Health Fears Prompt FDA to Mandate Change in Testosterone Labeling


The Food and Drug Administration (FDA) recently announced that it will require prescription testosterone manufacturers to label the drugs to warn users that they might face a higher risk of heart attacks and strokes. The agency also ordered the drug makers to list the approved uses of testosterone medications on their products.

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The use of testosterone medication has risen sharply. In 2010, there were 1.3 million patients using testosterone medication. By 2013, that number rose to 2.3 million, a 76% increase in three years.

Cardiovascular risks

The FDA made its decision about labeling for heart attack and strokes from testosterone use based on input at a committee meeting. The agency is also requiring testosterone manufacturers to do a clinical trial on increased cardiovascular risks.

In the meantime, the FDA alerted testosterone therapy patients to seek immediate care if they experienced one of the following symptoms:

  • Chest pain
  • Shortness of breath
  • Slurred speech
  • Weakness in one body part or on one side of the body

Approved uses

New testosterone warning labels will have to state the approved uses of the medication. Men have low natural testosterone levels for various reasons, and the FDA has approved testosterone medicine to treat low levels occurring because of certain conditions, such as:

  • Genetic disorders
  • Chemotherapy
  • Infection

Specifically excluded is aging, a common reason men seek testosterone treatment. In fact, research from 2010-13 found the most common diagnostic code associated with testosterone therapy is “testicular hypofunction, not elsewhere classified,” or not related to a specific medical disorder. The safety of those using testosterone treatments for this reason is currently being questioned and researched by the FDA.

Slack & Davis’ pharmaceutical lawyers can help if you or a family member has suffered serious health consequences from use of testosterone or other prescription drugs. We have won favorable judgments for our clients based on our knowledge and skill at trial. If you have questions about personal injury from medications or want to speak to a pharmaceutical lawyer, call Slack & Davis today. Our firm will give you and your family the highest quality legal assistance, so you can have a better piece of mind.