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Avandia and Cardiovascular Concerns

Gretchen Becker Health Guide May 23, 2007
  • The Internet is all abuzz with the recent news that people taking the drug Avandia (rosiglitazone) have significantly higher rates of cardiovascular events (heart attacks and fatal heart attacks) than people who don't take the drug.

     

    Physicians' offices are being bombarded with calls from patients taking the drug, asking if they should stop. This is not surprising, as all the articles tell patients to "talk to your health care provider" to see if they should stop taking the drug.

     

    It is important for anyone taking, or thinking about taking, Avandia to know about the increased risks from taking this drug. Side effects are one of many factors you should consider when deciding whether or not to take any drug, including aspirin. The other factors include the effectiveness of the drug compared with other diabetes drugs; the other side effects of the drug, both short-term and long-term, mild or more serious; possible interactions with other drugs or over-the-counter supplements you may be taking; the cost of the drug and whether or not your insurance plan will help to pay for it; and whether any risks of taking the drug are greater than the risks of having higher blood glucose levels.

     

    All drugs have side effects. What you need to do before you take a new drug is to try to determine, with the help of your doctor, whether it's worth risking the side effects of a new drug in an attempt to reduce the risks of the disease itself. Sometimes the only way to decide is to take the drug for a while and see how effective it is for you, and whether you get any short-term side effects.

     

    The scary part for anyone with a chronic disease are the long-term side effects, which sometimes don't show up until years after people start taking a drug. It was only recently that they found that long-term use of the glitazone drugs, of whichAvandia is one, increases the rate of bone fractures in elderly women. Cancer drugs often cause hair loss in the short term. It was only after decades that they discovered that cancer drugs used to cure Hodgkins disease in teenagers caused heart disease in middle age. Not good. But being alive with heart disease is probably preferable to being dead without it.

     

    What we need to remember is that many life choices also have side effects, both short and long term. Examples are dietary choices, exercise or lack thereof, emotional stress, drinking alcohol, driving cars, riding snowmobiles, driving tractors, and crossing the street.

     

    An analysis like the Avandia analysis would undoubtedly show that people who drive automobiles have greater accident rates than people who stay off the roads. But does everyone give up driving? Nope.

     

    A similar analysis would undoubtedly show that people who drink and drive have greater accident rates than people who don't drink and drive. But do people stop drinking and driving? Nope.

     

    In fact, just drinking to excess and staying home is dangerous. So is living off fast food and eating a vegetable only once a year. People know this. But do they change their eating habits? For the most part, nope.

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    Many "benign" over-the-counter medications such as Tylenol (acetaminophen) can be fatal; there is special danger with acetaminophen in heavy drinkers or aspirin in children with chickenpox (Reye's syndrome). Do people stop taking acetaminophen and aspirin? For the most part, nope.

     

    Anyone who is panicked about the recent Avandia study should keep these things in mind. Yes, the study showed a significant increase in cardiovascular events. However, the absolute number of cardiovascular events was small (86 heart attacks in 14,371 patients taking Avandia (0.473%) vs 72 in the 11,634 patients not taking the drug (0.619%). And the mean baseline A1c was 8.2%, meaning that on average, these patients were at increased risk of heart attacks to begin with. Of course, if you or someone you loved had been among the 12 extra heart attacks in the Avandia group, you wouldn't care that the risk had been low. And if you multiply the increased risk by the total number of people taking the drug, the increased number of cardiovascular events would be much larger.

     

    But it's not as if you're apt to keel over tomorrow because you've been taking Avandia. (I, myself, took it for 3 months in a clinicalresearch study and then decided to go back to metformin because it had a longer track record. The endo in charge, a wise woman, said to me, "Avandia may turn out to be the best thing since sliced bread, but it's still new, and we really don't know yet.")

     

    So take a deep breath. Put this news into your cranial computer, and take it into account when you're seeing your doctor and reviewing your drug regimen. Remember, we know that high blood glucose levels cause complications. So we're always weighing one risk against another. Improved diet and increased exercise are the most benign treatments. But if you can't get those to work for you, you may need drugs, either oral or injected. In general, insulin has the longest track record, but for many years only animal insulins were available. We still don't know the long-term effects of some of the new "designer insulins."

     

    The scary thing about the Avandia news is the suggestion that GlaxoSmithKline's own analysis suggested increased cardiovascular events with the drug. They claim that longer-term analysis countered that finding. But who among us can trust what pharmaceutical company flaks tell us? Not me.

     

    The other scary thing is the suggestion that the FDA isn't really doing its job. We can't trust the drug companies in a world driven by the bottom line. The FDA should represent the public, but any governmental organization is also driven by ambition and politics.

     

    Today in Asia, unscruplous people are selling fake antimalarial and other drugs, killing children as well as adults in the process. Adulturated supplements and fake drugs sometimes reach the American market and sometimes result in deaths. We would like to believe that the FDA is protecting us against these scams, but we can't always be sure.

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    We need to be vigilant. But we should not panic. Stay informed. Don't buy medications or supplements from obscure Internet sources. And pay attention to any side effects you get from any drug. Then make an informed choice about whether the risks outweigh the benefits in your own individual case.