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After Approval, FDA Decides to Give Low-Testosterone Drugs a Second Look

September 17, 2014

This past June, in an article about a potential link between testosterone treatment and cardiovascular problems, we explained that the FDA had (after about ten years of urging by researchers) decided to launch an investigation into the matter.

It turns out that it only took a few months for our nation’s drug regulators to suspect that these risks may not outweigh the benefits that low-T drugs formerly promised. In a newly released set of background documents, FDA researchers (though they insist that such materials do not constitute “the final position” of the FDA’s review board) admit that despite finding “insufficient evidence to conclude that testosterone therapy in older men was associated with an increased risk of adverse CV [cardiovascular] outcome” in 2010, they have “decided to reassess the potential risk.”

To be frank, studies have been inconclusive, which we may observe by simply searching the web for news stories about testosterone and heart risk. The Wall Street Journal, for example, ran stories titled “Testosterone Therapy Tied to Heart Risks, JAMA Study Shows” and “Testosterone Use Doesn’t Increase Heart Risks, Study Finds” less than eight months apart from one another. But the FDA’s decision to re-investigate this matter–along with the fact that any evidence of patient harm is troubling–suggests that the treatment’s potential dangers have researchers second-guessing themselves. This is especially true given the agency’s relatively poor track record when it comes to post-market oversight of drugs it initially approved, like Vioxx and Fen-phen, both of which were eventually pulled from pharmacies due to potentially lethal long-term side effects.

Though clinical trials and studies have not proven definitive, two recent studies, one in November 2013 and one in January 2014, suggest a threat exists. The first concludes that older men with existing cardiovascular problems face a higher risk of heart attack, stroke, and death when given supplemental testosterone. The second, perhaps more troublingly, concluded with the claim that among both younger and older men, “the evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events, including non-fatal myocardial infarction.”

While negative side effects may or may not exist when it comes to testosterone treatment, the FDA has rightly observed that many men are being treated with medications like AndroGel, Testim, and Axiron without having been diagnosed with anything related to low testosterone. In fact, only about half of the men prescribed such medications have actually been diagnosed with hypogonadism. And even more startlingly, about 25 percent did not even have their testosterone levels tested before being placed on a testosterone-boosting course. This is becoming increasingly relevant as the number of men between the ages of 40 and 65 taking low-T drugs has spiked from around 850,000 in 2010 to 1.5 million three years later.

Though they claim that their investigation directly relates to overprescribing, the good news is that the FDA is taking an increased interest in the potentially deadly effects of testosterone treatment in men. This is an all-too-rare example of the agency admitting it may have been wrong the first time around and following up on its initial approval.

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