MHRA drug safety update on Finasteride

[splitting hairs]

Hi, I just wanted to make everyone aware of a drug safety update on finasteride, released by the medicines and healthcare regulatory agency (MHRA) - They are the UK equivalent of the FDA.

 

Here's the link:http://www.mhra.gov.uk/SearchHelp/Search/Searchresults/index.htm?within=Yes&keywords=finasteride

 

Basically, there's two things from this, 1) There is now post marketing data to show that Finasteride can cause erectile dysfuction which persists after stopping treatment. If anyone mentioned such a thing in the past, I always shrugged it off because there was no clinical evidence to back it up - but now there is.

 

The second thing is that there is believed to be a risk of male breast cancer. The data, although not statistically significant, is thought to pose an additional risk and therefore is to be added to patient information leaflets soon. Worldwide there have been 50 cases with 5mg finasteride and 3 cases with 1mg finasteride.

 

This second issue is of particular concern to myself, because I have a family history of female breast cancer in my famly.

 

At the moment, I'm still taking propecia but am deliberating over it. Propecia has stopped my hairloss for now, but at 23 I don't think I'm ready to start losing significant amounts of hair again. I'm a bit confused tbh.

[JimJohnson]

thanks for sharing this

[Maxxy]

Personally I will be staying on the drug. I have always been aware of the risks regarding impotence, even though the offical stance has always been "stop and things will return to normal" I had little doubt that for some the condition could remain even if this was more of a mental barrier.

 

The risk of cancer has been floating round for a while now, it is a worry - don't get me wrong, but the numbers seem to be very low. I am in no way trying to play down this finding/belief, however, I remember watching on the news some years go that taking 2 aspirin per week for long periods of time can increase the risk of contracting a specific form of cancer by 60%. Now to me, 60% sounds a large percentage, though it is still widely used.

[TC17]

I really hope HM or cloning comes out soon so that we can all get off these damn drugs.

[Jotronic]

I think if one were to stop and think about 50 cases out of the millions of men that take this medication then the actual real risk is as close to non-existent as any comprehensible percentage points can represent. In fact, I would wager that the chance of getting breast cancer is lower than getting hit by lighting.

 

The danger now is that this thread and others like it will help to fuel the growth of this new "information" into an urban myth that will only feed on itself to get larger.

[Blake Bloxham]

http://www.mhra.gov.uk/SearchHelp/Search/Searchresults/index.htm?within=Yes&keywords=finasteride

 

Did the data show statistical significance for ED? I'd never heard of the male breast cancer risk, and always heard that the sexual disfunction was quite rare/non-significant. Again, thank you for sharing.

[EpilepticSceptic]

I agree with Jotronic; and it's not just because I'm trying to justify using fin

 

I've recently seen some very convincing studies that provide compelling evidence proving that cell phones cause development of brain tumors.

 

How many here so worried about long term fin. effects are going to give up their cell phones ? Not too many I'd suppose. And yet it's highly likely that many more will die from this than from long term fin. usage. And I'd much rather have my hair than a cell phone glued to my ear 24/7 !!

[splitting hairs]

Thanks everyone for your input. Yes, 50 out of millions of patients is very small, and although statistical significance was not reached, the MHRA did feel there was a trend that showed an increaed risk among finasteride users.

 

This is from 10 years of data. Some of us on this forum might be taking this drug for 40+years. We don't know the implications of this.

 

The risk is very small, and it should be borne in mind that a 50 out of several millions is a tiny percentage. But nevertheless, it is still a risk and needs to be considered - especially for guys that have female breast cancer in their family.

 

Jotronic, I understand where you're coming from that this should not be blown out of proportion and I agree with you, however it comes from post marketing data and the risk is still very real. Cancer is not a small issue if it arises.

 

With regard to the sexual dysfunction - i don't know the figures, but they mentioned that it would be updated in the patient information leaflets (probably the UK only).

[Bill - Seemiller]

Splitting hairs,

 

Thanks for presenting this article. While I do tend to agree with JoTronic and wouldn't want to see such statistically insignificant data be blown out of proportion, I do think it's important that the information be presented and discussed. Minimal or not, consumers should be fully informed prior to taking any medication.

 

Best wishes,

 

Bill

[Cam Simmons MD ABHRS]

Originally posted by splitting hairs:

1) There is now post marketing data to show that Finasteride can cause erectile dysfuction which persists after stopping treatment. If anyone mentioned such a thing in the past, I always shrugged it off because there was no clinical evidence to back it up - but now there is.

 

 

splitting hairs

 

Thank-you very much for posting this link. I have read through the full statement.

 

There appears to be a possible but very small increase in breast cancer. The baseline incidence of male breast cancer was said to be 3.8 per 100,000 patient-years and this increased to 7.8 per 100,000 patient years. This implies that for each year that 100,000 patients took Finasteride, 4 more would develop breast cancer than in a similar group who didn't take it. This is still a very small increase overall but there will be closer scrutiny.

 

The only mention of erectile dysfunction was this:

 

Section 4.8 Undesirable Effects

In addition, the following have been reported in postmarketing use: persistence of erectile dysfunction after discontinuation of treatment with PROPECIA;

 

This is reporting. It is NOT clinical evidence.

 

I worked briefly in a men's sexual health centre. Erectile dysfunction is a very common problem that has both physical and psychological causes and often has combined causes. If an 18 year-old has too much to drink on a Friday night and can't get an erection, he may get anxious the next time. The adrenaline released from his anxiety may make it harder for him to get an erection and he will then be even more worried the next time. Viscious cycle. I have seen young guys come in who said they hadn't had an erection for months who took Viagra, Levitra, or Cialis and were fine. Patients would come back later taking just a fraction of a pill. This was not a case of a medication "curing" erectile dysfunction it was a case of someone getting their confidence back. After they realized the dose of the pill was too low to make a difference and that they were really getting erections without medical assistance, they stopped taking pills and were fine on their own.

 

It doesn't make sense to have permanent erectile dysfunction from using a medication that has a temporary effect unless it is psychological. The more anxiety caused by posting about it, the more the anxiety will lead to prolonged erectile dysfunction. I have had patients in my practice who had erectile dysfunction while taking Finasteride but they all got better after they stopped it.

[splitting hairs]

Thank you for your reply Dr Simmons.

 

I too in the past have posted that I thought that a lot of guys experienced erectile dysfunction because of pshychological issues related to the anxiety that is caused by such an effect.

 

This was from my own experience as i had this problem myself after two weeks of propecia - because i was anxious about the prospect experiencing such an effect. After I understood this concept, I haven't had a problem since