January 31, 2013 — According to the Institute for Safe Medicine Practices (ISMP) QuarterWatch report, the anti-baldness drug Propecia (finasteride) has been linked to 61 serious adverse events in the last quarter of 2012. Of these, 46 reports involved sexual problems, and 27 reports involved possibly persistent side effects. The review found that 75% of “serious” Propecia side effects involved sexual dysfunction, which is remarkable considering that voluntary reporting of sexual side effects from medications is relatively uncommon.
The report also found that 28/61 reports (46%) involved side effects that did not resolve by the time the report was prepared. The side effect was described as a “permanent disability” in 20/28 reports. The severe side effects listed in the reports included the following side effects:
- Penile curvature
- Testicular pain
- Scrotal pain
- Gynecomastia (male breast disorder)
- Testicular atrophy
- Reduced penile size
- Orgasm disorder (anorgasmia)
In the 20-year history of Propecia, adverse event data has shown that a drug intended for one purpose (treating baldness) can have many complex adverse effects (sexual dysfunction, physical disfigurement, etc.). Studies of Propecia have also found that these adverse effects may not be discovered for many years, because they can take years to develop.
According to QuarterWatch, experts still do not know how frequently persistent sexual side effects occur with Propecia. The drug manufacturer, Merck & Co., has estimated the incidence of sexual dysfunction at 2% and found that persistent sexual dysfunction is even less common. However, because studies are based on limited data, the actual incidence may be significantly higher.
The report indicated that Merck-funded studies of Propecia found evidence of persistent sexual dysfunction as early as 2003. That study involved men who were given finasteride to treat enlarged prostate. In the first year of treatment, 15% of patients reported a sexual side effect, compared to just 7% of placebo patients. The researchers found that sexual problems resolved in 50% of patients who stopped taking the drug. However, the researchers never followed up with the other 50% of patients who still had sexual problems at the end of the study. The authors concluded that the persistent sexual problems were unrelated to the drug.
The link between Propecia and persistent sexual dysfunction was highlighted in a study published in 2011 by Dr. Michael Irwig of George Washington University. He assessed 71 patients (age 21-46) who used finasteride and reported at least three months of persistent sexual dysfunction. He found that the persistent sexual dysfunction lasted for an average of 40 months. Approximately one year later, he contacted 51 participants and found that 96% of them still had sexual problems.
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