IPLEDGE program
Although the goal of the program is to prevent pregnancies of women who take the drug, male patients must also participate in anti-pregnancy restrictions, primarily due to fears that male isotretinoin users might share their prescriptions with females without their physicians' knowledge. There has been no link to birth defects from Accutane associated with males using the drug, though male sexual dysfunction has been suggested by one study. As this has not been conclusively proven, this is not acknowledged as a side effect in the official literature accompanying the medication.
Medical uses of bicalutamide
Bicalutamide has a small risk of elevated liver enzymes and hepatotoxicity at dosages of 50 mg/day and above. As a result, it is recommended that liver function tests periodically be performed. The risk of elevated liver enzymes and liver failure with bicalutamide appears to be much smaller than with cyproterone acetate, which is the most widely used antiandrogen in transgender women in Europe and elsewhere in the world. In the United States, one of the only countries where cyproterone acetate has not been approved for medical use, the relatively weak and non-selective antiandrogen spironolactone is commonly used in transgender women instead. Bicalutamide is a favorable alternative option to these antiandrogens in transgender females.