finisteride and male breast cancer

[LCDScreenforehead]

hi there, i recently got off the phone with my pharmacist who supplies me my propecia, and he seemed genuinely concerned about the possibility of some1 chances of male breast cancer increasing by taking propecia, i was pritty concened as well because its the first time iv heard of it, he told me that recently about 1 week ago the companies that produce finisteride are unsure weather it increases or decreases breast cancer he asked me whether i wanted to continue taking the propecia and i told him i'd think about it so far i'v looked on the web and found nothing, the only thing that has come to my attention is a few cases of breast enlargement in males when they were on 5mg proscar but iv been unable to find any cases on individuals whov gone on to have breast cancer, i'm a pritty young guy, and altough i'm on the standard 1mg propecia it is quite worrying news nevertheless

 

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http://www.telegraph.co.uk/health/h...ed-prostate-linked-to-male-breast-cancer.html

Drug for enlarged prostate linked to male breast cancer - Dec 2009

A drug taken by up to 100,000 men for enlarged prostate has been linked to breast cancer in men, the UK medicines regulator has said.


By Rebecca Smith, Medical Editor
Published: 6:50PM GMT 03 Dec 2009

New warnings will be added to the packaging of Finasteride after five men in Britain taking the drug developed breast cancer.

An analysis by the Medicines and Healthcare products Regulatory Agency found a total of 53 men worldwide on the drug had developed breast cancer.

The report from the MHRA said: "Cases of male breast cancer have been reported for finasteride, and the review suggested that an increased risk of male breast cancer associated with finasteride use cannot be excluded.

"Patients using finasteride products should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain or nipple discharge because these may be signs of a serious condition, such as breast cancer.

"On the basis of the review, it was recommended that a warning on the risk of breast cancer should be included in the product information for all medicines containing finasteride."

The drug is used for the treatment of benign prostatic hyperplasia, also known as enlarged prostate, which is not cancerous but does cause symptoms such as difficulty passing urine.

Finasteride is known to cause gynaecomastia in men, the enlargement of male breast tissue, and this is thought to be connected to the reports of breast cancer in men because men who develop the condition are more likely to have their chests checked by doctors.

The condition is found in half of all men aged between 51 and 60 and is more common in older men.

Lord Mandelson received treatment for the condition earlier this year.

It is thought around 100,000 men in England and Wales could be taking finasteride, also known in Britain as Proscar and Propecia.

The drug has been under close review since 1998 works by preventing testosterone from being used by the body and this shrinks the prostate gland.

Less than one per cent of the 45,500 cases of breast cancer diagnosed each year in Britain are in men and the condition is very different in men.

There are around 300 men diagnosed with breast cancer in Britain annually.

 

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The FULL 27 page MHRA finasteride/male breast cancer findings in Dec 2009:

http://www.mhra.gov.uk/home/idcplg?...Name=CON065504&RevisionSelectionMethod=Latest

 

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This large 7 year Finasteride trial involving 18,882 men was stopped in March 2003 because they found it promoted high-grade prostate cancer:

Finasteride (Propecia) and the Promotion of High-Grade Prostate Cancer - 2004
http://content.karger.com/ProdukteDB/pr ... =87057.pdf
W.R. Pitts, Jr.
[Archives of Dermatology 2004;140:885 - 886]

Correspondence: The phase 1 trials of fi nasteride (Propecia/Proscar; Merck) have shown that fi nasteride at 1 mg (Propecia) as well as fi nasteride at 5 mg (Proscar)
blocks 5-reductase. The genetic, biochemical, epidemiological, experimental, and clinical reasons for my warning [1, 2] 3 years ago that use of finasteride promotes prostate cancer have been confirmed by the findings of a finasteride chemoprevention trial [Prostate Cancer Prevention Trial (PCPT)] involving 18,882 men followed up for 7 years.

The trial was stopped after 9,060 men underwent biopsy during the trial or at the end of 7 years. It was found that 'finasteride prevents or delays the appearance of prostate cancer' by 24.6% [finasteride, 803/4,368 (18.4%); placebo, 1,147/4,692 (24.4%)] but 'increased the risk of highgrade prostate cancer' by 67% [finasteride, 280/757 (37%); placebo, 237/1,068 (22.2%) (p  0.001)] in men diagnosed as having prostate cancer.

At 7 years 52% of the tumors in the finasteride treated men were high grade vs. 31% in the placebo group... If one looks at the positive biopsy rate in the patients with an elevated PSA (prostate-specifi c antigen) or abnormal digital rectal examination (DRE) (i.e. biopsied 'for cause'), fi nasteride only reduced the positive biopsy rate in those patients by 10% (29.5% placebo vs.26.5% fi nasteride).

The 'end of study' biopsies of the men who did not undergo biopsy during the 7 years (no PSA 4.0 ng/ ml, no induration on DRE) showed a 60% increase in high-grade prostate cancer [fi nasteride, 92/364 (25.3%); placebo, 89/564 (15.8%) (p  0.001)].

