BREAKING NEWS: New Prescription Information for Propecia released in Europe, persistent erectile dysfunction now OFFICIAL

General Discussion
#1

[Size=4]BREAKING NEWS: New Prescription Information for Propecia released in Europe - Permanent Erectile Dysfunction now official.[/size]

Hi,

[b]Apparently the special investigation of Propecia conducted by the Swedish Medical Products Agency is now completed (http://www.lakemedelsverket.se/Tpl/NewsPage____5522.aspx)

Details: viewtopic.php?t=882. [/b]

[Size=4]This has resulted in an updated Prescription Information for Propecia. The full version of the new english Presciption Information can be retrieved from here:[/size]

http://www.lakemedelsverket.se/upload/SPC_PIL/Pdf/enhumpil/Propecia%20film-coated%20tablet%20ENG.pdf

[Size=4]Among the most important changes are (in section 4, “Possible Side Effects”):[/size]

[b]"* [Size=4]Persistent difficulty having an erection after discontinuation of treatment[/size].

  • Infertility has been reported in men who took finasteride for long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted."[/b]

[Size=4]In other words, it is now official that Propecia can cause permanent erectile dysfunction that persists even after the treatment has been discontinued.[/size]

As can be seen at the bottom of the document it was approved on 2008-10-17.

Since the Swedish Medical Products Agency is the organization within Europe that is assigned to monitor the safety of Propecia, the text in the new Prescription Information is valid for all European countries.

#2

Thank you for your post. I’m curious how you came across this PDF?

It’s unfortunate the Swedish Medical Agency did not release this PDF on “official” letterhead to prove it came from them – as it stands now, it looks like a Word .doc anyone could have typed up.

Irregardless, this type of documentation is just another piece of evidence that what we are describing is not in fact, psychological.

#3

You can navigate to the Prescription Information document yourself from their web site.

  1. Go the web site of Läkemedelsverket (Medical Products Agency in english): http://www.lakemedelsverket.se
  2. Make sure you are viewing the Swedish version of the web site (and not the English version). Press the Swedish flag (to the right of “Contact us” text) to get to the Swedish version of the web site.
  3. Press “Hälso- & Sjukvård” on the left side.
  4. Press “Sök läkemedelsfakta” on the left side.
  5. Press “Humanläkemedel A-Ö” on the right side.
  6. Press the letter “P” (for Propecia).
  7. Search the web page for “Propecia film-coated tablet ENG -publicerad: 2008-10-20”, and you will find the document.
#4

And you can actually get to the Swedish version of the Presciption Information from Merck Sharp & Dohme’s (MSDs) Swedish web site too.

  1. Go to: http://www.msd.se
  2. Press “Våra läkemedel” on the top of the web page.
  3. Press the “För patienter” link to the right of Propecia.
  4. You will now be directed to the Swedish version of the new Prescription Information.

I hope this is proof enough for you.

PS. Notice that you probably will not see the same Prescription Information if you go via the MSD site in another county, since the document has not been introduced in all countries yet. DS

#5

Since I was asked how I came across the link to the new Prescription Information, I might add that I got it via direct communication with the people at the Medical Products Agency (MPA) involved in the investigation. During this communication I have also found out the following information which might be of interest:

  • Depression as a listed side effect was up for discussion during the investigation, based on for example medical reports such as http://www.ncbi.nlm.nih.gov/pubmed/17026771. Unfortunately it did not make it into the new Prescription Information for some reason. Probably MSD opposed it, but I don’t know for sure.

  • As for the text “persistent difficulty having an erection after discontinuation of treatment” in the side effects section, MSD still does not agree with it (surprise, surprise!), but has been forced to accept it.

  • During the investigation it became apparent that MSD had been very ignorant when it comes to following up the persistency of reported side effects, as well as informing the MPA (and corresponding organizations in other countries, e.g. the FDA in the US) about them. I.e. MSD just noted that a person had experienced a side effect, but did not make any effort to follow up whether it persisted after the treatment had been discontinued. My guess is that this has been an intentional strategy of MSDs behalf, since they then simply can claim that they knew nothing about the side effects persisting after the treatment had been discontinued. Note that this is the same company that was responsible for the Vioxx scandal, so their track record is not the best, and they have been known to cover up serious health risks before.

  • Since MSDs side effect monitoring of Propecia as well as reporting of this to the MPA has been flawed (especially when it comes to the persistency of side effects, as stated above), the MPA has demanded that MSD should improve the safety monitoring and should provide periodical reports to the MPA.

As for my own background, I am a long time sufferer of persistent side effects resulting from a short term Propecia usage several years ago. In other words, my story is like many of yours here. My intention with this post is mainly to inform the public about the serious persistent side effects that can result from Propecia usage, so that other persons can make more wise decisions than I did when they consider starting Propecia treatment.

