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EARLY ADVERSE EVENT REPORTS SURFACING IN PROPECIA LITIGATION

EARLY ADVERSE EVENT REPORTS SURFACING IN PROPECIA LITIGATION

Freedoms of Information Act (FOIA) requests were recently brought seeking information regarding adverse event reports received by the Food and Drug Administration (FDA) about Propecia. Propecia was approved by the FDA in 1997 as a treatment for males for hair loss. Through FOIA it has been discovered that an early adverse event was reported to the FDA in October 2000 associating the use of Propecia, with an incident of potential male infertility after Propecia use.

According to the  report, information was received from a 30 year old male who in September 1997  was placed on therapy with Propecia, (Finasteride), tablet, 1 mg, once a day for the treatment of hair loss.    In July of 2000, the man had a semen level test done and his sperm count was low.  In August 2000, Propecia was discontinued.  Subsequently the man had a second semen level test and his semen level had not improved.

Information was also received through FOIA from a 39 year old male who was prescribed Propecia in January 1999. In 1999, the man reported difficulty achieving an erection and pain in his penis when sexually aroused. Up and down motion during intercourse was excruciating and made intimacy impossible. The man also reported a change in the shape of his penis with areas that appeared to be sunken. Propecia was discontinued in August 2009 but the change of the man’s penile shape and sexual dysfunction continued.

From November 1997 to September 2011 the FDA received thousands of reports of reactions related to the use of Propecia. These reports included reactions such as dizziness, nausea, fatigue, drug ineffective, dyspnea and sexual dysfunction. Merck did not include warnings of persistent sexual dysfunction as a side effect of Propecia until mandated by the FDA in April 2012.

Oracle Law Group has experienced personal injury lawyers that can help investigate and pursue product liability claims. Currently, Oracle Law Group is investigating claims that Propecia caused permanent male sexual dysfunction. If you or someone you love has suffered an injury from Propecia, our trained personal injury attorneys can help you or your loved one recover compensation. Call Oracle Law Group today to talk to a Propecia lawyer for a free consultation.