Two Drugs for Diabetes Get Strict Warnings

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One year after its safety officers recommended the step, the Food and Drug Administration has finally slapped warnings on two major diabetes drugs. They are “rosiglitazone maleate” and “pioglitazone hydrochloride,” and they present health risks that have become well known in the past few months.

Essentially, these leading medications for type 2 diabetes have the potential to put one’s heart at risk. That risk heightens when the patient already has serious heart problems — which many diabetics do. In late May, the FDA wrote the makers of both drugs and asked them to put prominent warnings on the packages. But that didn’t stop the drugs from getting to patients with heart failure, putting them in harm’s way.

While rosiglitazone has received much of the attention lately for its potential in triggering a heart attack, pioglitazone is also being investigated. Evidence shows it, too, can raise one’s risk of cardiac problems, such as heart failure. Both are made by massive drug companies, “GlaxoSmithKline” and “Eli Lilly and Company” (respectively).

The FDA is now coming under fire in Congress. Officials are investigating why it took the FDA so long to put out these warnings on such mainstream drugs. Suggesting the agency “dropped the ball,” they say the FDA should have demanded that GlaxoSmithKline test its product to see if it raised heart attack risks years ago.

So somehow, the attention has flowed from the drugs to the drug agency. The FDA and drug laws in the U.S. have been criticized for quite a while as being too lax. Too many drugs are discovered, years later, to cause a certain side effect that forces them to put warnings or be yanked from the shelves. Still fresh in memory is the class of COX-2 inhibitors, strong painkillers used for arthritis. Many of these were found out — years later after millions had taken them — to cause unnecessary risk to the heart.

These diabetes drugs have triggered a political storm in Congress. Investigators are hearing from a lot of people: from patients who developed heart murmurs to doctors who were allegedly threatened by drug companies to keep quiet about the risks.

As consumers, it’s wise not to get caught up in the flurry of accusations against drugs heard on the evening news. Ask your doctor what the best move would be. Never stop taking a medication without asking a professional. And before you are written a prescription, inquire into the risks and side effects of a medication. Compare them to your individual situation. If heart attacks run in your family, then choosing a different diabetes drug is likely the better choice.

 

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