Safety Alerts & Recalls
What does this mean?
The FDA is warning that the benefits and safety of testosterone used to relieve symptoms in men who have low testosterone for no apparent reason other than aging have not been established. The FDA is also warning about the possible increased risk of heart and stroke associated with the use of testosterone products.
For men using testosterone to treat low testosterone levels caused by certain medical conditions, the benefits of using an FDA-approved testosterone will continue to outweigh the risks for most patients. Please continue to use it as directed by your healthcare provider.
Be aware that testosterone has been associated with an increased risk of heart attack and stroke. You should seek medical attention immediately if you experience symptoms of a heart attack or stroke, such as:
--- Chest pain
--- Shortness of breath or trouble breathing
--- Weakness in one part or one side of the body
--- Slurred speech
If you have concerns about this safety alert or if you have a history of heart attack or stroke, please speak with your healthcare provider who can review the benefits and risks of your testosterone treatment and make changes if needed.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: http://www.fda.gov/Safety/MedWatch/default.htm
FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Possible Increased Risk of Heart Attack and Stroke
The Food and Drug Administration (FDA) has issued a Drug Safety Communication to caution that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. Examples of such conditions include failure of the testicles to produce testosterone due to genetic problems or chemotherapy, as well as problems with brain structures (the hypothalamus and pituitary) that control the production of testosterone by the testicles.
The FDA has become aware that testosterone is being used extensively to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of testosterone 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.
Testosterone levels can decrease naturally with age, and sometimes can become lower than the normal range seen in young healthy men. Older men can experience decreases in energy levels and problems with sexual function. It is uncertain whether these symptoms are caused by low testosterone levels or due to normal aging; therefore, the need to replace testosterone in these older men is unclear.
Also, based on a review of the available evidence from published studies and input from experts, the FDA has concluded that there might be an increased risk of heart attack and stroke associated with testosterone use. These studies included older men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.
The FDA will require makers of prescription testosterone products to clarify the approved uses on the product label and include information about the possible increased risk for heart attack and stroke with use of these products.
Some brand names of testosterone products are Androderm, AndroGel, Android, Axiron, Aveed, Delatestryl, Depo-Testosterone, Ditate-DS, Fortesta, Metandren, Natesto, Oreton, Striant, Testim, Testoderm, Testopel, Testred, Virilon, and Vogelxo.
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