Even with intensive screening, high-grade prostate cancer was promoted without warning by finasteride (Propecia). The suggestion by Dr. Peter Scardino in his editorial in the New England Journal of Medicine that young men (35 years old) might have the 'added benefit of cancer prevention' is not correct, as these men will have the added risk for promoting high-grade prostate cancer for over 50 years while using finasteride, 1 mg (Propecia, 1 mg).

Principal investigator Ian M. 'Thompson, MD, also confused the issue of lowdose finasteride (Propecia, 1 mg) and high-dose finasteride (Proscar, 5 mg) (Oncology Times, July 25, 2003, and August 10, 2003). The PCPT was stopped in March 2003 because finasteride promoted high-grade (Gleason scores 7, 8, 9, 10) prostate cancer. Dermatologists should heed the warnings of the PCPT and cease using Propecia (finasteride) and nonprescription blockers of 'the bad body chemical DHT [dihydrotestosterone]' (e.g., Hair Advantage, Avocor) for alopecia.

 

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The Swedish Medical Product Agency, already have a breast cancer warning planned for BOTH 1mg and 5mg finasteride:

http://www.lakemedelsverket.se/PageFile ... teride.Doctor

18 Nov 2009

In accordance with decision in CHMP Pharmacovigilance Working Party, within the PSUR Work Sharing Procedure, it is recommended that the medicinal products including finasteride 1 mg and 5 mg should be updated with information concerning breast cancer in section 4.4 and section 4.8 in the SPC, and the PIL.

The following text should be implemented:

Finasteride 1 mg
4.4
Breast cancer has been reported in men taking finasteride 1 mg during the post-marketing period.
Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynecomastia or nipple discharge.

4.8
In addition, the following have been reported in postmarketing use: Ppersistence of erectile dysfunction after discontinuation of treatment with Propecia; male breast cancer (see section 4.4 Special warnings and precautions for use). has been reported in post-marketing use.

PIL for Propecia
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer

---------------------------------------------------------------

Finasteride 5 mg

4.4
Breast cancer in men
Breast cancer has been reported in men taking finasteride 5 mg during clinical trials and in the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynecomastia or nipple discharge.

4.8
In addition, the following has been reported in clinical trials and post-marketing use; male breast cancer (see 4.4 Special warnings and precautions for use).

PIL for Proscar
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.

 

[dougfunny]

This large 7 year Finasteride trial involving 18,882 men was stopped in March 2003 because they found it promoted high-grade prostate cancer:

Finasteride (Propecia) and the Promotion of High-Grade Prostate Cancer - 2004
http://content.karger.com/ProdukteDB/pr ... =87057.pdf
W.R. Pitts, Jr.
[Archives of Dermatology 2004;140:885 - 886]

Correspondence: The phase 1 trials of fi nasteride (Propecia/Proscar; Merck) have shown that fi nasteride at 1 mg (Propecia) as well as fi nasteride at 5 mg (Proscar)
blocks 5-reductase. The genetic, biochemical, epidemiological, experimental, and clinical reasons for my warning [1, 2] 3 years ago that use of finasteride promotes prostate cancer have been confirmed by the findings of a finasteride chemoprevention trial [Prostate Cancer Prevention Trial (PCPT)] involving 18,882 men followed up for 7 years.

The trial was stopped after 9,060 men underwent biopsy during the trial or at the end of 7 years. It was found that 'finasteride prevents or delays the appearance of prostate cancer' by 24.6% [finasteride, 803/4,368 (18.4%); placebo, 1,147/4,692 (24.4%)] but 'increased the risk of highgrade prostate cancer' by 67% [finasteride, 280/757 (37%); placebo, 237/1,068 (22.2%) (p  0.001)] in men diagnosed as having prostate cancer.

At 7 years 52% of the tumors in the finasteride treated men were high grade vs. 31% in the placebo group... If one looks at the positive biopsy rate in the patients with an elevated PSA (prostate-specifi c antigen) or abnormal digital rectal examination (DRE) (i.e. biopsied 'for cause'), fi nasteride only reduced the positive biopsy rate in those patients by 10% (29.5% placebo vs.26.5% fi nasteride).

The 'end of study' biopsies of the men who did not undergo biopsy during the 7 years (no PSA 4.0 ng/ ml, no induration on DRE) showed a 60% increase in high-grade prostate cancer [fi nasteride, 92/364 (25.3%); placebo, 89/564 (15.8%) (p  0.001)].

Even with intensive screening, high-grade prostate cancer was promoted without warning by finasteride (Propecia). The suggestion by Dr. Peter Scardino in his editorial in the New England Journal of Medicine that young men (35 years old) might have the 'added benefit of cancer prevention' is not correct, as these men will have the added risk for promoting high-grade prostate cancer for over 50 years while using finasteride, 1 mg (Propecia, 1 mg).

