Propecia: Man Wanted Hair, but Got the Side Effects, Lawsuit Says

http://www.drugs.com/news/man-wanted-hair-but-got-lawsuit-says-31396.html

From Ledger (Lakeland, FL) (May 16, 2011)

May 15–BARTOW – Eddie Sebastia was aiming to improve his appearance, not interfere with his sex life, when he took Propecia or Proscar from 1998 to 2007.

The drugs, which contain finasteride, were prescribed for male pattern hair loss, the Polk County man said in a lawsuit filed in circuit court. Instead, he contends, it led to erectile dysfunction, decreased libido, testicular pain and related emotional issues, including depression and anxiety.

Male pattern hair loss is a common condition in which men have gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head, according to the National Institutes of Health.

Sebastia and his wife, Lisa, are suing Merck & Co. Inc., a global pharmaceutical company, and Merck, Sharp & Dohme Corp., a subsidiary that distributes both drugs.

Similar lawsuits have been filed by other men nationwide, with some law firms advertising their interest in class-action lawsuits. Some online websites warn of possible long-lasting or permanent side effects.

A Merck spokesman, however, responding to other lawsuits about Propecia, is quoted in the Philadelphia Inquirer as saying Merck is prepared to “vigorously defend” against them.

Propecia is marketed for male pattern hair loss. It’s a lower dose of finasteride than Proscar, which Merck markets for treating prostate gland enlargement.

Sebastia said his doctor told him, when he took Proscar, to divide the Proscar tablet containing 5 mg of finasteride into separate daily doses. The other drug, Propecia, has 1 mg of finasteride.

Propecia blocks the body’s production of a male hormone in the scalp that stops hair growth.

Merck failed to adequately warn Sebastia or his prescribing physician that he could develop permanent and lasting sexual dysfunction, the lawsuit charges. It claims the company left that warning out of its consumer marketing and its information to doctors.

Merck’s www.propecia.com website now gives this warning on the first screen visible on the site:

“In clinical studies for Propecia, 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. Each of these side effects occurred in less than 2 percent of men and went away in men who stopped taking Propecia because of them.”

It also said Propecia was developed to treat mild to moderate male pattern hair loss on the top of the head and on middle front of head, emphasizing that it’s for men only.

Sebastia’s lawsuit said the warning was under the tab “Possible Side Effects,” which also has a version of that warning.

“The statements by Merck regarding Propecia are deceptive and misleading in that they fail to advise potential uses of Propecia that numerous users of the product have reported suffering persistent and permanent side effects even after discontinuing use,” the lawsuit said.

Sebastia said he sustained permanent injury and impairment and continues getting ongoing treatment. His wife is a party in the suit due to alleged loss of consortium.

He and his wife are represented by Jeffrey Bell of Bell & Melamed in Fort Lauderdale.

Hey didnt you use Propecia for over a decade as well

» Merck’s www.propecia.com website now gives this warning on the first screen
» visible on the site:
»
» “In clinical studies for Propecia, 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.
» Each of these side effects occurred in less than 2 percent of men and went
» away in men who stopped taking Propecia because of them.”

Why they warn “now” - after more than a decade?

Interesting FDA to Merck letter (1998 !!):

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168159.pdf

» » Merck’s www.propecia.com website now gives this
» warning on the first screen
» » visible on the site:
» »
» » “In clinical studies for Propecia, 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.
» » Each of these side effects occurred in less than 2 percent of men and
» went
» » away in men who stopped taking Propecia because of them.”
»
» Why they warn “now” - after more than a decade?
»
» Interesting FDA to Merck letter (1998 !!):
»
» http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168159.pdf

That’s interesting, I’m from this area too.

» » » Merck’s www.propecia.com website now gives this
» » warning on the first screen
» » » visible on the site:
» » »
» » » “In clinical studies for Propecia, 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.
» » » Each of these side effects occurred in less than 2 percent of men and
» » went
» » » away in men who stopped taking Propecia because of them.”
» »
» » Why they warn “now” - after more than a decade?
» »
» » Interesting FDA to Merck letter (1998 !!):
» »
» »
» http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168159.pdf
»
» That’s interesting, I’m from this area too.

http://onlinelibrary.wiley.com/doi/10.1111/j.1743-6109.2010.02157.x/abstract

should check this out

» Why they warn “now” - after more than a decade?
»
» Interesting FDA to Merck letter (1998 !!):
»
» http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168159.pdf

More “good news” on Propecia …

June 9, 2011
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer

http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm

Thank god i quit it while i was ahead. Man i hope that people now reevaluate their “heavy” usage of Propecia.

