In June 2011 the FDA issued a safety community that the generic drug finasteride, marketed as Propecia, is linked to an increased risk of high-grade prostate cancer. Propecia is a drug that is manufactured and marketed by Merck as a treatment for male pattern baldness. While the drug was originally developed to treat prostate problems in men, its effectiveness in treating male pattern baldness is what has made the drug famous.
But now, new studies call into serious question the safety of taking Propecia and other forms of finasteride marketed as Adovart and Proscar—and that is the reason for the recent FDA warning. That warning was based on a study involving Avodart and Proscar. Together, these three drugs are classified a 5-ARIs for the specific chemical and hormonal changes they cause in the body. But the FDA cites two large randomized studies that tried to assess the effect of these drugs on the likelihood of prostate cancer. What the researchers found is that the Avodart and Proscar decrease the incidence of lower risk forms of prostate cancer, but increase the risk of high-grade prostate cancer. High-grade prostate cancer is a rare but more aggressive cancer than low-grade prostate cancer.
Propecia has one-fifth the active ingredient as Proscar, leading the FDA to determine that Propecia should carry the same warning about the risk of high-grade prostate cancer. Thus, also in June of this year, the FDA required drug labels for Propecia to include more information regarding the risk of prostate cancer. While the FDA appears to think that the benefits of using Propecia to treat prostate problems outweigh the risks, the FDA continues to evaluate the risks and benefits of using Propecia to treat baldness.
Merck has previously claimed that in clinical studies for PROPECIA, a small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men and went away in men who stopped taking Propecia because of them. Clearly the new studies call these claims into question. Likewise, the older labels for Propecia had little to no information about the risks of prostate cancer. Already, some lawsuits have been filed against Merck as a result of Propecia’s potential connection with prostate cancer.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.