Principal investigator Ian M. 'Thompson, MD, also confused the issue of lowdose finasteride (Propecia, 1 mg) and high-dose finasteride (Proscar, 5 mg) (Oncology Times, July 25, 2003, and August 10, 2003). The PCPT was stopped in March 2003 because finasteride promoted high-grade (Gleason scores 7, 8, 9, 10) prostate cancer. Dermatologists should heed the warnings of the PCPT and cease using Propecia (finasteride) and nonprescription blockers of 'the bad body chemical DHT [dihydrotestosterone]' (e.g., Hair Advantage, Avocor) for alopecia.

This was debunked in 2007 or so. Turned out doctors were just more likely to find the cancer on a smaller prostate - it was no more common.

I really believe the breast cancer risk. If this stuff is growing breast tissue, which clearly it does occasionally, it stands to reason you are now a candidate for breast cancer.

Sounds logical enough that it is due to an increase of estrogen. That is a big contributor to breast cancer in women. I think I'll be getting my estrogen levels checked for sure...

By far the scariest side effect yet I must say!

 

[dougfunny]

I really believe the breast cancer risk. If this stuff is growing breast tissue, which clearly it does occasionally, it stands to reason you are now a candidate for breast cancer.

Sounds logical enough that it is due to an increase of estrogen. That is a big contributor to breast cancer in women. I think I'll be getting my estrogen levels checked for sure...

By far the scariest side effect yet I must say!

The link between Finasteride and Breast cancer may simply be a correlation because men who take Finasteride are often more likely to get their chests checked by doctors. ''Finasteride is known to cause gynaecomastia in men, the enlargement of male breast tissue, and this is thought to be connected to the reports of breast cancer in men because men who develop the condition are more likely to have their chests checked by doctors.''

Now I could see that leading to earlier diagnoses and hence better survival rates, but to my knowledge breast cancer is like any other cancer - it kills you!

It will spread, and you will die.. so at some point before you die you will probably visit a doctor who will do a test to figure out why you are incredibly sick and find cancer. If you don't you will die and the doctor will look into why and find you had cancer.

High blood pressure is the kind of thing that goes undiagnosed, not cancer.

 

[dougfunny]

The quote that I cited was from the original research study that found the correlation. Either way the study only found a total of five men who had cancer which was an extremly small minority of the test subjects and hardly evidence to draw such a serious conclusion from.

That is still .3 percent, a 300% increase over what would be expected in the population.

Now if there were no other evidence pointing to a link between breast cancer and finasteride I might buy the unlikely but possible chance that 3 or 4 unlucky men got breast cancer that statistically should not have.

But when there is a good explanation for the breast cancer I think we have to take it more seriously.

It's a fact that gynomastia is one of the most common side effects with this drug.

It's also a fact that people with gynomastia are several times more likely to get breast cancer.

And it's a fact that men with with high extrogen levels are several times more likely to get breast cancer.

Taken from the Journal of Nation Cancer Institute: http://jnci.oxfordjournals.org/cgi/repr ... /4/338.pdf

"An example of increased rates of male breast cancer associated with increased estrogen-to-testosterone ratios can be seen in men with Klinefelter’ s syndrome, who are 50 times more likely to develop breast can- cer than their normal counterparts (4). This ratio may be affected by finasteride (Proscar)."




The only positive and somewhat ironic thing is that I suppose this increase could be off set by a supposed 30% decrease in chance of Prostate cancer, but this is only if the increase in chance of breast cancer is 10x or less. If it is 50x we're screwed.

Statistically you have a 3% chance of dying from Prostate cancer and 1/10 of 0.1% of a chance of dying of breast cancer.

With Propecia, if we assume a 10x increase in probability of breast cancer, your chances are now 2% of dying from Prostate cancer and 1% from breast cancer.So your chances of dying of cancer are no greater than if you took no finasteride.

If the increased probability is less than 10x, then you would be less likely to die of cancer overall.

But if it is a 50x increase like in Kleifners syndrome, your chances of dying from breast cancer rocket to 5% and you chance of dying from cancer more than doubles from 3% to 7%.

But then again 30% of people get gyno in Kleifners, versus like 2% in finasteride. So a less than 10x increase seems quite probable, in which case this is no big deal and the chance of breast cancer is outweighed by the smaller probability of prostate cancer.

Something to think about...

 

[dougfunny]

It's a fact that gynomastia is one of the most common side effects with this drug.

Actually that's not true..Gynomastia is not the most common side effect. The most common side effects are, Erectile Disfunction, Testicular Pain, and change in semen viscosity, and loss of libido. Side effects such as Gyno only effect a minute fraction of Finasteride users, by no meens is Gyno '' One of the most common side effects''.

Never said it was the most common, but "one" of the most common is true. It's almost always in the top 5 in both finasteride and dutasteride studies. Usually around 2%, which is hardly a minute fraction.

 

[dougfunny]

Well I consider 2% to be a fraction in comparison to the 98% who do not experiance Gyno.

Fair enough, but the 24,000 people that got gyno (2% of 1.2 million users) probably do not...