FDA Panel Votes Against Approving Oral Testosterone Replacement Products
The committee’s panel members were not concerned with the effectiveness of the oral testosterone treatment. Rather, they cited concerns over potential cardiovascular risks. In trials for both Jatenzo and Tlando, patients had upward shifts in blood pressure as measured by blood pressure cuffs. The panel said this method of measurement led to insufficient data to reach conclusions about the risks.
The FDA has previously addressed concerns over cardiovascular risks with testosterone-replacement therapy. In 2015, the FDA issued a warning requiring prescription testosterone replacement product labels to include notice of a potential increased risk of heart attacks and strokes. The FDA warning also said that drug manufacturers would have to perform trials assessing these risks, and that doctors should inform patients of the potential risks to patients interested in testosterone-replacement therapy.
In addition to cardiovascular risks, the panel was concerned about having a system in place to cut back on off-label use for the drugs that could expose patients to unnecessary risks. For example, an injectable form of the testosterone is only available through a risk evaluation and mitigation strategy (REMS). This is an FDA safety strategy used to manage known or potential serious risks associated with a medicine and restrict its use.
Both oral testosterone agents were seeking approval to treat hypogonadism, not age-related low testosterone. The FDA said that hypogonadism is the only valid cause to seek testosterone-replacement therapy.