#6

John, thanks very much for bringing this information to the forum.

It’s pretty huge news, isn’t it? Now instead of trying to persuade doctors that finasteride can cause long-term problems, it’s written in black and white in the notes.

At least one of our major symptoms - ED - is now officially recognised, and it will surely be easier to get doctors to take this post-Fin symptom seriously.

And it surely paves the way for some kind of legal action? This long-term side was not listed when we started taking Propecia. And it sounds as though the Swedish agency thought Merck were negligent in terms of their safety procedures.

What does everyone think?

#7

Meant to add: should we contact the scientists at the Swedish agency to talk to them about possible work on the post-Fin syndrome? Are they interested in trying to figure out what is going on? Do they know of researchers who may be interested?

Mew, what are your thoughts on that?

We now have an internationally recognised body recognising that Fin can cause long-term problems. If we can work with them in any way, that seems a big step forward.

#8

I didn 't post but the researcher (a my father’s friend) living in swizz is trying to research the cause by studying fina’s study …he s doing this with others docs over there cause somebody knows about this drama.

he just wrote me 1 week ago saying he ll come to italy and i ll speak to him…my father says he s a genius and he had cured his wife cause had some strange problems etc… than he also said that if he find something by some chimichal proof,we all could go to lawsuit against merck and that’s enough like proof…so i hope he ll contact me again after his study .

anyway all u have to try ppl like this interested at our problems…mine is a family friend so he s doing this just for me cause he knows my daddy wery well…i just can hope for now.

#9

I’d say that’s a good idea, however as John_123 has already been in direct contact with them, perhaps he would be best to lead such a cause. John, what are your thoughts?

#10

The Swedish MPA is just like the FDA in the US. I.e. they mainly approve drugs for sale, monitor their safety, and decide what the prescription information for those drugs should be. They do this based on e.g. side effect reports, efficiency reports, medical reports and drug trials. See their English “About” web page for details: http://www.lakemedelsverket.se/Tpl/NormalPage____438.aspx

I don’t know what contact they have with the researchers working in the related fields of medicine, who also may be interested in investigating what causes the persistent side effects and what (if anything) can be done to combat them. But I guess since they are the organization within Europe responsible for monitoring the safety of Propecia, they ought to have some contact with them. So I definitely think it’s worth asking the MPA about this. After all I guess it’s a quite common questions they get from persons who have experienced serious side effects from medical drugs. One might also ask what responsibility MSD has when it comes to investigating this further, or even better having MSD to sponsor some non-partial organization to do the research (since I don’t trust that MSD would do a non-biased investigation of this).

Also, we should make sure to point out the fact that we (on this discussion forum) have lots of persons who have experienced persistent side effects from Propecia who also are willing to take part in any possible investigation / research trials, which gives any researcher who is interested in investigating this lots of “material” to work with so to speak. That will probably make it easier to get any researcher to “jump on the wagon”, since they know they will have a greater chance of getting some serious results out of the investigation.

I wouldn’t mind if someone else contacted the MPA about this though. I would suggest that you decide on one person who contacts them though, since I get the impression that they are pretty overloaded with work.

#11

Thanks for the reply John.

Should we take it that you would rather not be the person who contacts the agency? If you have made a good contact there, then they might listen to you more than they would a stranger. But if not, no problem: I’d be happy to get in touch. Do you know of a particular person or department we should contact?

I agree with you; I think the points we’d want to cover are:

Are you aware of anyone currently interested in or researching persistent finasteride side-effects? Would you be happy to make approaches to them in combination with us?

Given your new ruling on Propecia, are you aware of anyone who would now like to start to investigate? Would you be happy to make approaches to them on our behalf?

Does Merck have any responsibility to facilitate or fund research on this matter? Can you play any role in causing Merck to do this?

What are our legal rights in relation to Merck, given that this side-effect was not listed when we took the medicine?

And we’d certainly make clear that we have a large pool of potential case studies here.

While you are here, can I also ask about your experience with Propecia? When you took it, what side effects you experienced, if you have seen any improvement, and if you have taken any treatments/seen any doctors that helped? Again, if you’d rather not answer then of course no problem.

Thanks again for bringing this to the boards.

#12

Well, the last time I was in contact with the MPA I was informed that they have recently switched persons responsible for the safety monitoring of Propecia at the MPA. So since there now are new persons working on this, I don’t think it will be a problem if you contact them instead regarding the new questions that have popped up in this discussion thread. As a matter of fact I think it would be good if someone else opened up a new communication channel with them, and you seem like a sensible person so please go ahead.

