Gynecomastia associated with calcium channel blocker therapy

Area of Science:

• Pharmacovigilance
• Endocrinology
• Drug Safety

Background:

• Gynecomastia is typically not associated with calcium channel blocker (CCB) therapy.
• The US Food and Drug Administration (FDA) monitors adverse drug reactions.

Purpose of the Study:

• To investigate a potential association between calcium channel blocker use and the development of gynecomastia.

Main Methods:

• Analysis of spontaneous adverse event reports submitted to the FDA's Division of Epidemiology and Surveillance.

Main Results:

• Thirty-one reports of gynecomastia were identified following the use of CCBs.
• In two cases, gynecomastia led to surgical intervention prior to drug discontinuation.
• Elevated prolactin levels were noted in two patients, suggesting a potential, though unconfirmed, mechanism.

Conclusions:

• A possible association between calcium channel blockers and gynecomastia should be considered.
• This potential link warrants clinical consideration to avoid unnecessary investigations or procedures.