Finasteride Toxicity Information: Limited, Poor Quality, Biased

A meta-analysis conducted by US-based researchers found that the available toxicity information from clinical trials of finasteride in men with androgenic alopecia (AGA) is "very limited, is of poor quality, and seems to be systematically biased". None of the 34 clinical trials assessed met the criteria for adequate safety reporting, and 69% of men prescribed finasteride at doses of ≤1.25 mg/day did not meet the exclusion criteria for the 3 clinical trials that supported FDA approval of finasteride, 1 mg daily, for AGA. Funnel plots used to assess the odds ratio of sexual adverse events were all asymmetric with a bias towards lower odds ratios, suggesting possible under-detection or under-reporting of such events.