Testosterone Label Change required by FDA

androgel-bottleA testosterone label change has been required by the FDA. In a March 3, 2015 safety announcement, the agency said that it was requiring the label change to inform users of a possible increased risk of heart attack and stroke. The agency also issued an announcement to caution against using testosterone (or Low T) products for low testosterone due to aging.

Testosterone Label Change required

“Testosterone product labels have been updated,” the agency announced. “The revised labels clarify the approved uses of Low T or testosterone therapy medications and include information about a possible increased risk of heart attacks and strokes in patients taking testosterone.”  This information updates the agency’s  January 31, 2014 Drug safety communique – “FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products.”

Low T only for Men with Low Testosterone

The FDA further announced that the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone:

“We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.

Hypogonadism only Approved Condition

The agency also said that it approved testosterone only as replacement therapy for “men with low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection.” The agency has become aware, however that testosterone therapy treatments are being used abundantly in men to relieve symptoms of low testosterone for no reason other than aging, though “the benefits and safety of this use have not been established.”

FDA: Possible Increased Cardiovascular Risk

The agency also said that evidence from published studies and expert feedback from an Advisory Committee meeting concludes a possible increased cardiovascular risk is linked with testosterone use. The examined studies included men treated with testosterone for aging, with some reporting “an increased risk of heart attack, stroke, or death associated with testosterone treatment.”

FDA wrote that based on its findings it was “requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.” The agency also told health care professionals to alert patients of this possible risk in deciding whether to start or continue  testosterone therapy. FDA said it is also “requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.” FDA said it is encouraging Low T makers to work together on a clinical trial, but will allow them to work separately if they wish.

The FDA also advised patients using testosterone to seek immediate medical help for heart attack or stroke symptoms, which include

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech

Report Testosterone Side Effects

A list of FDA-approved testosterone products can be found under a search for “testosterone” at Drugs@FDA. The FDA also urges health care professionals and patients to report side effects from testosterone products to the FDA MedWatch program.



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