Gastrohepatic Disorders

Opdivo + Yervoy Approved to Treat MSI-H/dMMR Metastatic Colorectal Cancer

By July 12, 2018

The approval was based on data from the ongoing Phase 2 CheckMate-142 study which enrolled patients with MSI-H/dMMR metastatic CRC who had received ≥1 prior line of therapy for metastatic disease (N=119).

Keytruda sBLA Granted Priority Review for Advanced Hepatocellular Carcinoma

By July 11, 2018

The sBLA is based on results from the Phase 2 KEYNOTE-224 trial, which enrolled 104 individuals with advanced hepatocellular carcinoma previously treated with sorafenib who were either intolerant to or showed progression of disease after treatment.

Hydralazine-Induced Hepatotoxicity Described in Case Report

By July 09, 2018

Symptoms in patients with short latency include fever, rash, and eosinophilia.

Blister Packs for Several Meds Recalled Due to Risk of Harm to Children

By July 09, 2018

The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.

IV Acetaminophen Minimally Helpful for Colectomy Pain

July 09, 2018

More than 1 dose of intravenous acetaminophen on postoperative day 1 was associated with lower opioid utilization (−12.4%) vs non-use, while an even stronger reduction was seen in those receiving more than one oral acetaminophen dose (−22.6%).

Occupational Exposure Limits for Heat Stress Often Exceeded: CDC

July 09, 2018

For the same 25 cases, a Heat Index screening threshold of 85 degrees Fahrenheit could identify potentially hazardous levels of workplace environmental heat when WBGT was unavailable. Six fatalities occurred when the Heat Index was <91 degrees Fahrenheit.

AMA Urges Caution With Use of Wire-Bristle BBQ Grill Brushes

July 04, 2018

Precautions should be taken, including wiping down grill after use and inspecting it for wire bristles

Gastroprotective Effects of PPIs, H2RAs Compared in Patients on DAPT

By July 03, 2018

For this study, researchers searched several large databases (from 1980 to 2016) for randomized, controlled trials (RCTs) that compared clinical outcomes in patients on DAPT taking PPIs or H2RAs.

Pembrolizumab Not Better Than Paclitaxel for Advanced Gastric Cancer

July 03, 2018

Survival no better with second-line pembrolizumab than paclitaxel for gastric, gastro-esophageal cancer

Most Bleeding Events in Non-CVD Patients Are GI-Related

June 28, 2018

The risk of a nonfatal GI bleeding event was 2.19 per 1,000 person-years in the baseline cohort, 1.77 in the non-high-risk cohort, and 1.61 in the nonmedication cohort.

Cannabinoid-Based Tx Gets Orphan Drug Designation for Autoimmune Hepatitis

By June 27, 2018

Cannabidiol is a non-psychoactive component of marijuana that does not cause intoxication or euphoria that comes from tetrahydrocannabinol.

Labeling for Nausea Drugs Used During Pregnancy Updated With New Warning

By June 27, 2018

The Warnings and Precautions section for both products has been updated to inform clinicians that there have been reports of false positive urine screening tests for methadone, opiates, and phencyclidine phosphate (PCP) with doxylamine succinate/pyridoxine hydrochloride use.

Biologic Therapies Compared in Patients With Moderate-to-Severe Crohn's Disease

By June 20, 2018

For this study, researchers identified randomized controlled trials that included adults with moderate-to-severe CD treated with various biologic agents (i.e., infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab) as first- or second-line therapies compared with placebo or an active comparator.

Pharmacologic Tx Should Be Used Sparingly for Reflux in Preemies

June 19, 2018

There is a lack of evidence for efficacy of pharmacologic agents and emerging evidence of significant harm; consequently, these agents should be used sparingly, if at all.

