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FDA Announces Sexual Side-Effects Labeling Changes for Two Drugs

Jul 13, 2012

Propecia bottle, cc-by flickr user ryan from Portland, OR

The U.S. Food and Drug Administration (FDA) has announced professional label changes for two drugs because of sexual side effects.
 
The two drugs are Propecia and Proscar. Both drugs are classified as 5 alpha-reductase inhibitors and contain finasteride as their active ingredient. Propecia is prescribed for male pattern hair loss. Proscar is used to treat problems caused by an enlarged prostate. 
 
On its list of “sexual adverse events”, the Propecia label will now include libido disorders, ejaculation disorders, and orgasm disorders that continue after stopping the drug. 
 
Proscar will list decreased libido that may last after drug treatment.
 
Both labels will also include information on male infertility and poor semen quality. However, these issues returned to normal or improved after stopping the drug.
 
The FDA’s decision is based on reports of sexual side effects from men taking the drugs. In some cases, the side effects lasted for at least three months after the drug was stopped.
 
The FDA stated, “Despite the fact that clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, these cases suggest a broader range of adverse effects than previously reported in patients taking these drugs. Information about these adverse events may be important to individual patients. Therefore, prescribers and patients need to be aware of them, as part of a discussion on risk and benefits of finasteride when determining the best treatment options.” (emphasis by the FDA)
 
The number of men experiencing sexual side effects has been small. For example, in a controlled clinical trial, 3.8% of men taking Propecia reported sexual adverse events compared to 2.1% of the men who took a placebo.
 
Both Propecia and Proscar are manufactured and sold by Merck. According to Medical News Today, Merck spokesperson Pamela Eisele said, “Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Merck believes that Propecia and Proscar are generally well tolerated and effective for their respective indicated use when used in accordance with their approved labeling."
 
In 2011, the labels of both Propecia and Proscar were revised to include erectile dysfunction that continued after stopping the drug. 
 
Adverse events related to Propecia or Proscar may be reported to the FDA MedWatch program at (800) 332-1088. The SMSNA position statement on this topic may be found at the following link: http://www.sexhealthmatters.org/page/position-statement-on-5-alpha-reductase-inhibitors

Resources

ABC News
Gann, Carrie
“Propecia: FDA Warns on Baldness Drug”
(April 16, 2012)
http://abcnews.go.com/blogs/health/2012/04/16/propecia-fda-warns-on-baldness-drug/

Medical News Today
Nordqvist, Christian
“Propecia and Proscar to Have Sexual Problems Warning Label”
(April 13, 2012)
http://www.medicalnewstoday.com/articles/244109.php

Merck
“Important Risk Information about Propecia”
http://www.propecia.com/finasteride/propecia/consumer/propecia_safety.jsp?WT.svl=2

U.S. Food and Drug Administration
“Questions and Answers: Finasteride Label Changes”
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Photo
"
Propecia Bottle closeup"
CC-BY via Wikimedia Commons
ryan from Portland, US