Gynecomastia (Enlargement of Breast Tissue) in Men using Finasteride and Dutasteride

Gynecomastia in Men using Finasteride and Dutasteride

It is well known that finasteride and dutasteride can cause enlargement of breast tissue in men. This phenomenon is known as ‘gynecomastia’. It is postulated that hormonal changes that accompany the reduction in DHT (particularly a small 13 % increase in estrogen) may be partly responsible.

New study shows risks greatest with dutasteride

A new study looked at the risk of gynecomastia in men using finasteride for prostate enlargement. The authors used the UK’s Clinical Practice Research Datalink (CPRD) to perform a case control study examining the risk of gynecomastia in individuals using finasteride compared to those who did not use.

The researchers showed that there was a three fold increased risk of gynecomastia in men using finasteride. A 5 fold increased risk of gynecomastia was seen with dutasteride.

Conclusion

It’s clear that these medications can cause gynecomastia. Dutasteride appears to carry greater risk.

Reference

Hagberg et al. Risk of gynecomastia and breast cancer associated with the use of 5-alpha reductase inhibitors for benign prostatic hyperplasia. Clinical Epidemiology 2017; 9; 83-91.

Finasteride for Women

Can Finasteride (Propecia) be used in women?

Finasteride is not FDA approved for women. That does not mean we never use finasteride in women - in fact, I sometimes to prescribe this medication. The fact that it is not FDA approved just alerts us that there are important reasons to consider as to why it is not approved.  

 

Does FDA approval matter?

FDA approval does matter. It directs us to consider that considerable review has been done to evaluate that safety of a given medication. However, readers must keep in mind that 99 % of the medications that a hair loss doctor uses are not FDA approved!! When a medication that is not FDA approved is used, we say that this is a so called 'off label' use. 

When I use minoxidil for alopecia areata, I'm using the medication in an 'off label' manner. Minoxidil is not FDA approved for alopecia but but sure can help many patients.  In fact - there is not a single medication on the planet that is FDA approved for alopecia areata.

When I use Plaquenil for lichen planopilaris, I'm using the medication in an 'off label' manner. Plaquenil is not FDA approved for lichen planopilaris but but sure can help many patients.  In fact - there is not a single medication on the planet that is FDA approved for lichen planopilaris.

When I use clindamycin for folliculitis decalvans, I'm using the medication in an 'off label' manner. Clindamycin is not FDA approved for folliculitis decalvans but but sure can help many patients.   In fact - there is not a single medication on the planet that is FDA approved for folliculitis decalvans.

When I use minoxidil and steroid injections for traction alopecia, I'm using these medications in an 'off label' manner. Minoxidil and steroid injections are not FDA approved for traction alopecia but but sure can help many patients. In fact - there is not a single medication on the planet that is FDA approved for traction alopecia.

Finasteride for Women - It's off label.

When I use finasteride for androgenetic alopecia in women, I'm using these medications in an 'off label' manner. Finasteride is not FDA approved for androgenetic alopecia but but sure can help many patients. 

Some medications are appropriate for a given patient others are not. One really needs to sit down with a physician and discuss. Even Rogaine is not advised for some women (heart conditions, heart rhythm problems, pregnancy, other hormone abnormalities such as pheochromocytoma). 

Some physicians never prescribe finasteride to women regardless of age. Some physicians only prescribe to post menopausal women. Some physicians will prescribe to premenopausal with appropriate counceling on the risks during pregnancy and prescription of appropriate birth control.  

Finasteride must never be used by women who may become pregnant. Women with strong histories of estrogen dependent cancers (breast, ovarian, gynaecological cancers) should also review use with their doctors. This includes breast, ovarian and other gynecological cancers. Women with depression should also have a thorough discussion as to whether this drug is appropriate for them of not.

Dutasteride for Male Pattern Balding: New study point to low incidence of side effects

Dutasteride, a dual inhibitor or 5 alpha reductase type 1 and 2

Dutasteride is approved in Korea for the treatment of male pattern balding. It is used "off label" in many other countries. Whereas finasteride (Propecia) inhibits 5 alpha reductase type 2, dutasteride inhibits 5 alpha reductase types 1 and 2.

