FDA No comment as Pharmaceutical Industry is rocked by accusations of ineffective and overpriced Drugs.
WARNING: This may be disturbing reading for older men or any man who has undergone medical treatment for BPH or Prostate related issues.
A private meta-study being released in July has already begun to scare the pharmaceutical industry. The Study Focuses on 11 high impact large studies that examined the side effects and effectiveness of commonly prescribed Prostate Drugs. The Study Concluded that “Alpha Blockers such as Tamsulosin have no long term impact on PSA levels or BPH. They act solely on the symptoms with varying degrees of success”. It also pointed out that “While most of the side effects of the commonly prescribed drugs are not life threatening, there are some that raise serious concerns about the safety and efficacy of using these drugs to treat BPH”. While the full study is not yet released, some parts of it have been seen, leaked and discussed. Highlights from each of the eleven studies that make up the meta-study are below. We have also included a handy Glossary of terms just below, there are also links throughout the article for men interested in more information on Prostate medications and safe and effective treatments for BPH.
Glossary Of Terms
Drug Related Problems (DRP) = Side effects as a result of the medication
Lower Urinary Tract Symptoms (LUTS) = Symptoms such as Storage or retention of urine, difficulty starting or finishing, emptying the bladder or waking often to urinate.
Benign Prostatic Hyperplasia (BPH) = The medical term for an enlarged or inflamed Prostate. A common prostate condition that the majority of older men suffer from.
Alpha Blockers (α-Blocker/AB) = A commonly prescribed family of drugs, notably including Flomax (Tamsulosin).
5-Alpha-reductase Inhibitor (5-ARIs) = A class of drugs with antiandrogen effects, used primarily in the treatment of BPH . Notably including Finasteride and Dutasteride
Effects of α-Blocker Therapy on Active Duty Military and Military Retirees for Benign Prostatic Hypertrophy on Diabetic Complications,MAJ Sky D. Graybill , MC USA*; COL Robert A. Vigersky , MC USA MILMED-D-14-00392
This was a study 330 men who were taking Alpha Blockers (AB+) compared against a control of 770 men who were not taking Alpha Blockers (AB-) for similar conditions.
- Men who were taking Alpha Blockers had evidence of more cardiovascular and renal disease diagnoses. Also more of them had hyperlipidemia (HLD) and peripheral vascular disease (PVD).
Medication Safety and Reliability. FDA warns 5-ARIs may increase the risk of high-grade prostate cancer,Formulary; Aug2011, Vol. 46 Issue 8, p313
These 2 trials randomly assigned more than 27,000 men over the age of 50 years to receive a 5-ARI (5-alpha-reductase inhibitor) or a placebo. Trial participants were followed for 4-7 years. The risk of high-grade prostate cancer was increased with 5-ARI such as Finasteride or Dutasteride use in both trials
- Patients who were treated with Finasteride or Dutasteride had an increased risk of developing high-grade Prostate Cancer.
- New FDA warnings are now included in revised prescribing information
- Between 2002 and 2009 nearly 3 million men between ages 50-79 years are thought to have been prescribed a 5-ARI (5-alpha-reductase inhibitor).
Adverse Side Effects of 5α-Reductase Inhibitors Therapy: Persistent Diminished Libido and Erectile Dysfunction and Depression in a Subset of Patients,Traish, M. et al. (2011), Journal of Sexual Medicine, 8: 872–884
The efficacy of these drugs, (Finasteride or Dutasteride/ Proscar or Avodart) has been called into question alongside whether or not they can be safely used to treat BPH or prostate disease. Many doctors and medical practitioners are calling for even greater warnings in the face of new emerging scientific evidence from preclinical and clinical studies. The available data demonstrate that such drugs do pose serious adverse effects, especially in a subset of men who may have the predisposition to be affected severely.
- The study uncovered 3 new, previously unknown, side effects of: Sexual Dysfunction, High Gleason Grade Prostate Cancer and Depression.
- There is now a substantial body of evidence pointing to serious side effects of undertaking 5α-RI therapy. These include loss of or reduced libido, erectile dysfunction, orgasmic and ejaculatory dysfunction, development of high grade Prostate Cancer tumors, potential negative cardiovascular events and depression.
- The side effects are very harmful and in the case of younger men there is some evidence that they may be persistent or irreversible.
Progression of Lower Urinary Tract Symptoms After Discontinuation of 1 Medication From 2-Year Combined Alpha-blocker and 5-Alpha–reductase Inhibitor Therapy for Benign Prostatic Hyperplasia in Men – A Randomized Multicenter Study, Lin, Victor Chia-Hsiang et al., Urology , Volume 83 , Issue 2 , 416 - 421
This was a randomized, multi-cancer study that focused on the progression of Lower Urinary Tract Symptoms (LUTS) 1 year after men stopped taking Alpha Blockers.
There have been limited data showing how long a man should take combination therapy for BPH/LUTS and whether the LUTS will relapse or if surgery becomes necessary after discontinuing medications.
- The study confirmed that after combination therapy, discontinuation of the medications induced progression of LUTS or uroflow parameters in most patients.
- Discontinuing a medication from combination therapy was associated with BPH progression in either group that needs to resume combined medication or surgical intervention.
- The conclusion is that the medication had not “cured” the disease, but was suppressing or hiding symptoms.
Reasons for Prescription Change of α1-Blockers in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia, Kim, Tae Nam et al. Urology , Volume 84 , Issue 2 , 427 - 432
This study investigated the reasons why patients changed their prescriptions when they had LUTS suggestive of BPH. While a greater number of men may have requested changes to their prescriptions, just under a quarter (21.7%) where successful in convincing their doctors to make the changes. The large majority of the reasons given for changing their prescription was lack of efficacy and adverse side effects. The breakdown of prescription drugs being taken by the patients were: 182 (doxazosin), 486 (alfuzosin), 2149 (tamsulosin), and 383 (silodosin).
