Official: FDA has published labeling changes for Propecia (Finasteride 1mg)

Following a lengthy safety review, the FDA has mandated that Finasteride (Propecia, Proscar) must carry additional warnings regarding the possibility of persistent sexual side effects. The following text is now part of the propecia label:

"Postmarketing experience:
Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders;  male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain."

It's the first time FDA admits infertility problems and orgasm disorders related to Propecia The FDA also advises that they have started the process of notifying health care professionals who prescribe Finasteride (dermatologists, physicians, urologists and residents) on the revision and label changes.

To read the full article on the FDA website:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Propecia precribing information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf

Stories of men who took Finasteride 1mg for hair loss and developed irreversible side effects.

If you are Suffering from unresolved side effects from Propecia or Finasteride 1 mg, please post your story under this post as a comment. Choose "Anonimo" to post anonimously. Please state your age, where you are from, the sides you have, When You quit and how long you took it for. Try to summarize it in ten lines or less. Thank you!  

Forum member "worried" from Propeciahelp.com: 
http://www.propeciahelp.com/forum/viewtopic.php?t=689 
"I am currently suffering sexual dysfunction like decreased penile sensitivity, difficulty getting/mantaining erections, decreased semen volume, watery semen, loss of spontaneous erections and low libido. I'm 23 and I took Propecia for 3 years."

Merck's Drug Propecia Linked To Sexual Dysfunction

"Merck — the pharmaceutical giant previously featured on Slashdot for drawing up a 'hit list' of doctors that criticized its drug Vioxx, and creating a fake medical journal to endorse its products — is embroiled in a new scandal. USA Today is reporting on two new studies that show Propecia, Merck's $250 million prescription medication for baldness, can make men irreversibly impotent. Lawsuits have been filed in the United States and Canada from men claiming to have permanently lost their sexual function after taking the drug. All this is reminiscent of Merck's difficulties with Vioxx, a once $2.5-billion-a-year drug, which was withdrawn from the market in 2004 after a study showed it doubled the risk of heart attack and stroke in users."

Slashdot.com:
http://science.slashdot.org/story/11/04/09/0151206/Mercks-Drug-Propecia-Linked-To-Sexual-Dysfunction
USA Today:
http://yourlife.usatoday.com/health/medical/menshealth/story/2011/03/Sexual-side-effects-from-Propecia-Avodart-may-be-irreversible/44787684/1

General symptoms of Post-Finasteride Syndrome and doctors who recognize the problem.

Dr. John Crisler DO

Lansing, Michigan - USA

Explaining the symptoms of Post-Finasteride Syndrome in a conference.

Exerpt from the video:

Dr. John Crisler: - "I've talked to some of you in particular. I am totally against the drug Finasteride. I've had so many patients in my office stating that this drug has destroyed their lives. Many of these patients are from the Yahoo forum (the origin of PropeciaHelp.com). Unfortunately some suicides have occurred in this forum. For some reason some men have an endocrine system that seems ready to be "broken" by Finasteride . And they take Finasteride for periods as short as one week, and it destroys their lives, they become weak, depressed, helpless . The problem is that when they stop taking the medication, the symptoms continue. We do not know why."

Dr. Michael Irwig, Professor at George Washington University

TV station in Sweden - Possibility of permanent side effects is now official in Europe (2009). - Two videos.

Swedish Medical Products agency, the UK's Medical and Healthcare Products Regulatory Agency (MHRA) and the Italian government investigated finasteride and changed the label in their countries.

Excerpt from the page on the English Wikipedia's Finasteride http://en.wikipedia.org/wiki/Finasteride

There are case reports of persistent diminished libido or erectile dysfunction, even after stopping the drug.[18] In December 2008, the Swedish Medical Products agency concluded a safety investigation of finasteride and advised that finasteride may cause irreversible sexual dysfunction. The Agency's updated safety information lists difficulty in obtaining an erection that persists indefinitely, even after the discontinuation of finasteride, as a possible side effect of the drug.[19] The UK's Medical and Healthcare Products Regulatory Agency (MHRA) cites reports of erectile dysfunction that persists once use of finasteride has stopped.[20] Similar labeling changes have been made by the Italian government. For a period of time there was a discrepancy between European and North American warning labels regarding the risks of developing persistent sexual side effects from taking Propecia but after two years in April 2011 Merck revised the United States' warning in consumer and medical leaflets to include erectile dysfunction that may persist after stopping finasteride.[21] In April 2012, the FDA chose to approve Merck's proposed labeling from 2011 only after the warning label was further strengthened to include reports of persistent libido disorders, ejaculation disorders, orgasm disorders, and decreased libido. [22][23][24]

Fox 9 - Finasteride 1mg and the risk of permanent sexual disfunction.

Former Finasteride 1 mg user reports the medicine had an effect on his fertility

User "Furrymonkey" from the Hairlosstalk.com forum:
http://www.hairlosstalk.com/interact/showthread.php/56059-fin-propecia-the-perfect-contraceptive-infertility!?highlight=fertility

"Been taking finasterid products (pro and finpecia) for a number of yrs now, doing a relatively good job, but no wonders. No noticeable side-effects either. Btw, I'm 32 now. Started trying for kids about a year ago without success which led to me researching if finasteride has any effect on . Had my sperm count then tested about 3 months ago. Result: basically no useful sperm, i.e. very low concentration and low to no motility. The doc recommended I stop taking Finpecia (after he did some of his own research). Problem is that dermatologists and urologists have little to no common ground, which is why this problem seldomly comes to light. So after having stopped taking the hair drug for 3 months and another sperm test the results are astounding: concentration has tenfolded and motility has gone up from just about zero to 25% (normal and healthy would be around 50% mobility). I'm going for another test in 3 months again to see where my fertility is going.

Conclusion: if you're planning on having kids, take this as a warning that merck and co. don't give a rats arse if your fertility goes down, as long as libido apparently is fine, right?

Evaluation of Propecia (Finasteride) by american patients in Askapatient.com site

http://www.askapatient.com/viewrating.asp?drug=20788&name=PROPECIA


346 Patients were asked about the efficacy, safety, side effects and whether they would recommend the drug to others. Each patient is told to give a rating from 1 to 5, with note 1 (Very dissatisfied - I would not recommend anyone taking this drug) and Note 5 (Very Satisfied - this medicine has helped me and healed me).

CBS News - Risk of permanent sexual side effects in men who take Finasteride for hair loss.

How Finasteride affects your metabolism