Propecia Wrongful Death Lawsuit filed
Propecia Wrongful Death Lawsuit Filed
A Propecia wrongful death lawsuit has been filed against Merck in California federal court, claiming failure to warn of the dangerous Propecia side effects such as suicidality and suicide ideation. Although many lawsuits have been filed against Merck for Propecia dysfunction, the drug company said this lawsuit is the first of its kind to be filed.
By Martha Rosenberg.
No one should have to choose between their hairline and their health. But increasingly, men who use finasteride, commonly known as Propecia, to treat their male pattern baldness are making that choice, often unwittingly. In the 17 years since Propecia was approved to treat hair loss from male pattern baldness, so many disturbing urogenital and other side effects have emerged, the term Post Finasteride Syndrome (PFS) has been coined and hundreds of lawsuits have been brought.
Finasteride inhibits a steroid responsible for converting testosterone into dihydrotestosterone (DHT) the hormone that tells hair follicles on the scalp to stop producing hair. Years before Propecia was approved to grow hair, finasteride was used in drugs like Proscar, Avodart and Jalyn to treat an enlarged prostate gland (benign prostatic hyperplasia). Like Viagra, which began as a blood pressure med, or the eyelash growing drug Latisse, which began as a glaucoma drug, finasteride's hair restoration abilities were a fortuitous side effect.
Sexual side effects
Since Propecia was approved for sale in 1997, its label has warned about sexual side effects. ''A small number of men experienced certain sexual side effects, such as less desire for sex, difficulty in achieving an erection, or a decrease in the amount of semen," it read. "Each of these side effects occurred in less than 2% of men and went away in men who stopped taking Propecia because of them." (The label also warned about gynecomastia, the enlargement of male breast tissue.)
But increasingly, users and some doctors are saying the symptoms sometimes do not "go away'' when men stopped taking Propecia and that their lives can be changed permanently. They report:
- Lack of sexual desire
- Depression and suicidal thoughts
- Even a reduction in the size of penises or testicles after using the drug which do not go away after discontinuation
According to Dr. Andrew Rynne, former head of the Irish Family Planning Association and a well-known surgeon, Merck -- which makes Propecia and Proscar -- knows that the disturbing symptoms do not always go away. "They know it is not true because and hundreds of other doctors and thousands of patients have told them that these side effects do not always go away when you stop taking Propecia. We continue to be ignored of course."
In some cases, says Dr. Rynne, men who have used the finasteride for even a few months "have unwittingly condemned themselves to a lifetime of Sexual Anhedonia," [a condition in which an individual cannot feel pleasure from orgasm], the most horrible and cruel of all sexual dysfunctions."
"I have spoken to several young men in my clinic in Kildare who continue to suffer from sexual anhedonia and for whom all sexual pleasure and feelings have been obliterated for all time. I have felt their suffering and shared their devastation," he says on a Propecia help site.
Lost their marriages, jobs
Sarah Temori, who launched a petition on Change.org to have finasteride taken off the market, agrees. "Many who have taken Propecia have lost their marriages, jobs and some have committed suicide due to the damage this drug has done to their bodies," she writes. "One of my loved ones is a victim of this drug. It's painful to see how much he has to struggle just to make it through each day and do all the daily things that we take for granted. No doctors have been able to help him and he is struggling to pay for medical bills. He is only 23."
Stories about Propecia's disturbing and underreported side effects have run on CNN, ABC, CBS, NBC, and Fox and on Italian and English TV news. Medical literature has also featured investigations into finasteride effects.
A study last year in the Journal of Sexual Medicine noted "changes related to the urogenital system in terms of semen quality and decreased ejaculate volume, reduction in penis size, penile curvature or reduced sensation, fewer spontaneous erections, decreased testicular size, testicular pain and prostatitis."
Many subjects also noted a "disconnection between the mental and physical aspects of sexual function," and changes to mental abilities, sleeping patterns, and/or depressive symptoms.
A study this year in the journal of Steroid Biochemistry and Molecular Biology finds that "altered levels of neuroactive steroids, associated with depression symptoms, are present in androgenic alopecia patients even after discontinuation of the finasteride treatment."
Approved in haste, regretted later
The rise and fall of Propecia parallels other drugs like Vioxx or hormone replacement therapy that were marketed to wide demographics even as safety questions nipped at their heels. Because two thirds of American men have some hair loss by age 35, and by age 50, 85 percent of men do, Propecia had the promise of a blockbuster like Lipitor or Viagra.
