Image: Avandia
Paul Sakuma  /  AP
The ultimate decision of whether Avandia will be removed from the market is up to the FDA, which is expected to decide within the next few weeks.
updated 7/15/2010 9:43:10 AM ET 2010-07-15T13:43:10

An advisory panel to the Food and Drug Administration (FDA) came up with mixed reviews Wednesday for a drug that a number of studies have suggested puts patients at risk for heart disease and stroke. A panel of 33 physicians, patient advocates, and academics decided that Avandia, a drug commonly used in treating diabetes, should either be withdrawn from the market or sold under very strict controls.

Studies of Avandia have found that it can increase a person's risk of heart disease by as much as 43 percent, which is even more concerning considering that the disease it treats can double someone's risk for heart disease. And although much of that research has been disputed by the drug's manufacturer GlaxoSmithKline, the panel voted yesterday that the evidence was compelling enough to suggest that the risks are indeed real enough to pose a serious threat to people taking the drug.

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Still, physicians on the panel don't want to see the drug pulled entirely because, they argued, there aren't many good drugs available for treating diabetes as it is, and even a risky drug can be successful in treating some patients. "The decision speaks to the complexity of both this issue and of the information that's available," says David Kendall, MD, chief scientific and medical officer of the American Diabetes Association, who attended the hearings. "If this issue were a simple and clear-cut one, an advisory panel wouldn't be necessary."

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Of the 33 panel members who convened to decide the drug's fate, 12 voted to pull it off the market, 10 others felt that it should stay on the market but with stricter labeling and tighter controls, which, Dr. Kendall says, means that the warnings would be stronger and the language more understandable to the average adult. Seven panelists voted to add more warnings to the drug's label and leave controls as they are, and the final three said no changes should be made.

The ultimate decision of whether Avandia will be removed from the market is up to the FDA, and it's expected the agency will decide within the next few weeks. (Typically, the FDA follows the panel's recommendations.)

As Dr. Kendall notes, the panel's divided decision is another sign of a complex issue that began in 2007, when a study published in the New England Journal of Medicine found that the drug could increase a patient's risk of heart disease by 43 percent. While GlaxoSmithKline disputed those findings, the company later revealed revealed that it had known about the potential risks since 2005. The Senate Finance Committee published a report last February accusing the manufacturer of knowing about the increased risk of heart disease as far back as 2000 when it was conducting its initial trials of the drug.

Hoping to redeem the drug's reputation, a large study funded by Glaxo and the European Medicines Agency that was published in the June 2009 issue of Lancet found no difference in heart disease risk in patients taking Avandia versus those taking other diabetes medications. But this time, the FDA disputed that study. Thomas A. Marciniak, MD, with the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, reviewed the study and its findings, and found numerous flaws, foremost among them that dozens of cases of heart problems in patients taking Avandia had never been documented or included in the final results.

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At Wednesday's hearing, Dr. Marciniak accused Glaxo of intervening in the drug trial.
Also at issue at the hearing was Avandia's safety in comparison with another drug, Actos, which many doctors are already prescribing to patients in light of Avandia's bad press. The reason? Some studies suggest that Actos could increase the risk of bladder cancer, and it's known that the drug increases bone fractures, so physicians aren't sure if Actos will turn out to be another Avandia a few years down the road. The panel ultimately voted 20 to 10 to continue a trial comparing the safety of the two drugs.

Talk to your doctor
If you're taking Avandia, or were considering it, a conversation with your physician is in order. "Obviously, every medication has potential risks and benefits," says Dr. Kendall. One of the reasons Avandia is so popular (and the FDA is having such a hard time deciding whether to withdraw it) is that it's in a particularly effective class of medications that help the body respond better to insulin. "While there are other medications that make the body respond to insulin, Avandia and Actos are in a unique class of medications" that work really well, Dr. Kendall says.

How to live with type 2 diabetes

It's really up to you and your doctor to decide whether you should continue to take Avandia, says Dr. Kendall, but you should be aware of the side effects and your other treatment options:

  • Know the risks. "It's really up to people to be aware of these controversies and know that alternatives are available," he says. While Avandia's side effects are well publicized, there may be other risk factors, such as osteoporosis, that may make it a better alternative for you than Actos. "While it's important to pay attention to adverse affects, it's also important to manage diabetes," he adds. So discuss any fears you have with your doctor, and do some research on the other diabetes medications, such as sulfonylurea and metformin, that may work better. Whatever you do, don't stop taking Avandia without talking to your doctor first; doing so could raise your blood sugar levels.
  • Exercise—and eat right. "Heart problems are common in diabetes patients, independent of what medications they may be taking," Dr. Kendall says. There are other measures that are important to control or limit those problems, he adds, such as diet and exercise. Both help your heart, and a recent study found that resistance training could help control things like metabolic syndrome, which is common among diabetics and can also put you at risk for heart problems. For more tips, read the Guide to Managing Type 2 Diabetes.

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Video: FDA issues mixed verdict on Avandia

  1. Transcript of: FDA issues mixed verdict on Avandia

    WILLIAMS: And, Bob , I want to transition now into another major health story that actually has you in Washington tonight to cover it, the fate of this diabetes drug Avandia that affects millions of people who are on it.

    BAZELL: Yeah, Brian . Avandia is controversial because some say it increases heart attack risk. Today an FDA panel voted to leave it on the market, but with restrictions.

    Unidentified Man #1: There clearly are adverse signals of harm coming...

    BAZELL: Seventeen members of the expert panel wanted restrictions, 12 voted to ban the drug altogether, and only three opted to do nothing.

    Unidentified Man #1: It's very difficult for me to then justify that this is meeting the definition of shown to be safe.

    BAZELL: Dr. Steven Nissen of the Cleveland Clinic first raised the alarm about heart disease risk three years ago.

    Dr. STEVEN NISSEN: The committee clearly understands that there's a lot of risk here. There's very little evidence of any unique benefits.

    BAZELL: Before the first warnings, GlaxoSmithKline sold $1.8 billion worth of Avandia every year, in part because of a very heavy advertising campaign.

    BAZELL: But sales have gone way down, although doctors still wrote 2.6 million prescriptions for the drug last year, according to the research firm IMS Health . GlaxoSmithKline still maintained today that " Avandia does not increase the overall risk of heart attack , stroke or death."

    Mr. JEFF TENPENNY: What were you barking at, huh?

    BAZELL: Jeff Tenpenny took Avandia for his type 2 diabetes, and in 2005 he had a bad heart attack .

    Mr. TENPENNY: The pain was radiating out of my left shoulder, in particular, and down my arm, and in the jaw it was really excruciating.

    BAZELL: One case does not prove anything, but new studies that have come out in recent weeks made the case even stronger that there is a heart risk. Dr. Margaret Hamburg , the FDA commissioner , will make the final decision on what, if anything, to do next. Many people are waiting for the FDA 's final decision as an indication of how tough this agency's new leadership will be on pharmaceutical companies when danger signs appear about drugs that are already on the market. Brian :

    WILLIAMS: All right. Robert Bazell in our Washington bureau tonight with that. Bob , thanks.


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