Public Citizen Requests FDA Require A Black Box Warning on Prescription Testosterone Supplements

For men who are experiencing low testosterone levels, a condition coined by big pharma as Low T, there are different kinds of testosterone products available to raise the level of the hormone in their body. Unfortunately, these products pose a serious health risk.

Recent research has shown that testosterone supplements can significantly increase the risk of heart attacks, strokes, and death. For instance, in a study conducted at UCLA, there was a twofold increase in the risk of a heart attack among men under 65 who had a history of heart disease; there was also a twofold increase in risk among men over 65, regardless of whether or not they had a history of heart disease.

Why isn’t this risk better known?

One of the complaints against the companies who manufacture and sell testosterone supplements is that they’ve tried to downplay or cover up the cardiovascular risks, along with failing to disclose the risks in the package inserts.

Public Citizen, a public advocacy group, recently petitioned the FDA to require a black box warning on testosterone products. Black box warnings are the strongest kind of warning the FDA can require companies to put on a product. The black box warning for testosterone supplements would highlight the cardiovascular risks, particularly the significantly elevated risk of heart attacks.

The advocacy group also reviewed research studies testing the cardiovascular risk of testosterone supplements. Unsurprisingly, they found that the studies funded by the drug manufacturers didn’t show an elevated risk. However, the studies that weren’t funded by the companies did show a significant increase in adverse events. What this underscores, yet again, is the importance of testing pharmaceutical products independently, by people who don’t have a vested interest in the outcome.

People who are thinking of taking these products must be aware of all of the potential risks beforehand. If you’ve taken any of these testosterone supplements and have suffered adverse consequences, including a heart attack or stroke, feel free to contact. You can also obtain additional information and contact us through www.androgellawyers.com. We will fight for you to obtain the compensation you need for your medical care and well-being.