Unapproved Antidepressant Found in Dietary Supplement Capsules

National Video Supply announced a voluntary recall of all lots of RHINO 7 3000 Platinum Capsules after an analysis by the Food and Drug Administration (FDA) found these products contain two undeclared ingredients.

Overactive Bladder Drug to Be Discontinued

The decision to discontinue the product is business-related and not due to product safety or efficacy.

Botox for OAB: New Long-Term Results on Safety, Efficacy

llergan announced results from an extension study of two Phase 3 trials on the long-term safety and efficacy of Botox (onabotulinumtoxinA) in female patients with overactive bladder (OAB) with symptoms of urge urinary incontinence.

Calcium Supplements May Worsen Kidney Stones

Although greater consumption of dietary calcium may lower the risk of kidney stone recurrence, research presented at the American Society of Nephrology's (ASN) Kidney Week 2015 in San Diego, suggests that calcium supplementation could actually increase this risk.

First Data on Long-Term Testosterone Tx, Risk of High Grade Prostate Cancer

The first population-based study on high grade prostate cancer and long-term exposure to testosterone therapy reported no increased risk with exposure to this treatment, nor a dose-dependent relationship between prostate cancer risk and testosterone therapy.

For Genitourinary Menopausal Symptoms, Method of Tx Matters for Adherence

Research presented at the 2015 Annual Meeting of The North American Menopause Society (NAMS) supports previous findings that use of local estrogens for genitourinary symptoms of menopause (vaginal dryness, painful intercourse, and urinary tract infections) are underutilized, but the study also reports that method of local treatment can impact treatment duration and adherence to therapeutic guidelines.

New Contraindication for PDE-5 Inhibitors

The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for phosphodiesterase 5 (PDE-5) inhibitors regarding a new contraindication with guanylate cyclase stimulators, such as riociguat.

Sodium, Potassium Intake May Affect CKD Progression

Too much sodium and potassium intake may accelerate the progression of kidney disease, a recently published study has shown.

Over 25 Weight Loss, Sex Enhancement Supplements Withdrawn

The One Minute Miracle, Inc. announced a voluntary recall of all lots of Miracle Diet 30 and Miracle Rock 48 capsules.

Biologic Tx BLA Accepted for Bladder Cancer

The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.

Sexual Side Effects of BPH Drugs May Last in Tx

A review in the journal Endocrine Reviews and Metabolic Disorders reports that greater education and awareness of the potential risks associated with two treatments for benign prostate hyperplasia (BPH) is needed among both patients and clinicians, along with additional research exploring these reported adverse effects.

Myrbetriq Gains New Contraindication, Warning

The Food and Drug Administration (FDA) has approved changes to the Myrbetriq (mirabegron; Astellas Pharma) label to include a new contraindication and a new update to the Warnings and Precautions section.

Tainted Weight Loss, Men's Vitality Supplements Recalled

Blue Square Market, Inc. announced voluntary recalls of Kaboom Action Strips and LiDa DaiDaiHua due to the presence of undeclared active ingredients.

Tamsulosin May Help with Some, But Not All, Kidney Stones

Tamsulosin was found to improve passage of larger, but not smaller, kidney stones compared to placebo, according to a study in the Annals of Emergency Medicine.

Added Phosphates in Food Could Harm the Kidneys

Phosphates artificially added to foods like dairy and cereal products have been associated with sharp increases in blood phosphorous levels that could be harmful to the kidneys, particularly for patients with existing reduced kidney function.

Novel Oral Susp Found Effective in Treating Hyperkalemia

Patiromer oral suspension, an investigational drug, was found to reduce elevated potassium levels in patients with chronic diabetic kidney disease in a study published in JAMA.

Testosterone Tx for Ejaculatory Disorders: First Clinical Trial Results

Testosterone replacement therapy did not improve sexual function males with ejaculatory disorders and low testosterone levels, data from a new study showed.

New Pelvic Muscle Training Device Available for Urinary Incontinence

The PeriCoach System is now available to strength and tone pelvic muscles in women with urinary incontinence following its approval in March 2015.

New Insight on ED Drugs-Melanoma Risk Link

Patients taking medications for erectile dysfunction may have an increased risk of melanoma, but these drugs are not a cause of melanoma, researchers concluded.

