Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury. In January, the FDA announced that it was investigating claims, in large part based upon reports of patients who have taken testosterone replacement drugs and then suffered heart attacks or strokes. In January the FDA issued a “Safety Announcement,” claiming that it is now monitoring the risks of Low T therapy to reassess its safety.

This should be alarming news for the over five million men in America who last year received prescriptions for testosterone and who fill nearly 13,000 prescriptions a day for low testosterone, a condition that occurs when the testicles fail to produce testosterone because of genetic problems, injury, or chemotherapy.

According to the medical literature, testosterone drugs should be used only by men who have a documented condition known as Low T, NOT simply as the anti-aging, sex-drive-increasing panacea depicted in hundreds of advertisements in magazines, on TV, and over the internet.
Low T can be diagnosed only by a series of blood tests.

Most people do not know that the warning labels on drugs are actually designed by the pharmaceutical companies that make the drugs; those labels must only be approved by the FDA. I am a lawyer who has sued drug companies for more than 20 years, and I believe, based upon these studies, that the FDA should now require Low T drugs to have a “Black Box” warning. As of today, the FDA has not required any Low T drug makers to change their packaging labels.

FDA Testosterone: Why Are They Not Protecting Us?

As a lawyer for low testosterone cases, I believe that as long as there is a known risk, there should be a warning. Consumers have a right to be protected by the FDA, even over-protected. Then, with all the available information in hand, we as adults can knowingly assume a risk, such as taking a dangerous drug by balancing the dangers against the benefits.

For the FDA to know of a danger and not force drug makers to share it with consumers is morally wrong and illegal. It is not in our best interest to continue to allow the FDA to rely on the multi-billion-dollar pharmaceutical industry–with its documented history of hiding the truth, and falsifying reports that have destroyed lives–to police itself.

The FDA’s refusal to require a Black Box warning simply renders the FDA an irrelevant spectator rather than the guardian of our well-being that we need. Americans need Seal Team 6 to protect us from drug companies, not just a school crossing guard.

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