July 28--We've all been hearing about the potential side effects of the type-2 diabetes drug Avandia. But should people stop taking it completely? Do the benefits outweigh the risks? That's for each individual and their doctor to decide. But one thing you should not do is stop taking it without first talking to your doctor, the experts warn.
Diabetes experts inLa Cross, Wis., say patients should discuss their concerns about the drug Avandia and possible alternative drugs with their doctor. Avandia has come under harsh criticism in recent months by a number of experts, including FDA drug safety reviewers.
An FDA advisory panel recently agreed that the drug appears to increase heart risks, when compared with older drugs, but a majority ultimately voted to leave the drug on the market because the evidence was not definitive. The FDA is currently reviewing the panel's opinions and deciding what action to take.
Avandia's risks first drew attention in a 2007 study published in the New England Journal of Medicine that indicated the drug may increase the risk of heart problems by 43 percent.
According to an Associated Press story, the FDA first approved Avandia in 1999, and it quickly became the top-selling diabetes pill in the world. The FDA added a black box warning to the drug in 2007.
Critics have argued that Avandia should be withdrawn, as there is no reason to put patients at risk with the drug when there is an alternative in Takeda Pharmaceuticals' Actos, which does not appear to carry the same heart attack risk as Avandia.
Dr. Mary Frohnauer, a Gundersen Lutheran endocrinologist specializing in diabetes, said all patients taking Avandia should talk to their doctor about the risks and benefits of the drug.
"Patients shouldn't do anything rash and stop taking Avandia on their own," Frohnauer said. "They also need to remember there is a lot of benefit from taking this drug for many people.
"Avandia is not a bad drug, and it has very likely helped people in many ways control their blood sugars and reduce potential damage to eyes, kidneys and nerves," she said.
However, Frohnauer said, the controversy over the the drug's risks should cause doctors to carefully consider whether alternatives are more appropriate for some patients. "Doctors should consider medications like Actos, which works generally in the same way as Avandia, or other good replacements, depending upon the patient," Frohnauer said. Avandia and Actos work by increasing the body's sensitivity to insulin, a key protein needed for digestion that diabetics don't adequately produce. Local doctors say they have not received many calls from diabetic patients. "I have not received any calls in the last week," said Dr. Jane Korducki, a Franciscan Skemp endocrinologist who specializes in diabetes. "Nothing significantly has changed in the discussion with Avandia. "We've already had these discussions with our patients because we have known about the potential risks for some time, and we choose the medication that fits the patient's problem," she said. Korducki said patients with anxiety and concerns about the drug can consider alternative drugs. "But they should not stop suddenly taking Avandia because that could cause a whole set of consequences," she said. She said fewer new patients are taking Avandia due to concerns about the risks. "But Avandia works very well for decreasing insulin resistance and lowering blood sugars, so with the patient we come to a joint decision on whether to use that drug or even other classes of drugs," Korducki said. Frohnauer said other drugs are generally not as effective as Avandia in lowering blood sugars and directly reducing insulin resistance. "We're fairly conservative, and we don't race to put everyone on the drug," Frohnauer said. "It's not usually the first drug we try." Frohnauer said she has switched some patients from Avandia to Actos or other medications. But she warned that people should not make certain assumptions or jump to conclusions about Avandia. She said she has problems with the 2007 research, an analysis of several studies, because some studies did not have the best design or testing procedures. "That's why the FDA panel has struggled over this," Frohnauer said. "But the risk is still questionable, and it's better to err on the side of safety."
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