Why Avandia and Actos Carry New Safety Warnings

Be on the lookout for symptoms
The dust eventually settled around the Avandia controversy after weeks of aftershocks. In addition to the first study, Avandia was also linked to a greater risk of osteoporosis in women. And another study showed that Actos did not increase the risk of heart attack, but did boost the risk of heart failure, a condition in which the heart pumps inefficiently and causes swelling of the feet and shortness of breath.

However, the benefits of Actos may outweigh the risk because patients who took it had a lower risk of heart attack, stroke, and death than those who did not.

The U.S. Food and Drug Administration updated the labeling for both diabetes drugs in late 2007, made them both off-limits for patients with existing heart failure, and warned doctors and patients to keep an eye out for heart failure symptoms such as:
• Excessive, rapid weight gain
• Difficulty breathing or shortness of breath
• Swelling due to a buildup of excess fluid

And in 2008, the federal agency and GlaxoSmithKline notified doctors and pharmacists that patients must now receive a medication guide in each Avandia prescription (a step reserved for drugs that "pose a serious and significant public health concern").

If you experience any of these health problems, you should tell your doctor immediately because they can signal heart failure, according to the U.S. Food and Drug Administration. Your doctor may decide to reduce your dosage or discontinue the medication altogether.

"The drugs have had a lot of attention and people have started to look at them more critically," said Dace Trence, MD, an endocrinologist and director of the Diabetes Care Center at the University of Washington Medical Center in Seattle. "Endocrinologists are more careful in making a decision and they may well be prescribing thiazolidinediones with more caution and they will follow the person more carefully and closely."

Read more about the side effects of Avandia, Actos, and similar drugs here.