And that guys is the perfect example why " We highly recommend our transplant patients to use Propecia and get a FUT" is just plain disgusting

And as you can see after a few decades, i was right we will get numerous cancer patients and also impotent guys en masse and yes they will have a full head of hair after Gho and co but get cancer…this is a bad bargain

PS : IronMan do you still use Propecia

» FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer | FDA

  1. The trials demonstrated an overall reduction in prostate cancer diagnoses with finasteride 5 mg and dutasteride treatment (see Data Summary below). This overall reduction was due to a decreased incidence of lower risk forms of prostate cancer

  2. However, both trials showed an increased incidence of high-grade prostate cancer with finasteride and dutasteride treatment

Even if you die from 2), then you aren’t going to die form 1). Oh, wait …

Conclusion : Biology is very complex, we are fuced up, life scks sometimes, no pain no gain, trials are useless, etc … Seriously, we humans don’t know how to design drugs to cure any disease, we don’t know the domain of the problem, and trial and error is very slow and very limited. Hopes ? a) maybe machines will be able to do what we can’t do if some kind of AI emerges in the next decades ? Maybe, or maybe not. b) BCI enthusiasts say that in 20/25 years we will upload ourselves to the cloud, and we will just transcend our biological nature. Not strong AI needed, just advanced Brain Computer Interface, which already exists today as a preliminary crude version. Doesn’t it sound crazy ?

A very recent link from a few days ago :

http://www.ishrs.org/articles/finasteride-announcement.htm

International Society of Hair Restoration Surgery Task Force on Finasteride Adverse Event Controversies

April 29, 2011

Since 1998, finasteride (Propecia®) has successfully helped millions of men with androgenetic alopecia with a relatively low side effect profile. Recently, several reports in the media and health-related literature have described a number of younger men with androgenetic alopecia who claim to have experienced persistent sexual side effects following the use and subsequent discontinuation of finasteride. The International Society of Hair Restoration Surgery (ISHRS) has established the Task Force on Finasteride Adverse Event Controversies to evaluate published data and to inform and update our ISHRS members regarding the use of this medication.

To date, there is no evidence-based data substantiating the link between finasteride and persistent sexual side effects in the numerous double blinded, placebo controlled studies using finasteride 1mg for hair loss. Reports of persistent sexual side effects have come from a variety of sources, with some internet sites attracting individuals claiming to have sexual and psychological issues related to finasteride. While continued difficulty having erections after discontinuing finasteride has been reported in post-marketing surveillance the incidence of this problem remains unknown. This rare side effect is included in Merck’s patient product information in the United States, and in Public Assessment Reports of the Medicines and Health Regulatory Agency of the United Kingdom and the Medical Products Agency of Sweden.

The persistence of sexual side effects appears to be a rare event, and it has yet to be determined whether these recent reports represent a true causal relationship, or if they are simply coincidental and related to other factors such as the high incidence of sexual dysfunction in the general population, and/or the placebo effect. Also, little data is available concerning the medical and psychological workup of these patients to exclude other potential causative factors.

At the present time, the mechanism of interaction between the brain, 5 alpha-reductase metabolism, and hormones on sexual dysfunction is speculative and poorly understood. Clearly, this is a complicated issue, which overlaps with other disciplines in medicine such as Endocrinology, Urology, and Psychiatry. More research is needed to assess the actual incidence of side effects, to determine if there is a true causal relationship for persistent side effects, and, if so, to identify who may be at risk. We hope to participate in a multidisciplinary forum to further evaluate this topic.

Millions of patients have benefitted from finasteride with no side effects at all, or minimal and reversible side effects. It is important for the medical community to verify anecdotal reports, and, if necessary, conduct further studies so that accurate information may be given to our patients to enable them to make informed choices regarding the use of this medication.

The ISHRS Task Force on Finasteride Adverse Event Controversies is in the process of gathering information and forming an interdisciplinary panel to address these issues and to keep our ISHRS members informed regarding post- marketing adverse events.