Female Sexual Dysfunction May Be Linked to Resting Heart Rate

A women's low resting heart rate variability may be associated with sexual dysfunction, a study published in Applied Psychophysiology and Biofeedback has shown.

Significant ED Worsening Seen With BPH Drug

Men treated for benign prostatic hyperplasia (BPH) with the type II 5 alpha-reductase inhibitor finasteride could be significantly more likely to experience erectile dysfunction (ED) compared to those taking the alpha-1A blocker tamsulosin.

AUA Discusses Antimicrobials, PSA Testing in New Choosing Wisely Recommendations

The American Urological Association (AUA) has issued a new list of recommendations as part of the Choosing Wisely campaign.

Why Children With CKD May Need More Vitamin D

Vitamin D supplementation could help children with mild-to-moderate chronic kidney disease (CKD) in reducing the risk of renal failure progression, according to a study published in the Journal of the American Society of Nephrology (JASN).

Novel Agent AMG 416 Effective in Secondary Hyperparathyroidism Trials

Amgen announced pooled data from two Phase 3 trials evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.

Treating Overactive Bladder May Reduce Fall Risk in Elderly

A new study has shown that treatment for overactive bladder (OAB) may lead to less falls among older adults.

Solifenacin + Mirabegron Shows Superiority in Incontinent Overactive Bladder Trial

Astellas Pharma announced results from the Phase 3b BESIDE trial with solifenacin (SOLI) with mirabegron (MIRA) as an add-on therapy in incontinent overactive bladder (OAB) patients.

Xiaflex Label Updated With Contracture Recurrence Data

Endo announced that the Food and Drug Administration (FDA) has approved a label update for Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord.

Dexamethasone May Protect Against Severe AKI Post-Cardiac Surgery

Dexamethasone can help prevent serious kidney complications that can arise following heart surgery, a new study has shown.

FDA: Beware of Hidden Ingredients in Multiple Supplements

The Food and Drug Administration (FDA) is warning consumers not to use or buy the following tainted supplements marketed for weight loss and sexual enhancement:

High-Dose Creams More Effective for Genital Warts, Reports Study

A high-dose treatment of sodium nitrite and citric acid creams applied twice daily was more effective than placebo for treating anogenital warts, according to a new study in JAMA Dermatology.

CRLX101 Fast Tracked for Metastatic Renal Cell Carcinoma

The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.

New Warning From FDA on Unapproved Drugs in Sex Enhancement Supplement

The Food and Drug Administration (FDA) is warning consumers to not buy or use Extreme Diamond 3000, a product promoted and sold for sexual enhancement.

Counterfeit Botox Discovered in the U.S.

The FDA is alerting healthcare providers and the public that counterfeit Botox (onabotulinumtoxin A; Allergan) has been found in the United States and may have been distributed to doctors' offices and clinics.

Progression-Free Survival With Encalutamide for Prostate Cancer: New Trial Results

Astellas Pharma and Medivation announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in men with non-metastatic or metastatic castration-resistant prostate cancer.

Zytiga Label to Include Overall Survival Data

The Food and Drug Administration (FDA) has approved a label update for Zytiga (abiraterone acetate; Janssen Biotech) to include statistically significant results in combination with prednisone for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC).

Multiple Undeclared Drugs Found in Sex Enhancement Pills

The Food and Drug Administration (FDA) is warning consumers to not buy or use Diablos Eca Fire Caps, Stiff Nights, La Pepa Negra, and Herb Viagra, which are marketed for sexual enhancement.

More HPV Vaccinations for Boys: Greater Protection, Same Cost

Encouraging more boys to be vaccinated against human papillomavirus (HPV) may protect more people for the same cost, a recent study reports.

NSAID + PPI May Slash Bladder Cancer Risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) have shown promise in preventing certain types of cancers, but their use can also carry an increased risk of gastric ulcers and potentially life-threatening bleeds. However, a new study suggests that combining a proton pump inhibitor with an NSAID could reduce the risk of bladder cancer by as much as 75 percent.

Male Fertility Linked to Hypertension, Taking Multiple Meds

Hypertension, taking multiple medications and working a physically demanding job may impact male fertility, according to researchers at the National Institutes of Health (NIH) and Stanford University

First Device for Dialysis-Related Amyloidosis Approved

The Food and Drug Administration (FDA) has authorized use of Lixelle Beta 2-microglobulin Apheresis Column (Kaneka Pharma America), the first device to treat dialysis-related amyloidosis (DRA).