Trends in adverse events of benign prostatic hyperplasia (BPH) in the USA, 1998 to 2008.Stroup, S. P., Palazzi-Churas, K., Kopp, R. P. and Parsons, J. K. (2012), BJU International, 109: 84–87.
This was a decade long trend analysis undertaken in the USA from 1998 to 2008. The main objective was to determine if the adverse events of BPH have declined in tandem with increased use of oral medication based therapies.
- The study revealed that BPH-associated acute renal failure, urinary retention, bladder stones, and UTI among hospitalized patients in the USA have not declined in an era of widespread use of medical therapies.
- These finding are surprising in that it is reasonable to hypothesize that the frequency of severe AEs related to BPH would have decreased during the study period.
- The numbers suggest that taking Prostate related pharmaceuticals do not lessen your changes of suffering an adverse effect of BPH.
Drug-Related Problems in Patients with Benign Prostatic Hyperplasia: A Cross Sectional Retrospective Study.Zaman Huri H, Hui Xin C, Sulaiman CZ (2014)
This was a cross sectional retrospective study that examined the chances of patients developing drug related problems (DRP) as a result of their Prostate medications.
- DRP is a term describing “an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes”.
- The majority of Older men suffer significant side effects as a result of their BPH medications.
- Many men with BPH are prescribed multiple medications leading to increased risks of drug-drug interactions.
- Undetected DRPs may result in drug-related morbidity and, if unattended or untreated, may lead to drug-related mortality.
- 76.1% of hospital admissions of the BPH patients in the study included at least one DRP.
- Of all the BPH medications, α-blockers were the most frequently prescribed medication among the study population.
Dutasteride on Benign Prostatic Hyperplasia: A Meta-analysis on Randomized Clinical Trials in 6460 Patients, Xiao-Jun Wu et al, The Journal of Urology Volume 83, Issue 3, March 2014, Pages 539–543
This was a meta-analysis on 4 large clinical trials and was concerned with the clinical effectiveness of Dutasteride in the treatment of BPH.
- This meta-analysis confirmed that dutasteride might cause significantly more events of sexual dysfunction than placebo.
- Impotence, decrease libido, gynecomastia, and ejaculation disorder are the most common side effects and the major reason why patients give up on the medication.
Change in Sexual Function in Men with Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia Associated with Long-Term Treatment with Doxazosin, Finasteride and Combined Therapy.Chyng-Wen Fwu et al, The Journal of Urology, Volume 191, Issue 6, June 2014, Pages 1828–1834
This study looked at the sexual side effects of common percription Prostate medications.
- Men taking the Pharmaceutical medications suffered a greater rate of decreased sexual functioning than men taking the placebo.
- Men assigned to Finasteride and combined therapy also experienced slight worsening of ejaculatory function compared with men on placebo.
- Men assigned to combined therapy also experienced worsening in erectile function and other sexual problems.
Antimuscarinics and α-blockers or α-blockers Monotherapy on Lower Urinary Tract Symptoms – A Meta-analysis,Nan Hao et al,Hong Li, The Journal of Urology Volume 83, Issue 3, March 2014, Pages 556–562
This was a meta-analysis done to assess the clinical efficiency and safety of combination pharmacotherapy of antimuscarinics and alpha blockers such as Tamsulosin versus alpha blockers monotherapy on patients with moderate to severe LUTS.
Patients with LUTS experienced decrements in both quality of life and health status as symptomatic severity increased, with most men experiencing problems with mobility, self-care, activities of daily living, pain or discomfort, and anxiety or depression, it was unclear how many of these were DRP or symptoms of the condition.
Many patients might not respond adequately to α-blocker monotherapy, particularly patients with predominant storage symptoms.
Association of Sexual Dysfunction With Lower Urinary Tract Symptoms of BPH and BPH Medical Therapies: Results From the BPH Registry,Raymond C. Rosen et al,Urology Volume 73, Issue 3, March 2009, Pages 562–566
- ED and EjD are also side effects of some medical therapies for LUTS suggestive of BPH.
- The results of this study support previous studies of LUTS as an independent risk factor for ED and EjD.
- The results of a recent survey of US urologists and primary care physicians suggested that physicians are underestimating the prevalence of sexual dysfunction in patients with LUTS/BPH.
For More information about what Prostate Medications are safe and effective we recommend you> watch this guide to Prostate Treatments by bestselling author and metabolic health expert Ben Ong.
Lin, Victor Chia-Hsiang et al., Urology , Volume 83 , Issue 2 , 416 - 421
. Zaman Huri H, Hui Xin C, Sulaiman CZ (2014)
Stroup, S. P., Palazzi-Churas, K., Kopp, R. P. and Parsons, J. K. (2012), BJU International, 109: 84–87.
. Traish, M. et al. (2011), Journal of Sexual Medicine, 8: 872–884
MAJ Sky D. Graybill , MC USA*; COL Robert A. Vigersky , MC USA MILMED-D-14-00392
Raymond C. Rosen et al, Urology Volume 73, Issue 3, March 2009, Pages 562–566
Chyng-Wen Fwu et al, The Journal of Urology, Volume 191, Issue 6, June 2014, Pages 1828–1834
Nan Hao et al, Hong Li, The Journal of Urology Volume 83, Issue 3, March 2014, Pages 556–562
Xiao-Jun Wu et al, The Journal of Urology Volume 83, Issue 3, March 2014, Pages 539–543
Kim, Tae Nam et al. Urology , Volume 84 , Issue 2 , 427 - 432
Formulary; Aug2011, Vol. 46 Issue 8, p313