New Treatment for Enlarged Prostate: FDA Approves New Drug for BPH

Prostate enlargement or Benign Prostate Hyperplasia is a condition common among men as they grow older. The enlarged prostate gland in men causes disturbing urinary symptoms by blocking urine flow. However, there were already existing medications and therapies for treating BPH. Recently, the FDA has given approval for a new treatment for enlarged prostate. Keep reading to learn about all the essential details.

  • Urology

By Ipshita Ghoshal

Updated on 3rd, May'23

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The prostate gland goes through two growth phases during a man's life. First, it grows twice its size during puberty, and then from the age of 25 years, it keeps on growing the whole life gradually. The problem arises when the prostate grows unusually large. 

BPH is benign in nature, i.e., it is not cancerous, but it holds the chance of initiating cancer later on if not treated on time. Not treating BPH on time will cause serious health issues like urinary retention, renal insufficiency, and renal failure or back pain

Photo stethoscope with symptoms words on wooden cude

Some of the common symptoms to identify BPH are:

  • Frequently feeling the urge to pass urine.
  • Passing urine more frequently during the night.
  • Difficulty in passing urine
  • Unable to empty the bladder completely
  • Intermittent or weak urine flow.

Research has shown that almost 25% of men aged 40-49 years have BPH. If we talk about the global scenario, 20% to 62% of men over 50 years are diagnosed with BPH.

In December 2021, the FDA approved the latest treatment for enlarged prostate, Entadfi. It is a combination of two drugs; Finasteride and Tadalafil. The drug was found to be more effective in treating urinary tract symptoms. The drug was made available in the market in early 2022.

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Now it's time to take a closer look at the latest treatment for BPH. 

More details on the latest BPH treatment

On December 13, 2021, the FDA approved a new drug for BPH. Entadfi (finasteride and tadalafil) is an oral capsule with less potential to cause unpleasant sexual side effects. This drug is taken for 26 weeks of BPH treatment. 

Tadalafil is approved for daily consumption to treat erectile dysfunction and BPH. 

Finasteride has been approved. It can help with symptoms, lower the risk of acute urine retention and the requirement for prostate surgery, and stop the growth of BPH.

 Photo on a purple background a stethoscope with wooden list for you text side effects

Are there any side effects of Entadfi?

Entadfi has mild to severe side effects like any other drug. You must know the side effects before taking the new medication for BPH. Read along to learn about it.

The new treatment for BPH has  side effects arising as a result of taking Tadalafil are listed below:

  • Headache
  • Indigestion
  • Back Pain
  • Muscle pain
  • Runny and stuffy nose
  • A longer-lasting erection(Not a usual side effect, but it can be seen in a few men)
  • Not being able to achieve an erection
  • Reduction in sex drive
  • Reduction in volume of ejaculate
  • Pain in breasts
  • Allergic reactions 
  • Depression
  • Rare testicular pain
    If you are facing any side effects mentioned above consult a Urology specialist hospital for better treatment.

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Free photo medicine and glass of water

Can any other drug affect the action of Entadfi?

Before taking Entadfi, it is advisable to consult your doctor.

Entadfi can decrease your blood pressure to an unsafe level if you are taking certain other medications:

  • Avoid taking Entadfi if you take nitrate medications. 
  • If you are taking medicines known as guanylate cyclase stimulators, then you must not take Entadfi.
  • Entadfi is not at all advisable for pregnant women.
  • If you’re taking “popper,” a recreational drug, you must abstain from taking Entadfi.
  • Erectile dysfunction medicines can also have adverse effects if taken along with Entadfi.

Who cannot take Entadfi?

Entadfi can only be consumed only by men.

  • You are not eligible to take Entadfi:
  • If you are a pregnant women
  • If you have allergies like rashes or hives.
  • If you have swelling of lips, tongue, or throat.
  • If you face difficulty in breathing and swallowing.

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Frequently Asked Questions

Is back pain always a symptom of an enlarged prostate?

Can certain medications cause back pain in men with an enlarged prostate?

Can spinal problems cause symptoms similar to an enlarged prostate?

How does an enlarged prostate cause back pain?

Can back pain be a symptom of prostate cancer?

Can an enlarged prostate cause muscle spasms in the back?

Can an enlarged prostate cause referred back pain?

Can an enlarged prostate cause back pain during ejaculation?

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Question and Answers

Hi pain in kidneys shooting and feel sick

Female | 21

If you're experiencing shooting pain in your kidneys and feeling sick, consult a urologist in your locality. Kidney pain can be caused by various factors, including kidney infections, kidney stones, or other kidney related conditions. And feeling sick could be due to an underlying issue. 

Answered on 27th Sept'23

Dr. Neeta Verma

Dr. Neeta Verma

Firstly, approximately 20 years ago, I experienced a significant shoulder impact while playing football, resulting in a sprain that extends from my neck to the back of my shoulder. Whenever I engage in physical activity, particularly on the injured right shoulder side, I feel a burning sensation accompanied by heat. Additionally, I've noticed that my right hip appears elevated since the injury. In a previous scan, I discovered a left-sided disc prolapse. Moreover, I occasionally experience sprains in the middle of my back. I have not been taking any medications for this issue as previous doctors have been unable to identify the problem. I am concerned about the long-term implications and would greatly appreciate your expertise in evaluating and providing guidance on the appropriate course of action. Are there any specific tests or examinations that you recommend to better understand the underlying causes and potential treatment options for my shoulder, hip, and back issues? Furthermore, I recently discovered that I have kidney stones in both of my kidneys. I do not have diabetes or high blood pressure, and I am not diagnosed with arthritis. Additionally, I have been informed that I have elevated uric acid levels. Considering these multiple health concerns, I am wondering if blood tests or any other diagnostic tests would be beneficial in identifying any potential connections between these issues and guiding the most appropriate treatment plan.

Male | 44

To address your musculoskeletal concerns consult an orthopedic specialist. They would recommend imaging studies, physical therapy, and medications as needed. For your kidney stones and elevated uric acid, seek guidance from a urologist nearest to you or a nephrologist who can perform diagnostic tests. I suggest to follow certain dietary changes, and monitor your kidney health. Open communication with your specialists for a tailored treatment plan for your multiple health concerns.

Answered on 27th Sept'23

Dr. Neeta Verma

Dr. Neeta Verma

Answered on 27th Sept'23

Dr. Neeta Verma

Dr. Neeta Verma

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