Baldness drug Propecia and prostate drug Proscar get labeling change for sexual side effects

The U.S. Food and Drug Administration (FDA) has announced that labeling for the prescription drugs Propecia® and Proscar® will be updated to include information about sexual side effects that could persist after discontinuing the drug.

Physicians prescribe Propecia (finasteride 1mg) for the treatment of male pattern hair loss and Proscar (finasteride 5mg) for treatment of symptoms of an enlarged prostate condition called benign prostatic hyperplasia (BPH). The pharmaceutical company Merck & Co., Inc. manufactures both drugs.

More than a million men have used Propecia since it came on the market in 1998.

Labeling changes include:

• The Propecia labeling will include libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug.
• The Proscar labeling will include decreased libido that continued after discontinuation of the drug.
• The labeling on both drugs will also now warn of reports of male infertility and/or poor semen quality that normalized or improved with discontinuation of the drug.

Previous Propecia labeling said sexual side effects were reversible and disappeared after discontinuation of the drug.

Dr. Anthony D'Amico, of Brigham and Women's Hospital in Boston, told HealthDay News that the revised labels contain "an important message that people need to hear."

“Particularly because Propecia is used by 20- and 30-year-olds for hair loss and these are people of childbearing age, so if they are getting issues with fertility that a big issue,” D'Amico said.

The FDA said the Propecia labeling change comes after reviewing 421 postmarketing reports of sexual dysfunction submitted to the agency between 1998 and 2011. In 59 cases, erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders persisted for at least three months after men stopped taking the drug. The agency also reviewed sexual dysfunction reports for Proscar that resulted in the labeling change.

“Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs,” the FDA said.

The FDA did not review any new clinical studies in the evaluation of the sexual side effects.

However, a study entitled Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss appeared in the June 2011 issue of the Journal of Sexual Medicine. In the study, Dr. Michael S. Irwig, of The George Washington University, and Swapna Kolukula MB, BS of Greater Baltimore Medical Center conducted interviews with 71 between 21 and 46 years of age who were otherwise healthy but reported new onset of sexual side effects with Propecia use. Twenty percent of men in the study reported experiencing sexual dysfunction more than five years after they stopped taking the medication.

“Twenty percent of patients I interviewed experienced persistent sexual dysfunction for more than five years, which makes me wonder if their persistent sexual dysfunction is permanent,” said Dr. Irwig.

There are alternatives to Propecia for treatment of male pattern hair loss, including Rogaine (minoxidil) and surgical hair restoration.

“FDA believes that finasteride remains a safe and effective drug for its approved indications,” the FDA said. “Healthcare professionals and patients should consider this new label information when deciding the best treatment option.”