Benign prostatic hyperplasia
Benign prostatic hyperplasia (a.k.a. BPH) is an enlargement of the prostate gland, present in males. It is a non-cancerous condition where an overgrowth of prostate tissue (due to excess cell replication) pushes against the urethra and the bladder, which block the flow of urine and causes pain. The cause of it is unknown, but it has been connected with the levels of male hormones in the body and their imbalance. It is a disease associated with the aging process, because above 95% of men above 80 years old have it and above 70% of men above 65. There are two drug classes used for the treatment of BPH – alpha-blockers and 5-alpha-reductate inhibitors. Alpha blockers are more effective and are usually prescribed first.
Beyond BPH Treatment. Can finasteride cause male breast cancer?
There are two sides to this story.
One, benign prostatic hypertrophy or hyperplasia, a complicated medical term which just means non-cancer related enlargement of the prostate gland which is a relatively common occurrence among the adult male population. Risk factors for developing benign prostatic hyperplasia include age, a relative or a family member having the same illness, or a person’s current medical condition. Obesity, cardiovascular or circulatory diseases, diabetes and hypertension all curtail an increased risk of developing benign prostatic hyperplasia. Chances are, by age 60, there is a 50% chance that men will have this condition and by age 85, as much as 90% of men will be affected by benign prostatic hyperplasia.
On the other side, male breast cancer, a not-so-complicated term which undoubtedly means that this disease is CANCER. But who has male breast cancer anyway? Most people probably have not heard that this form of cancer exists. In 2008, the United Kingdom registered only about 1% of the newly diagnosed 48,034 breast cancer cases were found in men. Statistically speaking, in a worldwide incidence, only one soldier in an army of a thousand will have breast cancer. Risk factors for developing male breast cancer include age; high estrogen levels, either through taking hormonal medications or being exposed to estrogens in the environment; obesity; alcoholism; liver disease; strong family history of breast cancer; congenital anomalies or diseases like Klinefelter syndrome; radiation exposure, particularly those who are exposed to abnormal levels of radiation early in life or at least before the age of thirty for those requiring radiation therapy at or near the chest area for treatment of another disease. Contrary to previous beliefs, male breast cancer has a similar survival profile compared to those of women suffering from breast cancer.
So, why is there and association with breast cancer and finasteride? Although clinically proven to be very effective in treating benign prostate hyperplasia, researchers have found an equivocal link to treatment with finasteride and male breast cancer. Evidence of the association with finasteride to male breast cancer was revealed in the MTOPS (Medical Therapy of Prostatic Symptoms) study. Because of this, regulatory boards from different nations have issued warnings for this possible risk of developing breast cancer when taking finasteride for benign prostatic hyperplasia.
Should men taking finasteride be wary about developing breast cancer? Read on.
Pharmaceutical companies don’t just manufacture drugs and then release it for public consumption without thorough testing. A significant portion of the price that you pay for a particular drug covers for the finances necessary to fund research and testing during development of medications. After research and development have been completed, the drug then undergoes animal testing and then testing on humans. Pharmaceutical companies are required by law to do everything under their power to make medicines fit for human consumption and they are directed by law to withdraw medications which have undesirable effects on human patients once out on the market.
With the rapid advancement of treatment modalities, newer classes of drugs are highly target-specific. One reason for this target-specificity is to minimize complications and adverse effects. People born from the 70’s would tell you that they used to take just one medication for fever, headache, flu, back pain, insomnia and probably for toothache as well. Did they ever tell you the story about how they felt after taking that remedy? One-hit pills aren’t the answer. Theoretically speaking, drugs with several desired effects have an equal number, or maybe even more, of undesirable effects.
Your blood pressure-lowering medication, your cholesterol-lowering medication, the medication you take when you are having a bad day, all these medications have side-effects. Read through the product insert of ibuprofen and you will be surprised. You can read about the side-effect profile of Proscar in a different article found in this website.
Because of this association with male breast cancer, Proscar had to undergo further trials to see if this association with male breast cancer has any relevance. From the year 2000 up to 2009, only a handful of trials were undertaken to look into this association of male breast cancer and finasteride. As of November 2009, Merck Sharp and Dohme, the manufacturer of Proscar (finasteride), received 53 reports of male breast cancer occurring with or after treatment for benign prostatic hyperplasia with their drug. They reported that of the 53 patients, 28% were found to be inadequately reported due to the fact that the onset of development of male breast cancer could not be determined in this group; the other 72% reported that the onset of breast cancer coincided with the use of Proscar.
Possible explanations to the biological mechanism to the increased risk of breast cancer while under treatment with Proscar could be related to the direct action of the drug on type II 5α-reductase inhibition resulting in an increase of testosterone levels bringing about an increase in estradiol levels. An increase in estrogen levels in men could be the possible explanation to this link with male breast cancer.
Results of all these trials were generally inconclusive. Whether or not Poscar had something to do with the development of male breast cancer, it was not proven to have a strong association with male breast cancer. Reports from Health Sciences Authority revealed that there were no new cases of male breast cancer being reported since 2009. The same regulatory board is continually working with the manufacturers of Proscar to update local package inserts to include warnings about Proscar’s association with male breast cancer.
