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).

Hidden Ingredient Discovered in Sexual Enhancement Supplement

The FDA has warned consumers that the sexual enhancement supplement S.W.A.G. contains an undisclosed ingredient and should not be purchased or used.

Nova Dietary Supplements Recalled

Nova Products announced a voluntary recall of African Black Ant, Black Ant, XZen Gold, ZXen Platinum, XZen 1200, XZone Gold, and XZone 1200, products marketed as dietary supplements for sexual enhancement.

Can Stem Cells Help Treat Bladder Issues?

Researchers have coaxed human stem cells into becoming bladder cells that could aid in repairing defective or diseased bladders.

PSA Screening Decreased Since USPSTF Recommendations

Prostate-specific antigen screening has decreased since publication of the U.S. Preventive Services Task Force Recommendations against screening

Resolved Childhood Glomerular Disease Linked to HTN Risk

Resolved childhood glomerular disease is associated with increased subsequent risk of hypertension.

For Prostate Cancer, SBRT Less Costly, More Toxic Than IMRT

For patients with prostate cancer, stereotactic body radiation therapy is less expensive than intensity-modulated radiation therapy, but is associated with more genitourinary toxicity.

Transvaginal Approaches for Vaginal Prolapse

For women undergoing surgery for vaginal prolapse and stress urinary incontinence, outcomes for two common transvaginal approaches are comparable, and perioperative behavioral therapy with pelvic floor muscle training does not improve surgical outcomes

Have Pediatric Kidney Transplant Outcomes Improved?

Over the last 25 years, pediatric kidney transplantation outcomes have improved in the United States.

Hidden Ingredient Found in Sexual Enhancement Supplement

The FDA has warned consumers that the sexual enhancement supplement Weekend Warrior contains an undisclosed ingredient and should not be purchased or used.

Baxter Recalls Peritoneal Dialysis Solution

Baxter announced a voluntary recall of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II).

Pregnancy Timing Affected by Male Phthalate Levels

High concentrations of three common forms of phthalates in men have been shown to impact fertility in couples trying to conceive.

Study Comparing IV Iron Drugs Shows Similar Efficacy in Patients with CKD

Ferumoxytol and iron sucrose have comparable safety in the treatment of anemia in patients with CKD.

Warfarin Linked to Lower Cardiac Risk in CKD With A-Fib

For patients with established cardiovascular disease and atrial fibrillation, warfarin treatment correlates with a lower risk of a composite of death, myocardial infarction (MI), and ischemic stroke, with no increased risk of bleeding.

DASH Diet May Lower Risk of Recurrent Kidney Stones

The DASH diet may be an effective alternative to the low-oxalate diet for reducing risk of kidney stone recurrence.

Thermal Receipt Handling Impacts Urinary BPA Concentration

Thermal receipt handling is associated with increased urinary concentrations of bisphenol A (BPA).

Repeat Biopsies Up Infection Risk in Prostate Cancer Patients

For men with prostate cancer who are under active surveillance, repeated biopsies are associated with increased risk of infectious complications.

FDA Accepts sBLA for Xiaflex for Concurrent Treatment of Multiple Palpable Cords

The FDA has accepted Auxilium's supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.

Intensive Dialysis Improves Pregnancy Outcomes

For women with end-stage renal disease (ESRD), intensive hemodialysis is associated with improved pregnancy outcomes.

Tamoxifen Found in Samples of Dietary Supplement

Tamoxifen that has been identified in samples of the dietary supplement Esto Suppress.

Bayer HealthCare Initiates Colorectal Cancer Trial with Stivarga

Bayer HealthCare announced that it has begun enrolling patients into the Phase 3 COAST trial studying Stivarga (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases.

Androgen Deprivation Therapy Can Take Emotional Toll

Changes in mental and emotional well-being occur in prostate cancer patients on androgen deprivation therapy (ADT).

Positive Results for Prostate Cancer Treatment with Xtandi

Medivation and Astellas Pharma announced results from their Phase 3 PREVAIL trial of Xtandi (enzalutamide) in patients with chemotherapy-naive metastatic prostate cancer who have failed androgen deprivation therapy and have few or no symptoms.

Sexual Enhancement Supplements Tainted, Says FDA

The FDA is warning consumers that several sexual enhancement supplements have been found to contain hidden ingredients, and that these products should not be purchased or used.

Kidney Injury Not Uncommon After Cardiovascular Intervention

Acute kidney injury (AKI) is seen in about 7% of patients undergoing percutaneous coronary intervention (PCI) and is associated with significant in-hospital mortality.

Positive Results with ZS-9 for Hyperkalemia

ZS Pharma announced top-line results from its Extended Treatment Phase of ZS003, a Phase 3 trial of ZS-9 for the treatment of hyperkalemia.

Auxilium Submits Xiaflex sBLA for Concurrent Treatment Of Multiple Palpable Cords

Auxilium announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Xiaflex (collagenase clostridium histolyticum) for the treatment of multiple Dupuytren's contracture (DC) cords concurrently.

Neuraxial + General Anesthesia May Up Prostate CA Outcomes

Researchers found that GA alone correlated with significantly increased risk for systemic progression and elevated overall mortality within 90 postoperative days.

Long-Lasting Erections Linked to Certain ADHD Medications

The FDA is warning the public that methylphenidate products may cause priapism.

