We were waiting for this one. The International Society of Hair Restoration Surgery (ISHRS)—yes, there is such an organization—issued a press release earlier this week to state its position on the claims of Propecia sexual dysfunction that have been swirling around.
The ISHRS aims to quell concerns over reported Propecia side effects—namely those regarding sexual dysfunction, loss of sexual interest, and claims of infertility—by stating that there have been “no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.”
Additionally, the ISHRS states that anecdotal reports of adverse events (as in erectile dysfunction) “should not define the safety and effectiveness of this drug”. Such a statement is reminiscent of that line about a disease being “rare” until you’re the one affected by it. True, some random report from a guy on Propecia having sexual difficulties is not perhaps indicative of a large-scale problem or cause for alarm. Unfortunately, though, the anecdotal reports are more than just a few one-off’s, and they are a cause of concern for the men who report them.
According to drugcite.com–a website that aggregates data from the FDA Adverse Event Reporting System (AERS), there have been 363 adverse events reported to the FDA for Finasteride (Propecia and Proscar). Of note, the most common reported Finasteride adverse event is erectile dysfunction.
The numbers seem low at first glance, but hair loss and sexual dysfunction don’t tend to be topics that anyone really wants to “come out” about and certainly not call attention to. And that raises the question of underreporting—could it be that due to the nature of the side effects not too many men really want to come forward and first, admit there is a problem to themselves, and then take it a step further and officially report it?
Given the upward trend of AERS reports from 2009 to 2011, one can only surmise that as more information regarding Propecia sexual side effects has hit the mainstream media—for example, the recent story in Men’s Health magazine—perhaps the stigma of talking about it has been reduced a bit (“see honey, it’s not me—it’s that hair loss drug I’ve been on…“).
Of note, the ISHRS release mentions that sexual dysfunction can be hard (no pun there) to assess—after all, there are numerous factors that can contribute to such problems: “nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression”. And, according the the release which quotes a 2006 study in the Archives of Internal Medicine, incidence of erectile dysfunction in middle-aged or older men in the general population can be as high as 49%.
That make sense—except when you look at the anecdotal reports from Propecia users (some of which are on LawyersandSettlements.com) and see that the victims can be rather young—in their 20’s and 30’s, some even as young as 19. So not quite in that “middle-aged or older” group.
According to AmericanHairLoss.org, “Approximately twenty five percent of men who suffer with male pattern baldness begin the painful process before they reach the age of twenty-one.” The ISHRS itself states on its site that “Hair loss in men is likely to occur primarily between late teen-age years and age 40-50″—if so, it would appear that the statistic of E.D. occurring in potentially 49% of middle-aged or older men is somewhat irrelevant.
Perhaps the most telling aspect of the ISHRS press release is the announcement that the organization has formed a task force to review the anecdotal reports of sexual dysfunction among certain Propecia users. While it’s certainly the responsible thing to do, it also somehow validates that there is growing concern over the drug’s potential for harmful side effects.
According to the release, the ISHRS has also reached out to “dermatologists, hair loss physicians, urologists, endocrinologists and sexual medicine specialists” to be a part of the task force and share their data and experiences with finasteride in a “fact-based manner”.
Undoubtedly there will be more to come—Propecia lawsuits included.
The drug may be from the good ol’ U.S. of A., but it would seem that Propecia lawsuits—and a recent Propecia class action in Canada (or, actually a Proscar class action, as it’s known up north)—may be forging a groundswell here for Propecia litigation. Not surprising, given that the issues with Propecia center around something a red-blooded American male may not want to be publicly “first to market” with, so to speak—i.e., Propecia sexual side effects—better to let the folks across the pond start that trend.
The Propecia side effects being referred to here are lack of sexual drive…impotence. And, from the sound of it in the BBC radio clip above, they may be less rare than you’d expect. Unfortunately too, both “James” (profiled above) and the lead plaintiff in the Canadian Proscar class action are young men—men who should be in their prime sexually. Needless to say, finding themselves unable to perform on the heels of seeking out a remedy for male pattern baldness has been quite emotionally devastating.
Now, to be fair, that Propecia does work to combat male pattern baldness is not in question here—and many men have used the drug successfully. Even those who speak out against it state that it does work for the majority of patients taking it. But at what potential price? What’s at issue here is the number of men who appear to be suffering some rather serious side effects in direct correlation to taking Propecia.
And now, the big question that’s being asked not only here in the US but also on the international media scene, is to what extent are these Propecia side effects permanent? Historically, the ‘official line’ has been that if you either a) continue to just use Propecia, any such side effects will subside; or b) that if you stop taking Propecia, the side effects will go away. Hmm. Try telling that to James and Michael Miller, the young gentleman who’s filed the Canadian Proscar class action against Merck Frosst Canada…
Think about it. To step up to the plate and serve as lead plaintiff in a Propecia class action, a man’s got to bare his sole a bit. He’s got to come out of the proverbial closet on a few things. Well, two to be exact: male pattern baldness and sexual dysfunction. How many red-blooded men—in their prime mating years (i.e., their 20’s) would have the you-know-what’s to do that?
Enter Michael Miller of Vancouver. Maybe it’s the beer, cold weather, ‘BC bud’, or just the sheer sense of humor of our neighbors in the Great White North that brings a man—a young man—to lead a pack of over 80 Canadian men in charging Merck Frosst Canada with failing to adequately warn Canadians of the possible risks associated with taking Propecia. (By the way, Propecia is also known by another brand name, Proscar; both are the generic drug Finasteride.)
Miller is apparently quite open in sharing his tale of woe. Seems he was noticing some hair thinning going on (those of you who’ve been to your five or ten year high school reunion have no problem visualizing this). So Miller’s doctor put him on Proscar (Propecia). And about a month later, he experienced what’s possibly a twentysomething’s worst nightmare: he lost interest in sex.
According to the release put out by his law firm, Klein Lyons, Miller stated, “I lost my interest in sex and I felt anxious in social situations for no particular reason.” He also says that after stopping Proscar, the symptoms did not go away: “My sexual functioning has not recovered, I have seen specialists and have tried treatments but nothing has worked.”
All kdding about male prowess aside, it’s one thing to have adverse side effects from a drug and know that they are non-life-altering and circumstantial—that they’ll only be present during the Read the rest of this entry »