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The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldnessBecause the event is reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure:

The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiencesIn additiondirect comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient populationdosage or dose regimenand other procedural and study design elements.

PSA levels are commonly used in the screening process for prostate cancerPatients who develop sustained increases in PSA while on finasteridethe active ingredient contained in Proscartherapy should be carefully evaluated for medical causes as well as noncomplianceRef]

Most men were older and were taking concomitant medications and/or had comorbid conditions:

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