More sexual side effects identified with finasteride
A TGA spokesperson said it was holding talks with sponsors to update PI after the US FDA announced changes to labelling earlier this month.
In 2011, both Proscar and Propecia’s labels were revised to include erectile dysfunction that continued after drug discontinuation.
But the list of libido and ejaculation disorders has now been expanded, the FDA said.
The changes involve Propecia, indicated for male baldness, and Proscar, indicated for symptomatic benign prostatic hyperplasia with enlarged prostate.
The Propecia label in the US would be updated to cite “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug”, the FDA said.
Proscar’s label would cite “decreased libido that continued after discontinuation of the drug”.
Labels on both drugs were being revised to “include a description of reports of male