Product Liability: FDA Investigating Risks in Approved Testosterone Products

The Food and Drug Administration (FDA) has issued a Safety Announcement, saying that the agency is investigating the risk of stroke, heart attack and death from FDA-approved testosterone products, including Androgel, Androderm, Axiron, Bio-T-Gel, Delastryl and others.

The FDA said that it is reassessing the safety of these products based on two separate studies – one of which was published in the Journal of the American Medical Association (JAMA) in November 2013 – that suggests men taking prescribed testosterone products may have an increased risk of cardiovascular events.

Currently, testosterone therapy is only approved by the FDA for use in men who have been diagnosed with low testosterone levels and who suffer from an associated medical condition.  Testosterone products have not been approved for use in patients with low testosterone who have no other related medical conditions.  However, the prescribing of testosterone products for men with low testosterone due only to age-related conditions or declines in testosterone levels with no associated medical condition has continued to increase in the U.S.

One recent study of older men in the U.S. Veterans Affairs health system that was published in the November issue of JAMA suggested a 30% increased risk of stroke, heart attack and death among the study group of men 60+ years of age that had been prescribed testosterone therapy.

The other study, which looked at older men and younger men with pre-existing heart disease, found that the risk of heart attack doubled for men 65+ in the first 90 days following the first prescribed dosages of testosterone.  The heart attack risk among the younger group of men with pre-existing heart disease was 2-3 times greater in the first 90 days of the first prescription. 


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