Safety Alerts & Recalls

What does this mean?

For most patients, the benefits of using an FDA-approved testosterone product will continue to outweigh the risks. If you use testosterone replacement therapy, please continue to use it as directed by your healthcare provider. If you have concerns about this safety alert or if you have a history of blood clots in the leg (DVT) or lungs (PE), please speak with your healthcare provider. Your doctor can review the benefits and risks of your testosterone treatment and make changes if needed.

This safety alert is a good reminder that testosterone products have a small risk of causing blood clots in the veins of the legs or lungs. If you experience any of the following symptoms, please seek medical attention since they can be signs of a blood clot in the veins:

- swelling in one or both leg

- pain or tenderness in one or both legs, which may occur only while standing or walking

- warmth in the skin, or red or discolored skin of the leg

- visible surface vein

- leg fatigue

- sudden coughing, which may bring up blood

- sharp chest pain

- rapid breathing or shortness of breath

- severe lightheadedne

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 Adds Blood Clot Warning to Testosterone Products

All testosterone products approved by the Food and Drug Administration (FDA) will now include a general warning about the risk of venous blood clots. A venous blood clot, also known as a venous thromboembolism (VTE) is a blood clot that occurs in the veins. Types of venous blood clots include deep vein thrombosis (DVT) and pulmonary embolism (PE).

The risk of blood clots in the veins is already included in the prescribing information of testosterone products as a possible consequence of polycythemia, which is an abnormal increase in red blood cells that sometimes occurs with testosterone treatment. The FDA is requiring manufacturers to include a general warning in the prescribing information of testosterone products because there have been reports of venous blood clots occurring that are unrelated to polycythemia.

This new warning is not related to the FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products that was described in an FDA Drug Safety Communication posted in January 2014.

Testosterone is a hormone needed for the proper development of male sexual characteristics. Testosterone is also important for maintaining muscle bulk, adequate levels of red blood cells, bone growth, a sense of well-being, and sexual function. The FDA has approved testosterone products only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone due to genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary that control the production of testosterone by the testicles.

Some brand names of testosterone products are Androderm, AndroGel, Android, Axiron, Delatestryl, Depo-Testosterone, Fortesta, Metandren, Oreton, Striant, Testim, Testoderm, Testred, Virilon, and Vogelxo.

For more information, please visit: more information here

To view the MediGuard Safety Alert posted in January 2014, please visit: more information here

Source: FDA
Publication Date: 2014-06-24
Last Updated: 2014-06-25

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