Additional Sex Enhancement Pills Found to Contain Undeclared ED Drug

The Food and Drug Administration (FDA) is warning consumers to not buy or use Black Ant King, Black Mamba Premium, African Superman, and Bigger Longer More Time More Sperms (sic), which are all marketed for sexual enhancement.

CVD Screening May Benefit Men with ED

Men presenting with erectile dysfunction (ED) may benefit from screening for cardiovascular disease (CVD), a new cost-analysis study shows.

FDA: Testosterone Replacement Tx Review Prompts New Warnings, Updated Labeling

The Food and Drug Administration (FDA) announced that prescription testosterone product labels must be changed to clarify the approved use of these medications and information on the possible increased risk of heart attacks and strokes in patients taking testosterone must also be added.

What Will CKD Prevalence be in 2030? New Prediction for Adults Over 30

A new report predicts that the prevalence of chronic kidney disease (CKD) in adults aged 30 and over will rise from the current rate of 13.2 percent to 16.7 percent by 2030.

Even More Tainted Sex Enhancement Pills Discovered in International Shipments

The Food and Drug Administration (FDA) is warning consumers to not use or buy SEx Men, Super Hard, Santi Scalper, Vigra, Plant Vigra, Vigour 300, MME MAXMAN, Hard Wang, FX3000 after they were found to contain hidden drug ingredients.

Overactive Bladder Drug May be Beneficial in MS

Researchers from the University of Buffalo have found a way to improve remyelination for myelin-based diseases like multiple sclerosis (MS).

Some Frequently Ordered Tests May Not Be Necessary to Diagnose CKD

Many of the tests performed to screen for chronic kidney disease (CKD) may offer little clinical benefit on diagnosis and management, according to a research letter.

FDA Uncovers Six Tainted Sex Enhancement Pills

The Food and Drug Administration (FDA) has warned against the use of Libigrow XXX Treme, Night Man, Black King Kong, 72HP, Tibet Babao, and Germany Niubian supplements promoted for sexual enhancement.

FDA: Vogelxo Therapeutically Equivalent to Testim

Upsher-Smith announced that Vogelxo (testosterone) gel 1% has received an AB (therapeutic equivalent) rating from the Food and Drug Administration (FDA).

New Triferic Replaces Iron Losses, Maintains Hemoglobin in Hemodialysis Patients

Rockwell Medical announced that the FDA has approved Triferic (soluble ferric pyrophosphate) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease.

Counterfeit ED Drug Found in U.S. Mail

The Food and Drug Administration (FDA) is warning healthcare professionals and consumers that counterfeit versions of Cialis (tadalafil; Eli Lilly) 20mg tablets were discovered in the mail in transit to a U.S. consumer.

Supplement Found to Contain Undeclared Sildenafil

The Food and Drug Administration (FDA) is advising consumers to not buy or use Happy Passengers, a product promoted and sold for sexual enhancement.

Phoxillum Approved for Electrolyte Imbalances in CRRT

Baxter announced that the Food and Drug Administration (FDA) has approved Phoxillum Renal Replacement Solutions (BK4/2.5 and B2K4/0) for use in continuous renal replacement therapy (CRRT) to replace plasma volume removed by ultrafiltration, correct electrolyte and acid-base imbalances, and for use in drug poisoning when CRRT is used to remove dialyzable substances.

Overactive Bladder Drug May Possibly Promote Weight Loss

Brown adipose tissue was successfully activated and energy expenditure increased in 12 lean adult men treated with mirabegron in a new study.

Sparsentan Gains Orphan Drug Designation for Rare Nephropathy

The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

Chlamydia, Gonorrhea Cases Down But Syphilis Rates Up

The Centers for Disease Control and Prevention (CDC) has released its annual fact sheet of the three reported sexually transmitted diseases (STDs): chlamydia, gonorrhea, and syphilis.

FDA Expands Syphilis Screening Test Access

The Food and Drug Administration (FDA) has granted the first-ever waiver under specific laboratory regulation for Syphilis Health Check test to be used in expanded healthcare settings.

