In 1997 the FDA approved finasteride, a drug marketed by Merck under the label of Propecia and Proscar. Propecia and Proscar inhibit androgen conversion to testosterone, the male sex hormone. Originally used for the treatment of symptomatic benign prostate enlargement. This would decrease the problems of high testosterone such as male pattern baldness and prostate enlargement. In Merck’s 5 year testing they found 9 out of 10 men had improved appearances by visual assessment.
However, recently there has been multiple personal injury lawsuits filed against Merck due to serious side effects claimants have made, including:
- Heightened prostate cancer risk
- Gynecomastia (male breasts)
- Decreased arousal and libido
- Erectile dysfunction
- And more
The FDA made an announcement in June of 2011 requiring Merck to add new drug label warnings to Propecia. The FDA is also advising Healthcare professionals to be aware of the “warnings and precautions” sections of the labels for the 5-Alpha reductase inhibitor class of drugs which includes Propecia.
Interestingly, Merck updated the warnings for the United Kingdom, Sweden and Italy in 2008. Propecia sales are almost a half billion dollars a year and Merck’s patents don’t run out until 2013.
Lawsuits against drug manufacturers are very hard to win unless you can prove “failure to warn”. If you go to Propecia.com, the website is “currently not available” but encourages patients to report negative side effects to the FDA!
For San Francisco Bay Area gynecomastia surgery patients, it is very important to be aware of all drugs you are taking and inform your surgeon who will be trying to discover the cause of your gynecomastia and to determine your gynecomastia treatment.