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New Testosterone Warnings

Darrell Hulisz, RPh, PharmD
Sarah Lipperman,

December 1, 2016

The FDA recently approved label changes for all testosterone products to reflect new warnings of abuse and dependency. Prescribers will now be alerted by this new warning of potential abuse, adverse cardiac effects, and mental health concerns. These include an association between testosterone use and heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility. With the possibility of testosterone also comes the potential for withdrawal symptoms, including depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

The "Warning and Precautions" section on testosterone product labels has also been updated to advise prescribers to obtain total serum testosterone concentration levels in persons suspected of abusing the drug. The normal range of total testosterone for men is 280-1100 ng/dL.

Testosterone is a federal schedule III classification and carries abuse potential, most commonly in athletes and body builders. It can increase lean body mass and decrease fat mass. In the last 15 years, there has been a threefold increase in testosterone use worldwide. It is estimated that of 11 million men using testosterone legally, 51% are using it for hypogonadism, 35% for fatigue, 32% for erectile dysfunction and 12% for psychosexual dysfunction. However, the number of people using it worldwide is substantially higher when factoring in illegal use.

Testosterone is a hormone that is essential for the normal development of male features. It helps hair and lean muscle develop, causes the penis and testes to grow, and it also causes changes in puberty, such as deepening a boy's voice. The only FDA approvals for testosterone usage are hypogonadism in men, delayed puberty in certain boys, or metastatic breast cancer in select women. It is not recommended to be prescribed in men whose testosterone levels are declining due to aging alone due to increased risk of heart attack and stroke. Testosterone is available as a nasal gel, buccal tablet, pellet implant, intramuscular solution, transdermal cream, transdermal gel, transdermal ointment, transdermal patch, and transdermal solution. An additional warning for transdermal testosterone is secondary exposure, originally reported in children who were exposed by adults. Attached to the intramuscular injection is a black box warning of serious pulmonary oil microembolism (POME), in which reactions include anaphylaxis, chest pain, urge to cough, dizziness, dyspnea, throat tightening, and syncope.

The FDA advises health care professionals and consumers to report adverse reaction to the FDA's MedWatch Adverse Event Reporting program by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; and online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Pharmacists should include these new warnings when counseling patients on testosterone replacement therapy.

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