FDA Says Testosterone Therapy Provides Few BenefitsSep 5, 2014
The U.S. Food and Drug Administration (FDA) has indicated that little evidence exists that testosterone treatments for so-called “Low T” are beneficial.
Although the agency did not go so far as to indicate that the hormone products carry serious risks, two federally funded studies revealed ties between testosterone therapy products and cardiac problems in men, according to the Associated Press (AP).
Consumer advocacy group, Public Citizen, indicated that the agency’s review minimizes evidence of cardiac risks revealed in a number of studies on the testosterone products. Also, this February, Public Citizen petitioned the FDA to include a boxed warning—the agency’s most serious warning—on all testosterone drugs concerning potential cardiac risks. The FDA rejected the proposal; however, Dr. Sidney Wolfe of Public Citizen told the AP that information on the recent studies concerning heart risks will likely be added to testosterone drug labels.
"There will be a warning and once it happens the prescribing will drop way down, and that will be to the betterment of the public health in this country," Dr. Wolfe told the AP. He also pointed out that, Androgel prescriptions—Androgel is the top selling testosterone drug and is made by Abbott Laboratories—, have dropped 23 percent since July 2013.
Meanwhile, the two studies found that older men and men with pre-existing cardiac disease were likelier to suffer heart attack, stroke, or death if taking testosterone medication. The first of the two studies was published in the Journal of the American Medical Association (JAMA) last November, and involved older men. The research suggested increased risks for stroke, heart attack, and death were seen in men prescribed testosterone therapy. The second study, published in journal, PLoS, also suggested increased risks for heart attack in older men, and in younger men diagnosed with a pre-existing heart disease.
Approximately 2.3 million men in the United States received a prescription for testosterone in 2013, which is an increase of 77 percent from 2010, according to FDA figures, wrote the AP. Also according to the agency, more than 20 percent of these patients had no record that their testosterone levels were measured.
Current testosterone treatments include skin patches; short-acting injections; topical gels; and the buccal system, which involves application to the upper gum or inner cheek. Products include AbbVie Inc’s AndroGel, Androderm, Axiron, Bio-T-Gel, and Delatestryl. Endo International, previously known as Endo Health Solutions Inc., recently launched Aveed, Reuters reported.
The FDA’s review was posted in advance of a public meeting on the benefits and risks of treatments that increase testosterone levels. The federal regulators will be meeting on September 17 to ask a panel of outside experts if prescribing information on testosterone drugs should be revised to focus on a narrower patent group, wrote the AP. Panelists will also discuss the two studies and review if testosterone drug makers should conduct long-term follow-up studies to assess cardiac risks associated with the drugs, the AP reported.