Propecia is one of several prescription drugs called “5-alpha reductase inhibitors (5-ARI)” used to treat hair loss and pattern baldness in men. Pending lawsuits allege that Merck, the drug company that makes Propecia, failed to warn consumers of permanent sexual side effects. The cases claim that the drug was not thoroughly researched and Merck withheld information from health care providers and consumers. Although Merck acknowledged potential sexual side effects, they maintained these problems would go away when the drug was discontinued. However, in April 2011 Merck changed the label to include information about “reports of erectile dysfunction that continued after discontinuation of Propecia.” The label also includes a warning that in “rare cases” users of propecia have developed breast cancer.
In June 2011 the FDA required the warning labels on Propencia and several other 5-ARI drugs to include information on the increased risk of high-grade prostate cancer. The FDA has yet to take action in response to rising concerns over reports linking Propecia to permanent sexual side effects. Information about these potential side effects have been well publicized in Europe for several years. As far back as 2008 Sweden demanded that Merck add reports of “persistent erectile dysfunction” to the label.
The recent removal of the Merck-sponsored website, Propecia.com, has sparked speculation about a possible recall. The promotional website has been replaced with prescription information, refund request procedures related to the Propecia Promise Program, and information on how to report adverse side effects to the FDA.