Washington, DCThe annual observance of American Heart Month is a time for superlatives and overtures about heart health. Diet, exercise, excessive weight and smoking are the missives coming to the fore that can contribute to a healthy heart, or a heart attack.
The most recent drug to breed concern over the potential for cardiac side effects is Multaq, a drug designed to help regulate the heartbeat in patients suffering from atrial fibrillation. But there's a caveat: according to the latest warning by the US Food and Drug Administration (FDA), Multaq is only effective (and at its safest) when used to regulate temporary fibrillation and flutter.
If atrial fibrillation is permanent, then the FDA says it should not be used. There's a good reason for that. Sanofi, the French manufacturer of Multaq undertook a post-market study which found use of Multaq doubled the risk for heart attack in those patients. It's the second black-box warning for the drug since it was introduced in 2009.
During American Heart Month, you will likely not hear about lawsuits still on the books stemming from a drug known as Trasylol, a drug manufactured by Bayer to ward against excessive bleeding during surgery and in use since 1993.
But patients were dying from heart failure and stroke, and health advocates??"renowned researcher Dennis Mangano among them??"were left to crusade against a drug they felt was unsafe, not to mention the availability of cheaper, less-threatening alternatives.
When a Canadian-based Trasylol study was halted because too many study participants were dying, Trasylol manufacturer Bayer finally agreed to stop marketing the drug. Up to that point, warnings like those from Dr. Mangano, who opined on the CBS news program 60 Minutes that Trasylol was taking upwards of "a thousand lives a month," were falling on deaf??"if not dead ears.
Avandia and Actos are two drugs designed and prescribed to help manage Type II diabetes??"a condition impacting millions of Americans. According to the latest figures available from the National Institute of Diabetes, Digestive and Kidney Diseases, which falls under the umbrella of the National Institutes of Health, diabetes affected 8.3 percent of the US population in 2010. That figure seems small until you break out the numbers??"25.8 million people, the vast majority of whom have been duly diagnosed with diabetes, and of those??"a large majority are afflicted with Type 2 diabetes, the most common form.
Thus, millions of Americans are routinely taking medication to fight one disease, while risking their health in another area: in this case, their heart health.
The FDA operates on the premise that a drug is considered acceptable provided the benefits outweigh the risks. In this way, risks are a given. One wonders, then, why prescription drugs that can potentially cause heart side effects are rarely included in the dialogue during American Heart Month.
Perhaps they should. The impact of pharmaceuticals, and their association with potential cardiac side effects, would be a worthy addition to the existing focus on diet, weight, exercise and other factors during American Heart Month.
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