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FDA Issues New Warnings on Testosterone Replacements

FDA Issues New Warnings on Testosterone Replacements

As of early March, the Food and Drug Administration (FDA) will require pharmaceutical companies that make testosterone replacements to warn patients about the potential risks of heart attack and stroke.

NPR reports that at first, testosterone replacements were only intended for men with testosterone deficiency due to medical conditions such as genetics, cancer and chemotherapy, and damaged genitals.

Yet the patient pool for testosterone replacements has grown significantly over recent years as doctors and clinics have prescribed them to men with lower-than-normal testosterone who are otherwise perfectly healthy. Low testosterone, otherwise known as “Low T,” is said to lowered libido and fatigue. Men naturally undergo a decrease in testosterone levels as they get older (levels peak at age 30 and tend to decrease at an annual rate of 1 – 2%) but some medical professionals have recommended testosterone therapy to ward off the effects of aging.

The FDA, however, never approved the treatment for that reason, and is now requiring the companies that make testosterone replacements to include a drug safety warning explaining its proper application and the associated risks for heart attack or stroke.

“The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging,” the FDA said in a statement. The regulatory agency is also mandating that the drug companies conduct a study to find out more about the potential negative side effects.

The changes were set in motion last September when a FDA panel ruled in a 20-1 decision to replace the drug warning labels and to require the drug companies to conduct a study on its side effects.

One of the leading manufacturers of testosterone replacements, AbbVie, said in a statement that it is more than willing to implement the changes and to cooperate with the FDA.

“TRT [Testosterone replacement therapy] is an important men’s health topic,” the company said in a statement. “AbbVie is committed to our patients and we continue to work with the FDA.”

However, Public Citizen’s Health Research Group, a consumer advocacy group, remains unconvinced. According to CBS News, it petitioned the FDA last year to issue a boxed warning, the strongest warning possible for a pharmaceutical drug. The FDA refused the request due to “insufficient evidence.” The organization found this reasoning to be suspect, considering, among other things, that the Canadian government had issued these warnings earlier.

“In the seven and a half months since the Canadian action, approximately 4 million prescriptions have been filled in the U.S.,” said Dr. Sidney Wolfe, the group’s founder. “Had the FDA made this announcement last summer when the Canadian government acted, it would have reduced the number of U.S. prescriptions for and damage from testosterone, a medication of questionable effectiveness for a large proportion of users and one that increases the risk of heart attacks and strokes.”

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