March 5, 2012 — The U.S. Food and Drug Administration (FDA) is currently in the process of reviewing the safety of Propecia, according to an FDA spokeswoman. As part of the FDA Medwatch program, the organization collects Adverse Event Reports (AERs) and reviews them as part of routine safety surveillance. This updated review comes amidst growing numbers of men report that Propecia has caused severe, persistent sexual dysfunction that does not respond to treatment.
The FDA conducts routine drug safety surveillance based upon the AERs they collect via the Medwatch program. Injured people or their doctors submit reports of side effects caused by drugs or medical devices. The numbers of AERs typically under-estimate the actual number of injured people, because only a small number of injured people submit data. The FDA is able to identify serious risks, usually based upon groups of AERs, but also sometimes based on single reports. Since Propecia was approved in 1997, many men who have suffered severe Propecia side effects have issued reports. Even so, the FDA has not yet issued any safety communications regarding the link between Propecia or finasteride and sexual health or mental health problems.
There have been two scientific studies linking Propecia to sexual dysfunction and mental health problems. This may be why Merck & Co. recently pulled most of the content off the Propecia website. Some are asking whether Merck will include more safety warnings on the website, open up a hotline, or conduct more clinical safety trials. It is not known how many AERs Merck or the FDA have received, but many are hoping that these organizations will soon address safety concerns.
The evidence regarding the link between Propecia and sexual side effects has existed since the drug was approved. Merck knew that the drug could have sexual side effects. They estimated that 2-3% of men taking Propecia would suffer these side effects, but assumed the problems would resolve when the medication was stopped. Unfortunately, there is mounting evidence that this risk was underestimated, and the problems may not always resolve spontaneously.
Because millions of men have used Propecia (or Proscar, another medication containing finasteride), there may be tens of thousands of men who have suffered sexual side effects. Many of these men have complained that the side effects did not resolve when they stopped taking finasteride. Many of these men are now calling their condition “Post-Finasteride Syndrome,” which refers to a massive hormonal change in the brain that occurs soon after finasteride is stopped. Symptoms include depression, decreased libido, decreased sensation, persistent erectile dysfunction, decreased ejaculate volume, and erectile dysfunction. Furthermore, men may also suffer from changes to brain chemistry that cause depression and mood disorders.
In 2008, a Swedish study found that men who took Propecia were more likely to suffer persistent erectile dysfunction. Swedish health authorities required Merck to include this risk information in the safety labeling. Several other European countries soon did the same. In the United States, however, Merck waited until June 2011 to update safety labeling to include risks of persistent erectile dysfunction. The company’s action was voluntary.
Despite increasing numbers of AERs and two scientific studies regarding the link between Propecia and sexual side effects, the FDA has not issued a drug safety communication. Instead, the FDA has warned that finasteride could increase the risk of high-grade prostate cancer, and also male breast cancer.
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