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March 8, 2018

FDA Increases Drug Warnings for Testosterone Medications

Testosterone Warnings And Other Drug Information Patients Need To Know

Men who are suffering from low testosterone due to medical disorders may be prescribed testosterone therapy. These medications can be taken many different ways, including gels, skin patches, intramuscular injection, time-release implants, or solutions applied to the gums or inner cheeks. While men nationwide may take testosterone supplements to combat low testosterone, many are unaware that the drug was never intended to correct age-related testosterone loss—and it could even place them at risk of severe injury.

tablet with testosterone displayed and stethoscopeFDA Warns Patients About Taking Prescription Testosterone

Testosterone therapy was originally approved by the U.S. Food and Drug Administration (FDA) as a treatment for men who have low testosterone levels due to certain medical conditions. Men with disorders of the testicles, damage to the reproductive system, or pituitary abnormalities may suffer hypogonadism, a condition that affects hormone levels or restricts activity in the testes. In recent years, however, prescription testosterone has increasingly been prescribed by doctors to combat the symptoms of low testosterone, or low-T, in older patients. The FDA has spoken out against this use of the drugs, stating that they were never intended to treat low testosterone due to aging and that it may not be safe to use these medications for that purpose.

The FDA has required that drug manufacturers take steps to ensure the safety and appropriate use of their testosterone medications by:

  • Changing labels. In 2015, the FDA issued a safety warning about the dangers of taking testosterone, urging doctors to prescribe testosterone therapy only for men whose low testosterone levels are a result of confirmed medical conditions. The agency also demanded that manufacturers of all approved prescription testosterone products update their labeling to clarify all approved and intended uses of the medication.
  • Addressing heart risk warnings. Several studies have concluded that there is an increased cardiovascular risk associated with testosterone use. While results concerning testosterone’s heart-related side effects may vary, the FDA does acknowledge an increased risk of heart attacks, strokes, transient ischemic attacks, congestive heart failure, and deaths associated with testosterone therapy. As a result, the FDA now requires the packaging of all testosterone products to warn about the possible risks of heart attacks and strokes, and advises doctors and health care professionals to make sure that patients are aware of their risks before beginning testosterone therapy.
  • Performing additional testing. The FDA has mandated that all manufacturers of approved testosterone products must conduct additional clinical trial testing to identify the risks of heart attacks and strokes for users of all ages. Manufacturers may work together or separately on this clinical trial, but the tests must be well-designed and the results clearly outlined.

Patients Taking Testosterone Should Know the Symptoms of Heart Attacks or Strokes

As the side effects can be life-threatening, patients using testosterone should seek medical attention as quickly as possible if they experience any early warning signs of a heart attack or blood clot, including chest pain, shortness of breath, weakness in one arm or along or one side of the body, sudden confusion, or slurred speech. Most studies indicate that cardiovascular risks of taking testosterone are higher for men over 50, with risks increasing with age. Side effects can occur within months of taking the drug and are possible as long as testosterone use continues.

If you or someone in your family suffered a heart attack or stroke as a result of taking testosterone, we can help. Lawsuits filed against the makers of these medications have claimed that the manufacturers boosted sales by marketing to older patients who did not need the drug—a group of consumers who were also most likely to suffer side effects. The McGartland Law Firm can investigate your claim and get you the compensation you deserve for your hospitalization and medical costs, and we do not collect legal fees unless we win your case. Call the number on this page today to speak to a legal representative about your claim.

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