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In the PROSCAR Long-Term Efficacy and Safety StudyPLESSa 4-year controlled clinical study3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years1524 on PROSCAR 5 mg/day and 1516 on placebo3.757 patientstreated with PROSCAR 5 mg and 2.132 patientstreated with placebo discontinued therapy as a result of adverse reactions related to sexual functionwhich are the most frequently reported adverse reactions.
Although Propecia is not for use by womenthis medication can cause birth defects if a woman is exposed to it during pregnancyPropecia tablets should not be handled by a woman who is pregnant or who may become pregnantPropecia tablets are coated and will prevent contact with the active ingredient during normal handlingprovided that the tablets are not broken or crushedIf a woman accidentally comes into contact with this medication from a broken or crushed tabletwash the area with soap and water right away.
No adjustment in dosage is necessary in non-dialysed patients with renal impairment.
The following adverse reactions have been identified during post approval use of PROPECIABecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
In June 2011the FDA released a safety announcement warning that Propecia and other 5-alpha-reductase inhibitors may increase the risk for high-grade prostate cancerthe deadliest form of prostate cancer.
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propecia 1 mg finasteride was approved by the fda for the treatment of male pattern baldness in december 1997.