Apart from this, that the text above already mirrors their final result without doing anything, I simply don’t trust any “ISHRS members” in general, and as long as they are (main)sponsored by MERCK,
I don’t trust them at all …

» BCI enthusiasts say that in 20/25 years we will upload ourselves to the cloud,
» and we will just transcend our biological nature. Not strong AI needed,
» just advanced Brain Computer Interface, which already exists today as a
» preliminary crude version. Doesn’t it sound crazy ?
»
» A very recent link from a few days ago :
»
» 'Brain cap' technology turns thought into motion; Mind-machine interface could lead to new life-changing technologies for millions of people | ScienceDaily

Yes, well, "BCI enthusiasts are full of s**t, a Brain Computer Interface is all very well but it leaves the brain effectively as a ‘Black Box’ to us - i.e. we STILL have a very limited understanding of how it works. These guys overstate the case by miles, they are still basically NOWHERE.

It is scary sh…t i am stoping soon, i am just so scared of the massive shedding after i go cold turkey!! so i am doing it slowly!

» http://www.drugs.com/news/man-wanted-hair-but-got-lawsuit-says-31396.html
»
» From Ledger (Lakeland, FL) (May 16, 2011)
»
» May 15–BARTOW – Eddie Sebastia was aiming to improve his appearance, not
» interfere with his sex life, when he took Propecia or Proscar from 1998
» to 2007
.
»
» The drugs, which contain finasteride, were prescribed for male pattern hair
» loss, the Polk County man said in a lawsuit filed in circuit court.
» Instead, he contends, it led to erectile dysfunction, decreased libido,
» testicular pain and related emotional issues, including depression and
» anxiety.
»
» Male pattern hair loss is a common condition in which men have gradual
» thinning of the hair on the scalp, leading to a receding hairline or
» balding on the top of the head, according to the National Institutes of
» Health.
»
» Sebastia and his wife, Lisa, are suing Merck & Co. Inc., a global
» pharmaceutical company, and Merck, Sharp & Dohme Corp., a subsidiary that
» distributes both drugs.

»
» Similar lawsuits have been filed by other men nationwide, with some law
» firms advertising their interest in class-action lawsuits. Some online
» websites warn of possible long-lasting or permanent side effects.

»
» A Merck spokesman, however, responding to other lawsuits about Propecia, is
» quoted in the Philadelphia Inquirer as saying Merck is prepared to
» “vigorously defend” against them.
»
» Propecia is marketed for male pattern hair loss. It’s a lower dose of
» finasteride than Proscar, which Merck markets for treating prostate gland
» enlargement.
»
» Sebastia said his doctor told him, when he took Proscar, to divide the
» Proscar tablet containing 5 mg of finasteride into separate daily doses.
» The other drug, Propecia, has 1 mg of finasteride.
»
» Propecia blocks the body’s production of a male hormone in the scalp that
» stops hair growth.
»
» Merck failed to adequately warn Sebastia or his prescribing physician that
» he could develop permanent and lasting sexual dysfunction, the lawsuit
» charges. It claims the company left that warning out of its consumer
» marketing and its information to doctors.

»
» Merck’s www.propecia.com website now gives this warning on the first screen
» visible on the site:
»
» “In clinical studies for Propecia, 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.
» Each of these side effects occurred in less than 2 percent of men and went
» away in men who stopped taking Propecia because of them.”
»
» It also said Propecia was developed to treat mild to moderate male pattern
» hair loss on the top of the head and on middle front of head, emphasizing
» that it’s for men only.
»
» Sebastia’s lawsuit said the warning was under the tab “Possible Side
» Effects,” which also has a version of that warning.
»
» “The statements by Merck regarding Propecia are deceptive and misleading
» in that they fail to advise potential uses of Propecia that numerous users
» of the product have reported suffering persistent and permanent side
» effects even after discontinuing use,” the lawsuit said.

»
» Sebastia said he sustained permanent injury and impairment and continues
» getting ongoing treatment. His wife is a party in the suit due to alleged
» loss of consortium.
»
» He and his wife are represented by Jeffrey Bell of Bell & Melamed in Fort
» Lauderdale.

Yes, I agree with you… there is some side effect… but it is best medicine for hair loss treatment.