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Testosterone treatment may not be safe


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Testosterone treatments are suspect. The U.S. Food and Drug Administration announced Jan. 31 that it has been investigating the risk of stroke, heart attack and death associated with taking FDA-approved testosterone products.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” the FDA wrote in its safety alert. “FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.”

The FDA made it clear that this was an investigation, not a rock-solid conclusion. The smoke is out there, and we shall see whether there is a fire burning under it.

The agency advised patients taking prescribed testosterone products to check with their health care professionals before discontinuing treatment. In the meantime, the FDA briefed providers on how to proceed.

“Health care professionals,” the FDA wrote, “should consider whether the benefit of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.”

One should only hope that this is not a situation in which patients used a drug with serious increased risks about which the manufacturer either knew or should have known and should have addressed. The FDA will look into it and, no doubt, will scrutinize the ominous medical science that stimulated the FDA’s probe.

When the worst case becomes the scenario, thank goodness for two things: There is modern medicine to help as many patients as possible to reach the road to recovery, and there is a first-rate justice system to protect injured patients’ rights.

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