FDA Moves to Stem Off-Label Testosterone Use

The FDA recently ordered drugmakers in the $1.6 billion testosterone-replacement therapy market to update their labels with warnings of the potential for increased heart attack risks when used for aging-related low testosterone.

TRTs are indicated to treat low testosterone levels associated with certain medical conditions and not for the common off-label use of raising levels in older men, the FDA says, adding the benefits and safety of prescribing these drugs to treat the symptoms of low testosterone associated solely with getting older have not been established.

The label update applies to all approved TRTs and aims to clarify their approved uses. TRTs such as AbbVie’s AndroGel (testosterone gel) are currently indicated for men with a deficiency caused by congenital or acquired hypogonadism.

In September, an FDA advisory panel recommended stiffer warnings on off-label use of TRTs. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee also has called for new warnings against the use of TRTs in men with severe health problems.

Your product is not approved for a particular use, but you promote that product off-label, perpetuating the nonapproved use. If patients are injured, it will be nearly impossible for you to disclaim responsibility for warning about an off-label use, especially after you’ve promoted the device or drug for that use. Learn what you need to know with The Impact of Off-Label Promotion on Product Liability.