Finasteride has received press on account of its side effect profile (especially sexual side effects) and possibilities of long lasting, possibly permanent side effects in a low proportion of users.  

Dutasteride is known to have a similar array of overall side effects, and given the greater inhibition of 5 alpha reductase that dutasteride has, one might expect a similar if not greater number of side effects. Interestingly, this has not been the case in all studies to date. In fact, most studies support the efficacy and tolerability of dutasteride at 0.5 mg with relatively low incidence of side effects.

New study

A new study published by Choi et al looked at over 700 men ranging in age from 18-41. These men were using dutasteride at 0.5 mg. The frequency of side effects were low. 1.3 % of patients experienced decreased libido, impotence in 1 %, fatigue in 0.7 %, breast enlargement was seen in 0.3 %. Over 79 % of men reported improvement with their hair.

FINAL COMMENT

This study was not set up to compare dutasteride to placebo. This was simply an observational study as part of routine "post marketing" surveillance. Overall, the findings are encouraging and expected- pointing to a low risk of adverse events with this dual inhibitor of 5 alpha reductase.

 

REFERENCE

Choi GS et al. Ann Dermatol. 2016 Aug;28(4):444-5

New Roles for the Hair Loss Drug Finasteride: Treating Heart Failure

A Drug for Hair Loss, Prostate Enlargement ... and Maybe Heart Failure!
 

It is well known that androgen hormones like dihydrotestosterone (DHT) have an important role in hair loss in those who are genetically predisposed. Recent scientific evidence also indicates that androgen hormones like testosterone or the more potent dihydrotestosterone (DHT) contribute to the development of heart failure. About 700,000 individuals die of heart disease in the USA and Canada every year.

Does blocking male hormones help improve heart failure?

Researchers from Germany recently set out to design a study to determine whether anti-androgenic therapy with the drug finasteride improves the ability of the heart to function under states of heart failure. Instead of studying humans, the researchers studied mice with heart failure.

What did the researchers find?

The researchers found the heart function was markedly improved in response to treatment with finasteride in mice. In addition, finasteride treatment also allowed mice with heart failure to live longer.  

Final Conclusions

The researchers concluded that finasteride has the potential to reverse heart failure in mice and could be a potential therapy for human trials in the future 

Reference

Zwadio C et al. Anti-Androgenic Therapy with Finasteride Attenuates Cardiac Hypertrophy and Left Ventricular Dysfunction. Circulation. 2015 Jan 28. 

Dutasteride and Finasteride: New data suggests no Link with breast cancer in men

Dutasteride and Finasteride: Do they cause breast cancer?

Finasteride (Propecia) and dutasteride (Avodart) are prescribed for the treatment of male pattern baldness. Many of my male hair transplant patients receive finasteride or dutasteride in order to help reduce the progression of balding in existing hairs.  

Finasteride and dustasteride belong to a group of drugs called "5 alpha reductase inhibitors." They block the enzyme 5 alpha reductase and decrease the levels of the potent androgen hormone DHT (dihidrotestosterone). In addition to reducing DHT, the drugs increase the levels of estrogen slightly which has raised questions from physician and researchers around the world as to whether these drugs increase the risk of breast cancer in men.

US researchers set out to examine the relationship between the use of 5 alpha reductase inhibitors and male breast cancer. They studied men using the higher 5 mg dose of finasteride used in prostate enlargement (rather than the 1 mg dose used in hair loss) and the 0.5 mg dose of dutasteride.  They looked at the use of these drugs in 339 men with breast cancer and 6,780 men without breast cancer.

What were the findings and conclusions from the study?

The authors did not find an association between using 5 alpha reductase inhibitors and the development of breast cancer in men. Overall, the authors concluded that the "development of breast cancer should not influence the prescribing of 5 alpha reductase inhibitor therapy."

