FDA Updates Label Warning for Testosterone Medications

Defective Drugs

Recently, the US Food and Drug Administration (FDA) announced a nationwide label change that will affect both the Warning and Abuse and Dependence sections of many testosterone medications.

Testosterone, a Schedule III drug under the 1990 Steroids Control Act, has been associated with several serious side effects. Testosterone is found in anabolic steroids and can be used to treat hormone conditions and muscle loss from cancer or AIDS. However, testosterone has also been found to be addictive, and has dangerous withdrawal effects including:

  • Heart attacks and heart failure

  • Liver toxicity

  • Male infertility

  • Increased aggression

  • Depression

  • Fatigue

  • Insomnia

  • Loss of appetite

  • Decreased libido

Testosterone naturally declines after the age of 40, and some doctors may suggest using testosterone as a treatment. Although, the FDA recommends that patients and doctors use alternative methods of treatment as the full risks and benefits of testosterone in aging men has not been fully researched. One study, published by the Journal of the American Medical Association, showed that men who used testosterone over the age of 40 had a 30 percent higher risk of heart attack and stroke.

Testosterone Gel

Testosterone in gel form has been found to be the riskiest form of testosterone medication. Testosterone gels are applied directly to the skin and may pose a large health risk to others via secondary exposure. The FDA has given all forms of gel testosterone a blackbox warning for the risk of secondary exposure and the various side effects for women and children which are:

  • Enlargement of the genitals

  • Increased libido

  • Increased aggression

  • Fetal harm for nursing or pregnant women

  • Increased erections

  • Early development of pubic hair

  • Increased body hair and acne in women

  • Infertility

  • Enlarged breasts

  • Testicle shrinkage

  • High blood pressure

  • Increased risk of heart attack and stroke

  • Bone growth problems

Thousands of cases have been successful in litigation against manufacturers of testosterone medications, and cases are still being disputed in many districts. Litigation against testosterone manufacturers is usually a result of patients not being fully informed of the risks associated with the drugs.

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