Why Avandia and Actos Carry New Safety Warnings

holding-avandia-package
It is still beneficial for many, but not for heart-failure patients.
(DIABETESMINE.COM)
If you have type 2 diabetes, it was hard to miss the avalanche of negative news about the drug Avandia (rosiglitazone) in 2007. A study linked Avandia to an increased risk of heart attack, which prompted a closer look at Actos (pioglitazone), a second drug in the same class (both are thiazolidinediones).

The ensuing back and forth debate on the drugs—which lasted for weeks and was widely reported in the news—left people confused and concerned.

Never halt medication without consulting your doctor
Sheri Gibson, a 49-year-old Avandia user, was so disturbed by the health scare that she stopped taking the drug. Gibson, a regular on the dLife message boards, said her chat room compadres were evenly split on the drug's safety. Gibson eventually decided to finish her supply of Avandia.

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It was a good decision. One thing all experts agree on: You should never halt the drugs abruptly in response to news stories.

"One of the most important things is people should not stop taking their medications without talking to their health-care provider," cautions Jane Seley, a certified diabetes educator and diabetes nurse practitioner at NewYork-Presbyterian/Weill Cornell Medical Center. "That's very scary to me because the potential harm of suddenly stopping taking your Avandia—not treating your high blood sugar—because of what you heard on the news is probably far worse than the potential risk (of taking it)."

However, you should be aware of the risks and side effects of any drug that you are taking and act promptly if you have problems.

Dick Robbins, age 72, of Hot Springs Village, Ark., was taking Actos and scheduled a doctor's appointment to discuss his problem with foot swelling (a potential side effect). "When I got there I told him that I was concerned about the Actos; I'd been reading about it online," he says. His physician suggested a switch to Novolog insulin, which he did.

"I went off of it and went on Novolog; within five or six days, the swelling was gone," he says.
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."
Reported side effects of thiazolidinediones include:

• Upper respiratory infections and sinusitis
• Headaches
• Mild anemia
• Fluid retention, which could lead to heart failure
• Weight gain
• Muscle pain

According to the U.S. Food and Drug Administration, women who take rosiglitazone (Avandia) or pioglitazone (Actos) could increase their risk for upper arm or foot fractures.

One thiazolidinedione, called Troglitazone (Rezulin) has been taken off the market in the United States and some European countries because it has been shown to cause severe liver problems in a small number of patients.

Newer thiazolidinediones (rosiglitazone and pioglitazone) have not been shown to cause liver damage; however, they may still pose a risk. Symptoms include:
• Nausea, vomiting, and abdominal pain
• Fatigue
• Loss of appetite
• Yellowing of the skin or the whites of the eyes (jaundice)
• Dark urine

If you are taking one of these medications and have these symptoms, report them immediately to your doctor.
Last Updated: May 16, 2008
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