FDA officials have called for changes to the product labels of two brand-name formulations of finasteride to reflect new information about adverse events that have been linked to use of these medications.
According to information posted on the FDA website(www.fda.gov), the products Proscar (finasteride 5 mg) and Propecia (finasteride 1 mg), both of which are marketed by Merck & Co. Inc., will each carry an expanded list of adverse sexual events on their respective package labels. In both cases, that listing will include information about effects that persist after discontinuation of the drug.
Proscar is indicated for treatment of symptoms in men with benign prostatic hyperplasia (BPH) and also is approved to reduce urinary retention risk or the need for surgery related to BPH. Propecia is approved for use only in men as a treatment for male pattern baldness.
Among specific changes the FDA is calling for are
- a revision to the Propecia label to add libido disorders, ejaculation disorders and orgasm disorders that continued after the drug was discontinued;
- a revision to the Proscar label to include decreased libido that continued after the drug was discontinued; and
- revisions to both drugs' labels that describe reports of male infertility and/or poor semen quality that normalized or, at least, improved after discontinuing the respective drug.
According to the agency, the changes were based on its review of hundreds of case reports of sexual dysfunction that persisted after patients ceased using the drugs. It should be noted that in 2011, the FDA called for both drugs' labels to be revised to include erectile dysfunction as a side effect that continued after discontinuation of the drug.
The FDA notes in its latest announcement that, "Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs."