Pharmaceutical giant, Merck & Co. introduced Propecia as a new use for finasteride, a synthetic compound the company developed five years earlier. Once originally marketed as Proscar, doctors first prescribed 5 mg of finasteride to treat benign prostatic hyperplasia (BPH), more commonly known as an enlarged prostate gland. However, one of the remarkable side effects of the Proscar treatment was the ability for some of the patients to start growing hair.
This prompted researchers to find a way to capitalize on this notion. By dropping the dose of finasteride to 1 mg, these researchers found a way to correct male pattern baldness, a hereditary condition that affects close to 50 percent of the male population 50 years or older. Backed by massive amount of money, Merck introduced Propecia to the market which garnered 400,000 men in the first year alone.
Upon the approval of the drug, Merck disclosed that 3.8 percent of Propecia patients had one or more adverse sexual experiences, compared with 2.1 percent of patients taking a placebo. However, what it failed to mention was that these problems can persist even after patients stop taking the drug. In fact, Merck originally claimed that all of these issues would resolve after discontinuation of the drug .
How does it work?
In people genetically predisposed to male pattern baldness, DHT (dihydrotestosterone) binds to receptors in hair follicles at the top of the scalp. When the DHT hormone acts on these follicles, they shrink and gradually lose the ability to grow thick and healthy hair. As a result, the person’s hairline things and recedes. Hair follicles on the back and side of the head are genetically resistant to DHT, which explains the common pattern seen in male baldness. Almost 35 million men in the United States suffer from this type of hair loss. Propecia and Proscar belong to a class of drugs called 5-alpha-reductase inhibitors which causes a rapid decline in DHT concentration to combat male pattern baldness .
While there is no causal links between Propecia use and sexual side effects, the drugs method of actions makes the connection highly plausible. This is all due to the fact that finasteride, the active ingredient in Propecia, suppresses the body’s level of DHT, an androgen hormone that plays a major role in sexuality and sexual development .
The most commonly reported reactions to Propecia’s side effects affect men’s sexual health. These commonalities include decreased libido, erectile dysfunction and ejaculation disorder. A U.S. FDA analysis of adverse event data revealed a wide range of sexual side effects in otherwise healthy Propecia users ages 21 to 46. These problems persisted for an average of 40 months after the men ceased treatment. For some men, they never stopped.
In 2011, the FDA added that some adverse events such as erectile dysfunction, may continue after the drug is no longer being used. Another addition added on April 11, 2012 explained that some patients continued to experience sexual side effects after termination of use. And while there is no clear causal relationship between these adverse effects and the use of these drugs, the FDA has reviewed reports to its Adverse Events Reporting System between 1998 and 2011, noting it had received 421 reports of sexual dysfunction among patients using Propecia .
Adding to these adverse reports, there was also a study performed by Dr. Michael Irwig that was published in the Journal of Sexual Medicine. The conclusion of this study assessed that most men developed persistent sexual side effects despite the discontinuation of finasteride and that the sexual dysfunction continued for many months or years. Although several rat studies have shown detrimental changes to erectile function caused by 5 alpha reductase inhibitors, the persistent nature of these changes is an area of active research. Prescribers of finasteride and men contemplating its use should be made aware of the potential adverse medication effects .
As the FDA updated the warning in April 2012, in that same year and month, a deferral judicial panel transferred Propecia lawsuits pending in federal courts to the U.S. District Court for the Eastern District of New York. Each of these lawsuits was filed against Merck and alleged that Propecia caused “persistent sexual dysfunction.” To date, over 1,100 men across the country have filed Propecia side effect lawsuits against Merck seeking compensation for these complications.
In fact, as far back as 2006, regulators in Sweden had started investigating claims of sexual dysfunction from the drug. In 2008, Merck added warning to Swedish labels about persistent erectile dysfunction after discontinuing use. That never translated over to the United States until years later.
Plaintiffs allege Merck of failing to warn them of the serious and sometimes permanent side effects of finasteride, including erectile dysfunction, loss of sex drive and other libido disorders. Some of these men say their lives were forever altered by these side effects and that their marriages and relationships suffered as a result. These men are seeking additional compensation for loss of consortium, which is enjoyment with your partner .
Sibley Dolman Gipe Accident Injury Lawyers, PA
Taking on a giant pharmaceutical company in court can be intimidating for injured victims. However, this type of case becomes much easier to face if you have the assistance of a highly skilled and experienced defective drugs lawyer. At the Sibley Dolman Gipe Accident Injury Lawyers, PA in Clearwater, Florida, we have the knowledge and resources to face off against large companies and protect the rights of injured individuals who took defective medication. Please do not hesitate to call for a free consultation at (833) 606-DRUG  today.
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