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FDA Requires New Warning Label for Testosterone Drugs Dangers

476804939-testosteroneMakers of Low-T Medications Must Tell Patients About the Risk of Heart Attacks and Strokes

The FDA is warning doctors that testosterone medications such as AndroGel, Testim, Axiron should no longer be prescribed to men suffering from age-related Low-T. Drug makers will be required to study dangerous side-effects of the drugs.

Testosterone replacement gels, patches and injections were approved by the U.S. Food and Drug Administration (FDA) in the 1950’s to treat men with low testosterone levels related to medical problems, such as damaged testicles pituitary gland disorders, genetic causes or chemotherapy.

However, these medications are commonly prescribed to help men maintain testosterone levels as they age, a use that was never approved by the FDA but is heavily advertised by drug companies. Thanks to commercials that discuss “Low-T”, prescriptions for testosterone drugs for men age 40 and older have tripled. This surge in prescriptions has been very profitable for pharmaceutical companies. The market for prescription testosterone products exceeded $2 billion in U.S. sales in 2013.

While many men swear that testosterone  products have given them a new lease on life, there is a dark side to the drugs.

FDA Reacts to Studies Documenting Testosterone Dangers

A 2013 study in the Journal of the American Medical Association showed a 30% increased risk of death, heart attack, or stroke caused by artery blockage in men treated with testosterone, compared with those who did not take testosterone replacement drugs.  A separate study, conducted by the National Institutes of Health (NIH), found that men over age 65 who take testosterone products have double the rate rate of heart attacks as men not taking the drugs. The study was published in the journal PLOS One.

These studies spurred an FDA investigation on the safety of testosterone treatments. In September, an FDA advisory panel recommended changing the labels for testosterone replacement therapy to reflect cardiovascular risks. The panel also recommended that the FDA require further study of these risks.

On Tuesday, March 3, 2015, the FDA took a stand to protect patients. The government agency announced that there’s no good evidence that testosterone can help counteract the effects of aging and announced that the drug should not be prescribed to counteract age-related decrease in testosterone. The FDA is also requiring drug makers to warn patients that testosterone products may have dangerous cardiovascular side-effects, including an increased risk of stroke and heart attack.

Summary of the FDA’s Testosterone Product Warning

  • The benefit and safety of testosterone replacement medications has not been established for treatment of low testosterone levels due to aging.
  • Drug makers must state this fact on the labels and instructions for testosterone products.
  • Drug makers must warn of cardiovascular risks associated with testosterone medications.
  • Drug companies are required to conduct additional studies to better determine the risk of cardiovascular side-effects of testosterone.

Is this enough? Public Citizen’s, a non-profit consumer group, says the FDA should have issued a stronger warning. The group would like to see a black box warning on all testosterone drugs. A black box warning is used when there is reasonable evidence that a drug can cause serious injury or death.

The Drug Safety Lawyers hold drug makers accountable for medication injuries. We are currently investigating testosterone replacement drugs. If you suffered a heart attack or stroke while undergoing testosterone therapy, you may be eligible to take part in a lawsuit against the drug company. To learn more about your rights and AndroGel lawsuits, please call 888-808-1340.  Tell the operator that you’d like to schedule a free case evaluation. There is no obligation.


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