Reference

Bird ST et al. Male breast cancer and 5 alpha reductase inhibitors finasteride and dustasteride. J Urology; 190:1811-4

Benefits of Combining Minoxidil and Finasteride

Benefits of Combining Minoxidil and Finasteride

Minoxidil and Finasteride are two FDA approved treatments for hair loss. Minoxidil is a topical solution that is rubbed on the scalp and finasteride is an oral treatment (pills). Many men with genetic hair loss (androgenetic alopecia) consider the use of these medications and may consider hair restoration as a more permanent solution.

Both minoxidil and finasteride have their own set of side effects. Finasteride, however, is much more effective. GIven that these two agents are clinically proven to help with hair loss, I'm often asked - "Is it better to use both of these products or should I just pick one?"

Combination Minoxidil and Finasteride better than single treatment

The answer is - 'yes.' There is clinical evidence that men using finasteride for hair loss who add minoxidil to their treatment plan have a slightly better result than men who only use finasteride. The benefits, however, are small. It makes sense that the two medications act synergisticially in treating hair loss given that they act differently. Minoxidil helps hair growth by directly stimulating the hair follicle. In contrast, finasteride works by blocking the action of the potent male hormone dihydrotestosterone or "DHT". 

Conclusion

Both minoxidil and finasteride should be considered. For men with early hair loss, the use of both might help and may be considered prior to a hair transplant. Minoxidil and finasteride have less benefit for men with advanced hair loss. In these cases, a hair transplant is the primary treatment.

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Finasteride Use by Young Men: Not only for Baldness in the Crown !

Finasteride Use by Young Men

For years, we've largely assumed that finasteride helps men with hair loss in the crown, but does little for men with hair loss in the front of the scalp or the temples.

A new study by US researchers has nicely shown that finasteride 1 mg daily can help young men with male pattern balding regardless of where on the scalp the man has hair thinning.

The researchers studied men 18 to 60 years of age for a period of two years. Four areas of the scalp were examined: (1) vertex (crown), (2) the mid-scalp, (3) the frontal hair line and (4) the temples.

What were the results of the study?

The study showed that young men benefitted from taking finasteride - regardless of where there hair thinning occured. Young men (age 18-40) with hair loss in front, temples, mid-scalp or crown all had benefit from taking finasteride. However, the same was not true of men age 41-60. Men in this slightly older group benefitted most if their hair loss was in the crown and the mid-scalp.

Reference

Olsen EA et al. Global photographic assessment of men aged 18 to 60 with male pattern hair loss receiving finasteride 1 mg or placebo.  J Am Acad Dermatol 2012; 67: 379-86. (click for abstract)

 

New Health Canada Warnings about Finasteride, Dutasteride and Prostate Cancer

Prostate cancer is one of the most commonly diagnosed cancers in men. In fact, about one in six men will be diagnosed with prostate cancer. One new case of prostate cancer occurs every 2.2 minutes and a man dies from prostate cancer every 15.6 minutes.

Health Canada released a statement last week about the possible increased risk of “high-grade” (aggressive) prostate cancer in men taking the drugs finasteride and dutasteride.  Both of these drugs are used to treat male balding but are also used to treat men with enlarged prostate glands. Large numbers of my patients have asked me about the Health Canada statement in the past weeks –  Click on the link to read more about the Health Canada statement.

READ THE HEALTH CANADA STATEMENT

In order to understand the meaning of the Health Canada warning about finasteride and dutasteride, it’s important to have some background information.  First, it’s important to know that there were TWO very large studies conducted a few years ago (one in 2003 and one in 2008) looking at whether finasteride and dutasteride could actually help prevent prostate cancer in men. 

The two reserach studies are:

STUDY 1: Prostate Cancer Prevention Trial (or ‘PCPT’ Trial)

• This was a 2003 study of 18,000 men over 55 years of age
• This study showed finasteride reduced the risk of men getting prostate cancer by 25 %
• There was a slight increased in high grade (more aggressive) prostate cancers in men who took the drug compared to those who took the placebo (sugar pill)
• The dose of finasteride in this study was  five times higher dose of finsasteride than used for hair loss (i.e. 5 mg rather than 1 mg)

STUDY 2: Reduction by Dutasteride of  Prostate Cancer Events (or REDUCE Trial)

