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Wednesday, August 13, 2014

FDA Announcement on Testosterone Therapy

At its May 2014 meeting, the Medical Board discussed the topic of testosterone therapy. The Board wishes to highlight this emerging health care issue, share information about an announcement by the FDA and mention relevant Board rules.

On January 31, 2014, the U.S. Food and Drug Association (FDA) issued a safety announcement that alerted the public that the FDA is “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” The FDA, which stated that although it had previously been monitoring the risk related to Testosterone products, it decided to “reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”

The safety announcement stresses that the FDA has not concluded that FDA-approved testosterone increases the risk of stroke, heart attack, or death, and that patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care providers. What the FDA safety announcement does mean is that:

  • The FDA is studying the issue of increased risk of stroke or heart attack death in men taking FDA-approved testosterone products;
  • Health Care professionals should consider whether the benefits of FDA-approved Testosterone treatments is likely to exceed the potential risks of treatment;
  • Prescribing information in the drug labels of FDA-approved testosterone products should be followed;
  • Testosterone products are FDA-approved only for use in men who lack or have low testosterone in connection with an associated medical condition. Examples of medical conditions include failure of testicles to pro-duce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with the hypothalamus and pituitary, brain structures that control the production of testosterone by the testicles.
  • The FDA is urging health care professional and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.

Source: Texas Medical Board