New Dx Test to Detect AKI Risk Launched

Ortho-Clinical Diagnostics announced the launch of NephroCheck Test System to help identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of assessment.

FDA Approves Gardasil 9 Vaccine

The Food and Drug Administration (FDA) has approved Gardasil 9 (9-valent human papillomavirus types, recombinant; Merck) vaccine for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV).

Apex Device Now Approved for OTC Use

InControl Medical announced it has received clearance from the Food and Drug Administration (FDA) to market their Apex Device over-the-counter (OTC).

Hospital Error Rates, Related Health Costs on the Decline

Hospital-acquired conditions (HACs) experienced a 17% decline from 2010-2013 and a 9% reduction from 2012-2013, according to figures released by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS).

No Added Benefit with Two-Drug Tx in Polycystic Kidney Disease

In patients with autosomal dominant polycystic kidney disease (ADPKD), the use of two drugs was not more effective than using a single drug in slowing disease progression, according to the results of two studies funded by the National Institutes of Health (NIH).

Sunscreen Chemicals May Lower Fertility in Men

Certain chemicals used in sunscreens and other personal care products have been linked to reduced fecundity in men, according to a study appearing in the American Journal of Epidemiology.

Tivantinib Improves Progression-Free Survival in Prostate Cancer Trial

ArQule announced positive results from a Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer.

Emergency Docs Issue Additional Choosing Wisely Recommendations

The American College of Emergency Physicians (ACEP) has released a second list of their Choosing Wisely recommendations.

Replaceable Urinary Prosthesis For Women Cleared by FDA

The Food and Drug Administration (FDA) has granted marketing clearance for the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).

Efficacy of Oral Testosterone in Hypogonadal Men Demonstrated in Study

Lipocine announced top-line results from its Phase 3 SOAR clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.

FDA Approves Stendra's Rapid Onset of Action

Vivus and Auxilium announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil) to be taken ~15 minutes before sexual activity in the treatment of erectile dysfunction.

Xtandi Approved for Metastatic Castration-Resistant Prostate Cancer

Astellas and Medivation announced that the Food and Drug Administration has approved a new indication for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

First Male Contraceptive Injection to Undergo Testing in 2015

Vasalgel, the first male contraceptive injection, is anticipated to enter its first clinical trial beginning in 2015, according to the Parsemus Foundation.

First-of-Kind Kidney Injury Risk Test Gets FDA Nod

The Food and Drug Administration (FDA) announced that it has allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to assist in determining if some critically ill hospitalized patients are at risk of developing moderate-to-severe acute kidney injury (AKI) in the 12 hours post-test.

Steel, Fiber, PVC ID'd in Dianeal Dialysis Solution

Baxter announced a voluntary recall of 2 lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II).

Two Hidden Ingredients Found in Sex Enhancement Supplements

The Food and Drug Administration (FDA) is advising consumers to not buy or use Arize and Herbal Vigor Quick Fix, products marketed for sexual enhancement.

New Recommendations on Prostate Cx Active Surveillance

A multi-specialty team comprised of pathologists, radiation oncologist, surgeons, and urologists published their recommendations for determining prostate cancer active surveillance.

Growing Uncertainty in BP Treatment Targets

A new study has found that blood pressure (BP) below and above the current Eighth Joint National Committee (JNC 8) recommended targets is linked to an increased risk of renal disease and mortality.

Tainted Sexual Supplement Contains Hidden Ingredient

The FDA is warning consumers not to purchase or use O.M.G., a product marketed for sexual enhancement.

RG-102 Desginated Orphan Drug for Alport Syndrome

The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.

Antiretroviral Drugs Recommended for All MSM, Says WHO

For the first time, the WHO is strongly recommending that men who have sex with men (MSM) consider pre-exposure prophylaxis for the prevention of HIV infection in addition to the use of condoms.

How Do Anticoagulants Affect Men with Advanced Prostate Cancer?

Use of low-molecular-weight heparin decreased the risk of death by 52%.

FDA: New Warning for Testosterone Products

The FDA announced that it is now requiring a general warning in the drug labeling of all approved testosterone products regarding the risk of venous blood clots unrelated to polycythemia.

FDA: Hidden Ingredient Found in Sexual Enhancement Supplement

The FDA is advising consumers to not purchase or use Gold Vigra, a product marketed and sold for sexual enhancement.

