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1996 – Study links finasteride and sexual side effects long before warning labels updated

Posted in Propecia / Proscar

Though the warning labels for Propecia (finasteride 1mg) and Proscar (finasteride 5mg) were not updated to include information about long-term sexual side effects until April, 2012, research has been available to the public for over a decade that shows finasteride is connected with such adverse effects.  Here, we discuss an article appearing in the November, 1996 edition of Canadian Medical Association Journal titled “Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.” by J.C. Nickel et al.

The objective of this research was to “evaluate the efficacy and safety of 2 years’ treatment of moderate benign prostatic hyperplasia (BPH) with finasteride” and consisted in a double-blind, placebo-controlled study.  This means that neither participants nor researchers knew whether drugs administered were placebo or real, so neither participant nor researcher bias could confound results.

In all, 472 men aged 45-80 completed the two-year study.  “After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years.”

While symptoms of benign prostatic hyperplasia and size of prostate decreased with finasteride treatment and urinary flow rate increased, “the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters).”

Due to the fact that the manufacturers of Proscar failed to update warning labels and inform patients of the risks associated with the drug, a number of Proscar lawsuits have been filed.  If you or a loved one used Proscar and suffered sexual side effects, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Proscar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us