Two popular medications created for men may cause long-term side effects, including erectile dysfunction and infertility. Patients taking Propecia, a medication to reverse baldness and Proscar, a treatment for enlarged prostate, could be at higher risk of suffering adverse sexual reactions—especially if they take these drugs for a long period of time.
The History of Propecia and Proscar
Propecia is a prescription medication used for the treatment of androgenetic alopecia, also called male pattern hair loss. This condition occurs when hair becomes thinner on the crown of the head (also referred to as a bald spot) and may involve a receding hairline and thinning of the hair at the temples.
Androgenetic alopecia is hereditary and affects half of all men over age 50. Propecia binds the male hormone DHT to the receptors in hair follicles in the scalp, effectively keeping the hair in place.
Propecia was developed after doctors found that patients taking Proscar for benign prostatic hyperplasia (commonly called an enlarged prostate) reported that their hair started growing back.
Researchers created Propecia by increasing the main ingredient of Proscar, finasteride. Finasteride is a 5-alpha reductase inhibitor, meaning it reduces male hormone activity in the body.
Sexual Side Effects of Propecia and Proscar
Over 1,000 men have filed lawsuits claiming the drug manufacturer Merck & Co., Inc. failed to warn both doctors and consumers of the potential for long-term sexual dysfunction when using Propecia. These product liability lawsuits are supported by data from the U.S. Food and Drug Administration (FDA), which found that sexual side effects can continue for months after patients discontinue taking the drugs.
Claims against the drug maker include allegations of:
- Defective product claims. Court documents allege that Propecia is both defective and unreasonably dangerous, causing serious side effects when used as intended.
- Improper research and design. Drug makers are responsible to adequately test and manufacture products that have a relatively low risk of injury when used as prescribed. Plaintiffs have found fault in Merck's processes for Propecia and Proscar.
- Failure to disclose risks. Plaintiffs allege that Merck was aware or should have been aware of the potential for Propecia to cause persistent sexual side effects, but did not provide adequate warnings to the public.
- Improper marketing. Patients say that the company inadequately labeled the drug prior to 2011 by omitting sexual dysfunction risks, and profited off of the public’s ignorance of these risks.
According to the FDA’s Adverse Events Reporting Systems (AERS), at least 59 men suffered sexual dysfunction that continued for at least three months after they stopped using Propecia. Studies have also shown that between 2-4 percent of patients taking finasteride medications suffer adverse sexual effects, most commonly erectile dysfunction (ED).
In the medications’ updated warning labels, the FDA warns that patients taking finasteride may suffer:
- Loss of sexual desire. Low sex drive from taking Propecia or Proscar that may continue for some time after men stop using the drugs.
- Inability to ejaculate. Many men suffer ejaculation disorders from both Propecia and Proscar that last for up to three months after patients discontinue using the drugs.
- Orgasm disorders. Patients have reported an inability to reach orgasm that may not resolve for several weeks after discontinued use of the drugs.
- Infertility. Researchers have noted several reports of male infertility and poor semen quality among finished users. The FDA recorded 251 cases of poor semen quality due to Propecia and 29 cases linked to Proscar, although the agency did report these problems seemed to improve or return to normal after discontinuation of finasteride medications.
- Erectile dysfunction. The FDA examined over 100 cases of ED in men taking Proscar that didn't resolve within three weeks after drug discontinuation.
- Male breast cancer. In 2011, the FDA updated the Propecia warning label to include information about the potential for an increased risk of breast cancer in men taking the medication.
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