• This was a study in 2008 of over 6700 men age 50 to 75
• Over the 4 years of the study, there as a 23 % reduction in prostate cancer in men who took the drug
• There was a slight increase in high grade (more aggressive) prostate cancers  in year 3 and 4 in men who received the drug compared to men who received the placebo (sugar pill) but overall the raw data showed there was no increase risk of high grade cancers throughout all years of the study.
• The dose of dutasteride was the same as used for hair loss (i.e. 0.5 mg)

THINGS THE PUBLIC SHOULD BE AWARE OF:

• The data from these two studies is complicated to interpret
• There is no question whatsoever that finasteride and dutasteride both reduce the risk of men getting prostate cancer.
• What is not entirely clear is if these two drugs increase the chance of men getting a "high grade" cancer.  It’s possible that for every four low-grade (non aggressive cancers) that these drugs prevent, there is one high grade cancer that gets detected while on the drug.

But do these drugs make it "easier" to detect a cancer that would have otherwise escaped detection?

OR

Do these drugs actually contribute to the development of the prostate cancer?

The answer to these questions is not known with complete certainly.  There are several explanations as to why more high grade prostate cancers were detected in men who took the drug.  For the most part, most authorities in prostate cancer do not believe there is a cause for alarm. In fact, the number of world authorities on prostate cancer who believes there could be a link between finasteride and prostate cancer is greatly outnumber by authorities who feel there is no link whatsover.  This includes Dr Otis Brawley, Chief Medical Officer of the American Cancer Society and Dr Neil Flesher, Head Division of Urology at the University Health Network and Professor of Surgery at the University of Toronto. The public needs to know this information is not cut and dry.

FINAL THOUGHTS

• If there is any risk of high grade prostate cancer with these drugs (again, we can't say for sure there even is).... the risk is very small.
• The public should be aware that the new Health Canada warnings do not state that finasteride or dutateride causes high grade prostate cancer. Rather, the warning states that there could be a link and more studies are needed.
• The studies discussed above were conducted with five times higher dose of finsasteride than used for hair loss (i.e. 5 mg rather than 1 mg).  Therefore, Propecia (finasteride 1 mg) was not included in these studies
• The dose of dutasteride in these studies was the same as used for hair loss (0.5 mg)
• Individuals with concerns about these drugs should speak to their doctors

 

Finasteride: Does it Increase the Risk of Breast Cancer in Men?

Health Canada issued a news release August 4, 2011 advising doctors and the public of the possibility of breast cancer in men using the oral medication finasteride. Finasteride at 1 mg is used approved for the treatment of hereditary hair loss in men and is marketed under the name Propecia. Finasteride at a 5 mg dose is used for the treatment of enlarged prostate in men and is marketed under the name Proscar. Although the drug is sometimes prescribed off-label to treat women with androgenetic alopecia, it is not FDA approved for women.

Reports of a possible association between finasteride and male breast cancer are not new.  The possibility of this association was raised over 10 years ago.  There are now at least 50 previous reports in the medical literature about men who developed breast cancer while taking finasteride at the 5 mg dose. There are at least 3 reports in the literature of men who developed breast cancer taking the 1 mg dose. 

Overall, breast cancer in men is rare. 99 % of breast cancers are diagnosed in women and 1 % are diagnosed in men.  Each year about 2000 new cases of male breast cancer are diagnosed in the United States and 200 cases are diagnosed in Canada. 

The public needs to be aware that these studies do not prove that finasteride causes breast cancer in men. This relationship is not known at the present time and more research is needed.  However, it remains a possibility.    The Health Canada report states:

Based on the currently available evidence, it is not known with certainty whether finasteride can cause breast cancer, nor can this possibility be ruled out at this point in time.

All men starting finasteride should be aware of the possibility that reports of breast cancer have rarely occurred in men taking finasteride.  The risks in women are unknown at the present time. Health Canada has advised individuals who take finasteride to report changes in their breasts to their doctors. These changes would include:

• Enlargement of the breasts
• Lumps in the breasts
• Tenderness or pain in the breasts
• Discharge from the breasts

 The Health Canada report is found in the following link:

Finasteride (Propecia, Proscar): Potential rare risk of breast cancer in men