For that reason, Proscar continues to be available for consumers worldwide as an effective treatment for benign prostatic hyperplasia. Health care workers are therefore advised to caution patients of the possibility of developing male breast cancer when taking Proscar and to advise patients to seek medical attention if they notice changes in the size of their breasts, to note if there are secretions from the areola or skin discolorations surrounding the area of the breast.
So, would you start or continue to take Proscar for treatment of your benign prostatic hyperplasia? Current evidence would point towards saying yes to that question provided that you are made fully aware of the beneficial effects, side-effects and possible complications of taking the drug. If there was a strong association between Proscar and the development of male breast cancer, then this medication would have been pulled out from the market.
Complications that would arise from untreated or inadequately treated benign prostatic hyperplasia are far more common than developing male breast cancer while receiving Proscar. Complications can range from urinary retention; stone formation in the bladder or kidneys; recurrent urinary tract infection; kidney failure and infection brought about by the obstruction to urine flow due to the enlarged prostate gland creating a high backward pressure being exerted on the kidneys; depression or anxiety from having to wake up frequently from sleep just to go to the bathroom; not to mention the high cost of having to seek medical attention frequently due to these complications. Complications that may arise from depression would include drug dependence from medications used to treat depression with its accompanying drug dose tolerance; poor control of hypertension, if you are hypertensive or you may develop stress-induced hypertension. You may observe that you function poorly during the day.
Having to undergo surgery for removal or resection of all or part of the prostate gland carries multiple risks as well. Risks during the procedure would range from bleeding to poor wound healing and infection, necessitating longer periods of stay in the hospital, stronger and more expensive antibiotics, higher doses of pain killers and not to mention the high cost of paying for doctors’ fees. Postoperative complications, to name a few, range from retrograde ejaculation which happens when the muscle that is involved in ejaculation is cut and the sperm would travel back towards the urinary bladder instead of outwards through the urethra; late onset infection; blood in the urine; and probably the most undesirable, impotence.
There is also the risk of developing prostate cancer if benign prostatic hyperplasia is left untreated or inadequately treated. The risk of developing prostate cancer is probably higher for untreated or undertreated benign prostatic hyperplasia than the risk of developing male breast cancer while taking medications for benign prostatic hyperplasia, like Proscar.
Bear in mind that not all patients react the same way to a particular medication, in this case Proscar. It is wise to seek medical attention once you notice any unusual development of new symptoms even when you think that it is not caused by Proscar or any drug for that matter. Adverse effects listed in the drug literature lists effects that are commonly seen in a certain population taking that particular drug. It does not list ALL adverse effects.
With treating diseases, health care workers go by the saying “benefits should outweigh the risks”. With that in mind, the benefits of taking Proscar for treatment of benign prostatic hyperplasia far outweighs the risk of developing male breast cancer.
1. Gynecomastia and Breast Cancer during Finasteride Therapy. N Engl J Med 1996; 335:823September 12, 1996
2. Breast cancer in men. http://www.cancer.org/acs/groups/cid/documents/webcontent/003091-pdf.pdf
3. Breast cancer – UK incidence statistics. Cancer research UK. http://info.cancerresearchuk.org/cancerstats/types/breast/incidence/
4. Hemant Kumar Bid, Rituraj Konwar, Vishwajeet Singh. Benign prostatic hyperplasia: is it a growing public health concern for India?
5. Diane K. Wysowski, Ph.D.Evelyn Farinas, R. Phd. Finasteride in Benign Prostatic Hyperplasia
6. Health Sciences Authority. Singapore.
7. Journal of the National Cancer Institute, Vol. 96, No. 4, February 18, 2004. Male breast cancer during finasteride therapy.
Products: Benign prostatic hyperplasia therapy agents
Flomax belongs to a group of alpha adrenergic blockers and is used for the treatment of symptoms of benign prostatic hyperplasia. The recommended dosage is 0.4 mg per day. Flomax works by relaxing the muscles of prostate and bladder neck there by making it easier to urinate, because in men urethra, the tube which carries urine from the bladder to the penis travels through the prostate gland. When men get older, the prostate gland enlarges and the muscle cells within the prostate gland and the neck of the bladder, which control the flow of urine, tighten. It is recommended not to use this medication if allergic to tamsulosin.
Proscar (Generic name: Finasteride) is an oral drug that is used to help shrink enlarged prostate. Prostate enlargement, also known as Benign Prostate Hyperplasia (BPH), is non-cancerous but often results to the obstruction of the urine flow from the bladder. Aside from shrinking enlarged prostate, Proscar is also used to treat hair loss problems among males. In fact, Proscar has been approved by the FDA for hair loss treatment. The side effects of taking Proscar include decrease of semen per ejaculation, impotence or decreased in sex drive. On the other hand, no significant drug interactions are reported with this particular drug.
Benign prostatic hyperplasia