Official: FDA has published labeling changes for Propecia (Finasteride 1mg)

Following a lengthy safety review, the FDA has mandated that Finasteride (Propecia, Proscar) must carry additional warnings regarding the possibility of persistent sexual side effects. The following text is now part of the propecia label:

"Postmarketing experience:
Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders;  male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain."

It's the first time FDA admits infertility problems and orgasm disorders related to Propecia The FDA also advises that they have started the process of notifying health care professionals who prescribe Finasteride (dermatologists, physicians, urologists and residents) on the revision and label changes.

To read the full article on the FDA website:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Propecia precribing information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf