Sensum+ Cream Launched to Improve Penile Sensitivity

Innovus Pharma announced the launch of Sensum+, an over-the-counter (OTC) cream to increase penile sensitivity.

Advanced Glycation End Products and Renal Function Loss, What's the Link?

AGEs improve RFL prediction in American-Indians with type 2 diabetes

Reducing Outcomes Beyond Stroke May Be Warranted in A-Fib Patients

Atrial fibrillation is associated with a wider range of conditions than previously believed, according to a review and meta-analysis published online in The BMJ.

FDA: Natural Herb Coffee Found to Contain Undeclared Drug

The Food and Drug Administration (FDA) is warning consumers not to buy or use Kopi Jantan Traditional Natural Herbs Coffee.

Fexapotide vs. Conventional BPH Treatments Evaluated in Crossover Study

Nymox announced positive data from the Phase 3 study of fexapotide for the treatment of benign prostatic hyperplasia (BPH) and localized prostate cancer.

Long-Term OnabotulinumtoxinA Evaluated for Overactive Bladder

OnabotulinumtoxinA treatment is safe and effective for long-term treatment of overactive bladder syndrome, according to a study published in the September issue of The Journal of Urology.

AUA: Updated Guidance on Treating Kidney Stones

The American Urologic Association has issued a new guideline for the surgical management of patients with kidney and/or ureteral stones, containing over 50 statements on best practices.

Study Examines Laxative Efficacy Post-Urogynecologic Surgery

For women undergoing urogynecologic surgery, addition of polyethylene glycol 3350 (PEG3350) to docusate sodium does not reduce the time to first bowel movement, according to a study published in Obstetrics & Gynecology.

Study Finds Vaginal Mesh Complications Tied to Proinflammatory Response

Women with vaginal mesh with complications have a significantly increased proinflammatory response, according to a study published in the American Journal of Obstetrics & Gynecology.

Vasopressin: An Effective First-Line Option for Septic Shock?

In adults with septic shock, early vasopressin use vs. norepinephrine did not improve the number of kidney failure-free days, a study in JAMA concluded.

Cardioprotective Effects of PDE5is Investigated in Men with T2DM

A significant reduction in all-cause mortality risk was seen in men with type 2 diabetes who were taking phosphodiesterase type-5 inhibitors (PDE5is).

Should Functional Impairment in Seniors With CKD Be Routinely Assessed?

Older adults with chronic kidney disease (CKD) have a considerable burden of functional impairment, according to research published online in the Journal of the American Geriatrics Society.

FDA Approves OTC Device to Help with Urinary Incontinence

Analytica announced that the Food and Drug Administration (FDA) has approved PeriCoach at-home pelvic floor trainer device and smartphone app as an over-the-counter (OTC) treatment for mild, moderate, and stress urinary incontinence (UI) and urge incontinence.

Which Drug Combos Up Risk of Acute Kidney Injury?

Researchers conducted a literature review to assess current evidence of drug class combinations and their association with the development of acute kidney injury (AKI).

Melanoma Risk with PDE5 Inhibitors Likely Due to Sun, Not Side Effect

The small apparent increase in risk of melanoma in men prescribed phosphodiesterase type 5 (PDE5) inhibitors may be explained by greater sun exposure, according to new research published online in PLOS Medicine.

FDA Strengthens Renal Injury Warnings for Some Diabetes Meds

The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

Do SSRI/SNRIs Affect Nighttime Urinary Frequency?

Selective serotonin reuptake inhibitors (SSRIs) and selective noradrenaline reuptake inhibitors (SNRIs) do not appear to significantly impact nocturnal urinary frequency, researchers from Albany Medical College, Albany, NY, reported.

Long-Acting Testosterone Improves Sexual Function in Men with T2DM

For males with mild hypogonadism, only scores in sexual desire showed significant improvement

Recombinant Human Alkaline Phosphatase Fast Tracked for AKI

AM-Pharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to recAP (recombinant human Alkaline Phosphatase) for the treatment of acute kidney injury (AKI).

How Does Coffee, Tea Consumption Impact Estimated GFR?

Consuming multiple cups of coffee a day is likely to be safe for the kidneys in the general population, and is associated with an increase in estimated glomerular filtration rate (eGFR), according to findings of a study from the Netherlands.

Herbal Remedies May be "Global Health Hazard," Commentary Suggests

In a commentary published in EMBO reports, study authors present data showing that herbals containing Aristolochia species can cause aristolochic acid nephropathy (AAN).

Triferic Powder Packets Approved for Iron Replacement in Hemodialysis Patients

Rockwell Medical announced that the Food and Drug Administration (FDA) has approved Triferic (ferric pyrophosphate citrate) powder packet for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (CKD).

HPV Vaccine May Not Be as Effective in Kidney Transplant Patients

Administration of the human papillomavirus (HPV) vaccine led to sustained immune response in girls and young women with chronic kidney disease (CKD) and in those on dialysis but led to an inadequate response in those with a kidney transplant.

AKI Incidence Compared in Vancomycin Combo Therapies

No significant difference was seen in the incidence of acute kidney injury (AKI) development or other outcomes between patients who received vancomycin + piperacillin-tazobactam vs. vancomcyin + cefepime.

What Effect Do Statins Have on Kidney Disease Outcomes?

Statin use did not reduce the risk for kidney failure events in adults not receiving dialysis but may modestly reduce proteinuria and rate of estimated GFR (eGFR) decline, a study published in American Journal of Kidney Disease has reported.

You May Be Required to Get a Permission Slip from a Spouse Before Writing This Rx in Kentucky

A newly proposed bill by a Kentucky legislator requires men to get signed consent from their spouses and visit a doctor twice prior to receiving drugs for erectile dysfunction (ED).

Recall: Impurities Detected in Drug Used to Treat CKD Patients

Teva announced a voluntary recall of one lot of Paricalcitol 1mcg capsules, the generic version of AbbVie's Zemplar.

Food Reference App Helps Patients Choose Bladder-Friendly Foods

An app produced by the Interstitial Cystitis Network (ICN) may bring some relief to patients with urinary disorders looking to avoid foods that may provoke the pain and discomfort of their condition.

Higher Rate of Kidney Failure Seen With Two Common Antibiotics

Researchers found a link between increased risk of kidney damage and two common antibiotics, vancomycin and piperacillin-tazobactam.

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.