FDA Clears Prescription Digital Therapeutic for Women With Fecal Incontinence
leva Pelvic Health System is a noninvasive digital therapeutic intended to train and strengthen pelvic floor muscles at home.
Diarrhea
Diluent Mix-Up Prompts Recall of Firvanq Kits
Firvanq is indicated for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).
Sodium Bicarbonate Injection Recalled Due to Microbial Contamination
According to the Company, intravenous administration of the affected product could lead to “site specific infections as well as serious systemic infections which may be life-threatening.”
Reduced CDI Recurrence Observed With Investigational Microbiome Therapy
SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors.
Microbiome-Based Therapy Looks Promising for Recurrent C difficile Infection
“These positive preliminary findings represent a major step forward towards bringing an innovative, non-antibiotic option to patients that may help restore their gut microbiome,” said Per Falk, Ferring’s President and Chief Science Officer.
Dificid Approved for C. difficile-Associated Diarrhea in Pediatric Patients
The FDA has approved Dificid (fidaxomicin) for the treatment of Clostridioides difficile-associated diarrhea in adult and pediatric patients aged 6 months and older.
Persistent Diarrhea, Delirium, and Beefy Tongue: Is It Pellagra?
A recently published report describes the case of a female patient who developed pellagra, a disease caused by severe niacin deficiency rarely seen in the US. The 62-year-old patient presented to the emergency department (ED) complaining of diarrhea that had persisted for 2 months and occurred about 8 to 10 times per day. Two months…
Nerlynx Labeling Updated to Include Data on Antidiarrheal Prophylaxis
The Food and Drug Administration (FDA) has approved a labeling supplement for Nerlynx (neratinib; Puma Biotechnology) to include safety information regarding neratinib-associated diarrhea. Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy. The…
Recommendations Developed for Evaluating Chronic Diarrhea
AGA recommends fecal calprotectin, lactoferrin for screening for inflammatory bowel disease
FDA Warns of “Cure-All” Products That Actually Contain Bleach
The FDA is warning consumers to stop using products known as Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, and Water Purification Solution due to numerous reports of significant health issues.