Integrated Care Endorsed for Castration-Resistant Prostate CA

For patients with castration-resistant prostate cancer (CRPC), a therapeutic framework should involve an integrated approach, with joint management by a urologist and medical oncologist

Baseline Inflammation Linked to Lower PCa Risk on Repeat Biopsy

Both acute and chronic inflammation correlated significantly with a lower risk of PCa at the two-year biopsy,

Wider Statin Use Recommended for Chronic Kidney Disease

New guidelines for lipid management in chronic kidney disease (CKD) recommend wider statin use.

First Drug Therapy for Peyronie's Disease Approved

The FDA has approved a new indication for Xiaflex (collagenase clostridium histolyticum; Auxilium) for the treatment of Peyronie's disease, a curvature deformity of the penis due to the presence of a plaque.

Optimal Testosterone Levels Tied to Survival in Older Men

Higher and lower levels of testosterone (T) and its metabolites may raise mortality risk in older men.

Testosterone Therapy Doesn't Worsen Urinary Symptoms

Testosterone replacement therapy is associated with a low risk of worsening lower urinary tract symptoms for hypogonadal men.

Stunted Growth More Likely in CKD Children from Lower-Income Families

Results from the CKiD Study found that children and adolescents with chronic kidney disease were less likely to grow to normal height ranges if they came from lower-income families, even with more prescriptions for growth hormone.

Alpha Male Pill Contains Six Hidden Ingredients

The FDA is warning consumers to not buy or use Alpha Male, a product sold for sexual enhancement.

Recall: P-Boost and NatuRECT Found to Contain Tadalafil

Tendex is recalling one lot of P-Boost (Lot # F51Q) and one lot of NatuRECT (Lot # F51Q) after the FDA determined the products contained undeclared tadalafil. These products are sold as dietary supplements for sexual enhancement.

Renal Denervation Viable for Achieving BP Control

For patients with treatment-resistant hypertension and chronic kidney disease, renal denervation (RDN) reduces blood pressure (BP) and can slow renal function decline.

Two Companies Recall Sexual Enhancement Supplements

The FDA notified the public that Fossil Fuel Products and Jobbers Wholesale are voluntarily recalling some sexual enhancement supplements after they were found to contain several undeclared drug ingredients.

Do Renal Artery Stents Lead to Better Outcome vs. Medication-Only?

According to results from a National Institutes of Health-funded study, a commonly used stenting procedure in the renal artery appears to offer no significant improvement when added to medication-based therapy.

Retinal Damage Linked to Atrial Fibrillation

Micro-vessel disease in retina and kidneys are independently and interactively associated with higher risk of atrial fibrillation.

Counterfeit Supplement Found to Contain Sildenafil

The FDA is warning the public about a potentially harmful counterfeit male sexual enhancement supplement called ExtenZe Maximum Strength.

Enterococci, GBS Appear to Rarely Cause Acute Cystitis

But low levels of E. coli had a high positive predictive value for bladder bacteriuria.

High-Risk Gene May Predict Kidney Failure in African-Americans

According to a recent study, a gene variant commonly found in African-Americans predicts that people with that gene who also have chronic kidney disease (CKD) are twice as likely to progress to kidney failure as African-Americans without the high-risk gene and white people with CKD.

Results Announced for ZS-9 for Hyperkalemia

ZS Pharma has announced top-line results from the acute phase of its pivotal Phase 3 ZS-003 trial of ZS-9, an investigational treatment for hyperkalemia.

ASN: Calcium-Channel Blocker-Antibiotic Combo Impacts Kidneys

For older adults, co-prescription with clarithromycin vs. azithromycin and calcium-channel blockers is associated with increased risk of hospitalization with acute kidney injury.

ASN: Bardoxolone Methyl No Benefit in T2DM, Stage 4 CKD

Bardoxolone methyl does not reduce the risk of end-stage renal disease (ESRD) or cardiovascular death in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease.

ASN: Particulate Matter at Ground Zero, Albuminuria Linked

For first responders exposed to particulate matter at Ground Zero, high exposure is associated with albuminuria.

Vitalikor Sex Supplement Found to Contain Hidden Ingredients

The FDA is advising consumers to not purchase or use Vitalikor Fast Acting, a sexual enhancement supplement sold on various websites and retail stores.

Study Raises Questions About Testosterone Rx for 'Low T'

Testosterone therapy use was associated with an increased risk of adverse outcomes.

Acute Kidney Injury Increased for Some Over Last Decade

Over the last decade there has been an increase in the incidence of acute kidney injury (AKI), but a decrease in the incidence of AKI requiring dialysis, among elderly patients hospitalized with a heart attack who have undergone percutaneous coronary intervention.

Renacidin Irrigation Shipments to Resume

United-Guardian announced that Renacidin Irrigation (citric acid, glucono delta-lactone, magnesium carbonate) is available again after a series of manufacturing issues.

FDA Approves Addition to Cialis Labeling

Eli Lilly announced that the FDA has approved an addition to the Cialis (tadalafil) label to include data from a 26-week study that showed Cialis 5mg once daily started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks.

Increased Use of IMRT for Self-Referring Urologists

Use of integrated intensity-modulated radiation therapy (IMRT) has increased more among urologists in private practice.

Physical Symptoms From Prostate Biopsy Can Cause Anxiety

Problematic symptoms of prostate biopsy can lead to increased anxiety in men, even when the biopsy results are negative for cancer.

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