Early ads likened men's thinning scalps to crop circles. Later, award-winning ads likened saving scalp hair to saving the whales. Many Propecia ads tried to take away the stigma of hair loss and its treatment. "You'd be surprised who's treated their hair loss" said one print ad depicting athletic looking, twentysomething men. In 1999 alone, Merck spent $100 million marketing Propecia directly to consumers, when direct-to-consumer advertising was just beginning on TY.
Nor was Propecia only sold in the U.S. Overseas ads compared twins who did and did not use the product. In the U.K., the drug store chain Boots aggressively marketed Propecia at its 300 stores and still does. One estimate says Propecia was marketed in 120 countries -- half the world.
Many have heard of "indication creep" when a drug, after its original FDA approval, goes on to be approved for myriad other uses. Seroquel, originally approved for schizophrenia, is now approved as an addon drug for depression and even for use in children.
Cymbalta, originally approval as an antidepressant, went on to be approved for chronic musculoskeletal pain. Less publicized is "warning creep" -- when a drug that seemed safe enough for the FDA to approve collects warning after warning once the public is using it.
Lessons from Fosamax
The prime example of "warning creep" is the bone drug Fosamax. After it was approved and in wide use, warnings began to surface about heart problems, intractable pain, jawbone death, esophageal cancer and even the bone fractures it was supposed to prevent.
But finasteride may be worse than Fosamax.
- In 2003, it gained a warning for patients to promptly report any "changes in their breasts, such as lumps, pain or nipple discharge, to their physician." Soon, "male breast cancer" was added under "Postmarketing Experience."
- In 2010 depression was added as a side effect and patients were warned that finasteride could have an effect on prostate specific antigen (PSA) tests.
- In 2011, the label conceded that sexual dysfunction could continue "after stopping the medication" and that finasteride could pose a "risk of high-grade prostate cancer." In 2012, a warning was added that "other urological conditions" should be considered before taking finasteride. In 2013, the side effect of angioedema was added.
Nor does a quick look at Propecia approval documents inspire confidence. Finasteride induces such harm in the fetuses of lab animals, it is contraindicated in women when they are or may potentially be pregnant and women should not even "handle crushed or broken Propecia tablets when they are pregnant." Clinical trials were of short duration and some only had 15 participants. While subjects were asked aesthetic questions about their hairline during and after clinical trials, conspicuously absent on the data set were questions about depression, mental health and notably, shrinking sexual organs.
In one report, an FDA reviewer notes that Merck did not name or include other drugs used by subjects during trials, such as antidepressants or Gerd meds, suggesting that depression could have been a known side effect of Propecia. Elsewhere an FDA reviewer cautions that "low figures" in the safety update are not necessarily reliable because the time period was "relatively short" and subjects with sexual adverse events may have already "exited from the study." An FDA reviewer also wrote that "long term cancer effects are unknown." Breast cancer was noted as an adverse event seen in the trials.
Propecia users speak out
There are many Propecia horror stories on sites founded to help people with side effects and those involved in litigation. In 2011, a mother told CBS News she blamed her 22-year-old son's suicide on Propecia and Men’s journal ran a report called "The (Not So Hard) Truth about Hair Loss Drugs."
In a database of more than 13,000 finasteride adverse effects reported to the FDA, there were 619 reports of depression and 580 reports of anxiety. Sixty-eight users of finasteride reported a "penis disorder" and small numbers reported "penis deviation," "penis fracture" and "micropenis." On the patient drug review site Askapatient.com, the 435 reviews of Propecia cite many examples of depression, sexual dysfunction and shrunken penises.
One of the most visible faces for Post Finasteride Syndrome is 36-year-old UK resident Paul Innes. Previously healthy and a soccer player, Innes was so debilitated by his use of Propecia, prescribed by his doctor, he has founded a web site and gone public. Appearing on the show This Morning recently, Innes described how using Propecia for only three months on one occasion and three weeks on another produced a suicidal depression requiring hospitalization, sexual dysfunction and a reduction on the size of his reproductive anatomy -- none of which went away when he ceased the drug.
He and his former girlfriend seated next to him, Hayley Waudby, describe how the physical and emotional changes cost them their relationship itself, even though she is pregnant with his child. The TV segment is ironically sponsored by Boots, the UK drug chain which aggressively advertises its Propecia-based hair loss clinics and through which Innes ordered his Propecia the second time.