FDA Panelists Vote to Adjust Testosterone Drug Labeling
A U.S. Food and Drug Administration (FDA) panel of advisers voted Wednesday to adjust labeling on prescription testosterone treatments to remind men that they are not approved to treat low libido, fatigue and other symptoms of aging.
At a meeting held on September 17th to discuss risks of AndroGel, Testim and other hormone-raising therapies, advisers for the agency agreed 20-1 that prescribing language regarding their use should mention that they have not been proven to treat low libido, fatigue and muscle loss. If the label change causes men to only take the medications for their FDA-approved use, which involves the treatment of hypogonadism, a condition referring to abnormally low levels of the hormone due to injury or disease, fewer men may take them.
An FDA panelist from Georgia Regents Medical Center said the current warning label on testosterone drugs leaves room for error. “I think the current labeling is vague and has been subject to misinterpretation,” an FDA panelist said.
Problems with testosterone treatment prescriptions may not be necessarily remedied with a product label change, however, especially since manufacturers pour millions each year into advertising their medications. AbbVie and Eli Lilly are just a few of the drug companies that market their hormone-raising drugs as a means of treating a condition referred to as “Low T” that can manifest in sexual dysfunction, low mood and other symptoms common to the aging process.
These efforts have resulted in a surge of testosterone drug scripts written to men in the U.S. According to drug data firm, IMS Health, the number of prescriptions written for testosterone drugs has grown 58 percent since 2010, with more than 4.8 million receiving the treatments last year.
FDA Says Testosterone Heart Attack Evidence is ‘Inconclusive’
At the FDA meeting in September, panelists also discussed a possible association between prescription testosterone therapies and the risk for strokes, blood clots, heart attacks and other serious cardiovascular injuries. The FDA first warned about this link in a public health warning issued in January 2014, after two studies found an increased heart attack risk in younger men with a pre-existing history of heart disease and all men over 65.
Panelists said in September that evidence proving this link remains “inconclusive,” and that drug companies should be ordered to conduct long-term research of their testosterone drug’s heart impacts.
That recommendation likely does little to assuage plaintiffs in testosterone drug lawsuits against the makers of AndroGel, Testim, Axiron and other products. In a federal multidistrict litigation now underway in the U.S. District Court, Northern District of Illinois, at least 170 claims alleging strokes, blood clots and other life-threatening heart problems have been centralized for pretrial proceedings.
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