When Propecia was initially developed by Merck & Co. and approved by the U.S. Food and Drug Administration (FDA), it was well-known that it had sexual side effects. However, Merck and the FDA may have underestimated the severity of Propecia sexual side effects, including persistent erectile dysfunction, decreased libido, and problems with orgasms. Many men are now angry at Merck for failing to disclose these severe side effects, and are seeking justice.
Do I Have a Propecia Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured after taking Propecia, you should contact our lawyers immediately. You may be entitled to compensation by filing a Propecia lawsuit.
April 11, 2012: Today, the U.S. Food and Drug Administration (FDA) announced that the agency will be updating Propecia labels to include more warnings about the risk of persistent, severe sexual side effects that do not resolve when Propecia is discontinued. After receiving hundreds of reports from men who were injured by Propecia, the new labels will warn about the possible risk of libido disorders, orgasm disorders, and ejaculation disorders. The FDA will also warn that while men are taking Propecia, they may have fertility problems and decreased quality of semen.
Propecia (finasteride) was initially developed by the drug company Merck as a treatment for enlarged male prostate, in 5-mg doses under the brand-name Proscar. It was designed to inhibit an enzyme (5-alpha reductase) that converted testosterone to dihydrotestosterone (DHT). Roughly 50% of the male population has a genetic tendency to have hair follicles shut down when they come in contact with DHT. By inhibiting this enzyme, Propecia halts hair loss associated with male pattern baldness. The U.S. Food and Drug Administration (FDA) approved Propecia to treat male pattern baldness in 1997, and since then, millions of men have used this medication.
Merck claims low risk of Propecia sexual side effects
When Propecia was approved by the FDA, they knew that there were sexual side effects, which might include erectile dysfunction, decreased ejaculate volume, decreased libido, and more. Clinical studies had estimated the risk at around 2%. If this statistic is correct, it is likely that thousands of men have suffered sexual side effects. Merck assured these men that the problem would resolve when they stopped taking Propecia.
Unfortunately, after millions of men took this medication, many suffered sexual health problems that did not resolve when they stopped taking Propecia. Furthermore, the actual risk of Propecia sexual side effects may have been significantly higher than Merck or the FDA anticipated.
Swedish study of Propecia and Persistent Erectile Dysfunction
When a Swedish scientific study from 2008 found that men who used Propecia were more likely to suffer from persistent erectile dysfunction, the Swedish Medical Products Association required Merck to update the safety labeling. Health authorities in the United Kingdom soon followed suit, Merck was forced to update the safety labeling in several European countries.
However, the FDA did not compel Merck to make the same updates in the United States. In fact, it was not until summer of 2011 — nearly four years after the Swedish updates — that Merck decided to voluntarily update the American labeling to include the risk of persistent erectile dysfunction.
Studies of persistent Propecia sexual side effects
In 2011, two studies were published in the Journal of Sexual Medicine regarding sexual side effects of Propecia. Both studies were conducted in response to an increasing number of men who had complained that Propecia sexual side effects did not resolve when they stopped using the medication. Both studies found evidence of severe, persistent sexual health problems in men who had taken Propecia. The following two doctors conducted the studies:
- Dr. Michael Irwig, a doctor at George Washington University School of Medicine, interviewed men who were participating in an online forum for men who had suffered Propecia sexual side effects and were looking for help. Dr. Irwig found that a large number of these men were suffering from multiple sexual problems, most frequently persistent erectile dysfunction, low sexual desire, and problems reaching orgasm. Even more troubling, some of the men had suffered these problems for months, and sometimes years, after stopping Propecia.
- Dr. Abdulmaged M. Traish, of Boston University, is a professor of biochemistry and urology. He led a team that reviewed the existing medical literature for information regarding the link between Propecia and sexual side effects. What they discovered was that 8% of Propecia users reported erectile dysfunction, and 4.2% suffered from low sexual desire. These rates are approximately twice the rates seen in men who had taken a placebo.
Propecia Side Effects
As more and more men realize that their sexual dysfunction may have been caused by Propecia, many are seeking help from a Propecia lawyer and deciding to file a Propecia lawsuit. Many are also submitting their information to the FDA’s Medwatch program. The FDA has recently confirmed that it is conducting a safety review of this information. Many experts are now calling this Post-Finasteride Syndrome.
Propecia sexual side effects may include, but are not limited to:
- Sexual side effects
- Male breast cancer
- High-grade Prostate Cancer
- Erectile dysfunction (impotence)
- Loss of libido
- Decreased sensation in the penis
- Difficulty orgasming
- Decreased semen volume
- Body disfigurement
- Gynecomastia (growth of male breast tissue)
- Genital shrinkage
- Penile fibrosis
- Decreased muscle mass
- Increased female-pattern fat deposits
- Endocrine System Crash
- Emotional trauma, psychological damage
- Post-Finasteride Syndrome
Because Propecia may also cause dramatic changes to a man’s brain chemistry and hormones, this medication may also have other non-sexual side effects. The FDA has already warned that Propecia increases the risk of depression, male breast cancer, and aggressive high-grade prostate cancer. The list of non-sexual Propecia side effects includes:
- Depression, anxiety
- Prostate Cancer
- Breast Cancer
- Male breast enlargement, called “gynecomastia”
- Female-pattern body fat
- Cognitive impairment
- Memory impairment
- Muscle atrophy
- Problems sleeping
Do I have a Propecia Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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