January 31, 2013 — According to the most recent QuarterWatch report, the anti-baldness drug Propecia (finasteride) has been linked to an additional 61 “serious” adverse event reports in the last quarter of 2012. The report was created by the Institute for Safe Medicine Practices (ISMP), a non-profit group that monitors adverse event reports submitted to the U.S. Food and Drug Administration (FDA). The investigation found that 46 out of 61 reports involved sexual dysfunction, and 27 reports described sexual dysfunction that persisted after Propecia was discontinued.
The investigators found that 75% of the serious adverse event reports involved sexual dysfunction, despite the fact that sexual side effects from medications are rarely reported. They also found that about 46% of patients who reported sexual dysfunction filed their report before the side effect resolved. There were 20 reports of disabling sexual disorders, including:
- Penile curvature
- Testicular pain
- Scrotal pain
- Gynecomastia (male breast disorder)
- Testicular atrophy
- Reduced penile size
- Orgasm disorder (anorgasmia)
Although Propecia has been on the market for about 20 years, it has only been in the last few years that experts have raised concern about persistent, potentially permanent sexual side effects. These studies show that a drug with one purpose (curing baldness) can have severe detrimental effects on many other areas of the body and mind.
No one knows exactly how often persistent sexual dysfunction affects men who take Propecia. Merck has estimated the risk of non-persistent sexual dysfunction at 2%, and most experts agree that “persistent” effects are significantly rarer. However, the studies are all based on relatively small patient groups, and the actual incidence may be significantly higher than expected.
According to the report, the first indications of “persistent” sexual dysfunction were revealed in 2003 in a Merck-funded study that involved men given finasteride to treat enlarged prostate. The researchers found that sexual side effects occurred in 15% of men treated with finasteride, and only 7% of men who were given a placebo. By the end of the study, 50% of men had their sexual problems resolve. The other 50% of men with sexual problems were not tracked after the study ended.
It wasn’t until 2011 that researchers began investigating Propecia-induced sexual dysfunction and its persistent effects. A researchers from George Washington University, Dr. Michael Irwig, assessed 71 men who reported at least three months of persistent sexual dysfunction. After he followed up with them one year later, he found that 96% of the men still had symptoms.