FDA adds abuse warning to testosterone product labels

The Food and Drug Administration Tuesday issued labeling changes for all testosterone products, adding a warning to prescribers about the drug’s potential for abuse.

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The revised labels will also contain new information in the abuse and dependence section about adverse effects of abuse, including heart attack, stroke, depression and infertility. Individuals who abuse testosterone may experience withdrawal symptoms like fatigue, loss of appetite and insomnia, according to the report.

The FDA approved testosterone products as hormone replacement therapy for men who have low testosterone as a result of certain medical conditions.

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