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Finasteride Sexual Side Effects Prompt FDA Warning, Label Changes
Effects Can Linger Even After Drug Is Discontinued
By News Staff
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.
- 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.
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."