Posts Tagged ‘ ISHRS ’

Hair Restoration Society Issues Statement on Propecia Sexual Dysfunction

December 16th, 2011. By AbiK

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.

Propecia Erectile Dysfunction AERS Reports

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…“).

Propecia, Sexual Dysfunction and the Middle-Aged Man?

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.

Anecdotal Propecia AERS Reports Lead to Task Force

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.

Tags: Finasteride, International Society of Hair Restoration Surgery, ISHRS, Propecia, Propecia Lawsuit, Propecia Sexual Dysfunction, Proscar
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | 2 Comments »