Brintellix Effective in Treatment-Emergent Sexual Dysfunction

Takeda and Lundbeck announced the results from a new head-to-head study of Brintellix (vortioxetine) compared to escitalopram in patients with well treated MDD experiencing treatment-emergent sexual dysfunction (TESD).

Erectile Dysfunction Often Present in Men with Gout

Erectile dysfunction (ED) is present and frequently severe in most men with gout, reports research presented at the European League Against Rheumatism Annual Congress (EULAR 2014).

Women Less Likely Than Men to Get Urologist Referral for Hematuria

Women with hematuria were less than half as likely as men with the same issue to be referred to a urologist for further tests, according to a new study.

Undeclared Sildenafil Found in Sexual Enhancement Pills

The FDA is warning consumers to not buy or use Zhen Gong Fu, a product promoted for sexual enhancement.

FDA: Multiple Hidden Ingredients in Sexual Enhancement Supplements

The FDA is warning consumers that several products promoted and sold for sexual enhancement have been found to contain undeclared ingredients and should not be purchased or used.

First Blood Test ID's Chronic Kidney Disease Cause

The FDA has allowed marketing of the EUROIMMUN Anti- PLA2R IFA blood test, the first non-invasive test to help determine if membranous glomerulonephritis (MGN) is autoimmune or if it is due to another cause (eg, infection).

Sanofi, Lilly Pursue OTC ED Drug Approval

Sanofi and Eli Lilly and Company have announced an agreement to pursue FDA approval of Cialis (tadalafil; Eli Lilly and Company) as an over-the-counter treatment for erectile dysfunction (ED).

Non-Surgical Option for Male Urinary, Fecal Incontinence

InControl Medical announced that the FDA has cleared InToneMV, a non-surgical, implant-free treatment for male patients with urinary or fecal incontinence.

Over Two-Thirds of U.S. Infected with HPV

A new study has found that 69% percent of healthy American adults are infected with one or more of 109 strains of the human papillomavirus (HPV).

Improved Penile Curvature Deformity with Xiaflex

Auxilium Pharmaceuticals announced new data from its Phase 3 IMPRESS trials that evaluated Xiaflex for the treatment of Peyronie's disease at the 2014 Annual Meeting of the AUA.

Sexual Adverse Effects of Urology Drugs Studied

Data from 2 studies evaluating sexual function in men with lower urinary tract symptoms as well as post bilateral nerve-sparing radical prostatectomy was presented at the 2014 Annual Scientific Meeting of the AUA.

ED Drug Found in Sexual Enhancement Supplement

The FDA is advising consumers not to purchase or use MV5 Days, a product marketed for sexual enhancement.

Investigational Drug May Improve Vascular Access in Hemodialysis

Proteon Therapeutics announced results from a Phase 2 clinical trial of PRT-201 to use to prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease (CKD).

Decipher Test Impacts Post-Op Tx Choice for Prostate Cancer

GenomeDx Biosciences announced data from two studies showing that Decipher Prostate Cancer Classifier significantly altered treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery.

FDA Accepts Xtandi sNDA for Filing

The FDA has accepted for filing a sNDA to extend the indication for Xtandi (enzalutamide; Astellas Pharma and Medivation) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.

Sotatercept Effective at Increasing Hemoglobin in Trial

Acceleron and Celgene announced interim data from the Phase 2a study of sotatercept (ACE-011), demonstrating dose dependent increases in hemoglobin in patients with end stage renal disease (ESRD) on hemodialysis.

Non-Invasive Blood Test to Detect Prostate Cancer

Beckman Coulter Diagnostics announced the launch of Prostate Health Index (phi), a non-invasive blood test for detecting prostate cancer.

Sexual Dysfunction in Lung Cancer Patients: A Need for Awareness

Many lung cancer patients experience difficulties with sexual expression and intimacy, a topic that has long been ignored by doctors and researchers.

H.P. Acthar Gel Evaluated in Nephrotic Syndrome Study

Questcor Pharmaceuticals announced results from an investigator-initiated clinical study evaluating the dosing and effectiveness of H.P. Acthar Gel (repository corticotrophin injection) in 20 patients with nephrotic syndrome due to idiopathic membranous nephropathy (iMN).

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