    Posted by Tara Meyer |
  6. The Indian Government has also banned the production and import of Avandia on the grounds that usage causes cardiac problems.

    Finally, the authorities have woken up to the menace of side-effects of these so-called miracle drugs and have taken some action. But this is based on the decisions by the FDA and European Agencies than by an investigation of its own.

    It has been observed that India has been a dumping ground for pharma companies with drugs that have been banned elsewhere given their toxic side effects and most of these drugs are still available freely, some even as OTC.

    Given that the governments are so slow in taking action, diabetics (and others who suffer from innumerable conditions) can only hope that God will take care of them.

    Posted by Badri |

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