As for which person to contact, since they recently have switched persons working on this, I would suggest that you call them (for contact information see http://www.lakemedelsverket.se/Tpl/MailPage____1114.aspx) and ask who is responsible for the safety monitoring of Propecia, and who can answer questions about their Propecia investigation (refer to http://www.lakemedelsverket.se/Tpl/NewsPage____5522.aspx). That’s what I did when I contacted them for the first time. They should be able to provide you with an email address (in the format “firstname.lastname@mpa.se”, make sure to get the spelling right!). I would definitely suggest that you contact the person you are referred to by e-mail, since then both you and the person you contact have a record of what has been discussed (it’s easy to forget if you talk over the phone).

Finally regarding my own situation, I have experienced the same persistent side effects as many others here, and my situation has not improved even though it was several years since I quit using Propecia. So basically, my situation is not unique in any way, and I unfortunately don’t have any successful treatment to recommend either. However, hopefully now that it has been made official that Propecia can cause persistent side effects, it might be easier to get the attention of the medical community so that it can be researched in order to find out what causes this to occur and what can be done to treat it.

So, I wish you good luck in contacting the MPA, and please don’t forget to report back to this discussion forum with the response you get from the them. If you have any further questions, please let me know.

#13

ScaredMale30: Hi, I know it’s holiday season, but I just want to check if you have contacted the MPA, or otherwise if/when you plan to do so? Thanks.

#14

Hi John

No problem. I haven’t yet, but I’ll try and get around to it this week or next. If it’s next week it will be Thurs or Fri, when I’m not at work.

I’ll post here as soon as I’ve made contact, and again when I get any reply.

Thanks.

#15

ScaredMale30: Since I haven’t heard from you in a while, I just want to check so that you haven’t run into any problems when trying to contact the MPA? Please let me know if you for example need more info from me in order to proceed?

#16

Hi John

Really sorry but I didn’t get around to contacting them yet. As part of my recovery I’m trying to spend less time at this site, and less time thinking about the problem.

To that end, can I pass this task to back to you? I know that you don’t want to contact the MPA yourself, but I’m sure plenty of guys here will be willing to do it.

Many apologies for the delay I’ve caused, and I hope you understand.

#17

Hi John

Sorry to hear about your story and thank you for informing other men out there of the risks.
I personally have been taking Propecia 1mg for 8 days now and noticed last night for the first time in my life that had a bad erectile dysfunction and I am definitely going to stop taking the medication and hope that the problem will go away (even though i have also noticed that I started regaining some hair!). can I ask how long have taken Propecia for? Could as short a period as 8 days (in my case) cause permanent side effects?!

Thank you

#18

Here’s an important update:

On 2009-08-10 the Swedish national TV (SVT) news programmes SVT Rapport and SVT Aktuellt showed a news story about the results from the investigation of Propecia conducted by the Swedish MPA. The news story brought up the fact that the Swedish MPA now have concluded that Propecia can cause permanent side effects, despite that Merck Sharp & Dohme has refused to admit this for several years.

  • There is an article about the news story on the SVT website which can be reached at: http://svt.se/2.22620/1.1649111

  • The news story in SVT Rapport was a shorter one, and will be available on the web until 2010-08-10. It can be watched at: http://svtplay.se/v/1649128/rapport/harmedel_tvingas_informera_om_biverkningar

  • The news story in SVT Aktuellt was a longer one (several minutes). It included an interview with a doctor called Ulrik Kvist from Karolinska Institutet, and also a TV studio discussion with Gunilla Sjölin-Forsberg who is head of the side effect unit at the Swedish MPA. There were also comments from a doctor in the US, and a letter from one of the former Propecia users now suffering from permanent side effects was read. The news story also contained parts of an old interview with the former Propecia user Nicholas O´Neill (from a news story about Propecia which SVT showed about 2.5 years ago, or 2006-12-10 more precisely). Unfortunately the news story from 2009-08-10 in SVT Aktuellt was only available on the web until 2009-08-18.

  • Merck Sharp & Dohme refused to attend any of the news programmes. However they have put up a press release on their website with their comments on the matter. The press release can be reached at: http://www.msd.se/content/corporate/press/releasehome/pressreleases/se_press_release_Uttal_Propecia_EU.html

Please note that all of the information referred/linked to above is in Swedish.

#19

John, thanks for the additional info.

I have posted similar details here, with Google translations of the news items:

propeciahelp.com/forum/viewt … 4529#14529

I was not able to locate the Aktuellt video prior to August 18th, and was only aware of the shorter “Rapport” video linked to in the above thread.

Is there any chance you may be able to obtain the longer “SVT Aktuellt” video? Do you have a source who could provide a video clip of it?

#20

The UK’s MHRA has now updated their prescribing information for 1mg Finasteride tablets:

mhra.gov.uk/home/groups/par/ … 054522.pdf
Pg. 7 - "Persistence of erectile dysfunction after discontinuation of treatment with PROPECIA has been reported in post-marketing use."
con054522.pdf (719 KB)