A4250 Granted Rare Pediatric Disease Designation for Progressive Cholestasis

By June 13, 2018

The first patient has been enrolled in PEDFIC-1, a phase 3, single, randomized, double-blind, placebo-controlled trial designed to evaluate A4250 in 60 patients (aged 6 months-18 years) with PFIC subtype 1 or 2 who have elevated serum bile acid (sBA) levels and pruritus.

Addition of Bezafibrate Beneficial in Primary Biliary Cholangitis

June 13, 2018

The researchers found that 31% of the patients assigned to bezafibrate had a complete biochemical response (normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin as well as a normal prothrombin index) vs none assigned to placebo.

Honey + Sucralfate May Reduce Injury After Accidental Button Battery Ingestion

By June 11, 2018

Noting that infants and children who ingest button batteries can experience esophageal damage leading to significant morbidity and death in as little as 2 hours, researchers from the Children's Hospital of Philadelphia and Nationwide Children's Hospital aimed to identify effective options for mitigating these effects by testing common weakly acidic household beverages, viscous liquids, and sucralfate (Carafate).

DDW: Psych Disorders Make GERD Hard to Dx by Symptoms Alone

June 06, 2018

The researchers found that the mean DeMeester score was 44 ± 33 for GERD+ and 7 ± 4 for GERD−. For GERD+ and GERD−, the mean HADS scores for anxiety (8 for both; P=0.2) and depression (5 and 6, respectively; P=.3) did not differ significantly.

Stelara Linked to Reduced Rates of Hospitalization, Surgery in Crohn's Disease

By June 04, 2018

The new analysis pooled patients from the UNITI-1 and UNITI-2 trials who had clinical response after a single intravenous (IV) dose of ustekinumab and entered a 5-year follow-up period.

FDA Approves New Treatment Option for Ulcerative Colitis

By May 30, 2018

The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.

Consensus Guidelines for the Prevention of Postoperative Nausea and Vomiting

May 30, 2018

The latest Consensus Guidelines for the Management of PONV (CGM-PONV) recommend an assessment of a patient's baseline risk for PONV using a validated risk score based on independent predictors.

HCV Guidelines Updated to Include Recommendations for Key Populations

By May 25, 2018

The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.

Ingestible Device Could Monitor Gastrointestinal Health

May 25, 2018

"IMBEDs enable new opportunities for gastrointestinal biomarker discovery and could transform the management and diagnosis of gastrointestinal disease," the authors write.

Review Provides Recommendations for Effective PPI Discontinuation

By May 24, 2018

According to the review, a substantial number of patients can effectively decrease or completely discontinue use of PPIs, as often these agents are prescribed without an appropriate reason.

FDA to Review Aemcolo for Treatment of Travelers' Diarrhea

By May 23, 2018

A Phase 3 clinical trial of patients with travelers' diarrhea demonstrated that Aemcolo was superior to placebo (P=.0008) and non-inferior to ciprofloxacin.

Homeopathic Products for Teething, Nausea, Colic, Cough Recalled

By May 18, 2018

Recalled products include Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir.

FDA Approves Hemospray to Treat Non-Variceal GI Bleeds

By May 09, 2018

The product is a single-use device that delivers hemostatic powder through the channel of an endoscope.

Akynzeo for Injection Available for Chemotherapy-Induced Nausea, Vomiting

By May 08, 2018

The intravenous formulation combines fosnetupitant (prodrug of netupitant), a substance P/NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist.

New Bowel Prep Option for Colonoscopy Gets FDA Approval

By May 07, 2018

The approval of Plenvu was based on multiple clinical trials including the NOCT study which compared Plenvu to the trisulfate bowel cleansing solution Suprep (sodium sulfate, potassium sulfate, magnesium sulfate oral solution; Braintree Laboratories) using a 2-day evening/morning split-dosing regimen.

HBV Reactivation Examined in Patients Treated With TNF Antagonists

By May 03, 2018

The authors examined data from 8887 individuals who began TNF antagonist treatment for an autoimmune disease from 2001 through 2010 and were followed through 2012; 52% of these patients were screened for HBV before treatment.