The U.S. Food and Drug Administration is warning consumers not to use Intestinomicina, a drug product manufactured in El Salvador and marketed as a treatment for infectious diarrhea and acute gastrointestinal infections. Consumers who have purchased this product should immediately stop taking it and consult with a health care provider.
Category Archives: Drug Safety Information Podcasts
FDA approves first breast ultrasound imaging system for dense breast tissue
The U.S. Food and Drug Administration today approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.
FDA releases preliminary data on arsenic levels in rice and rice products
Full data collection to be complete by end of 2012, agency prioritizes further assessment to provide scientific basis for additional recommendations
FDA warns consumers against eating mangoes from Agricola Daniella of Mexico
The FDA is warning consumers against eating mangoes from Agricola Daniella, a mango supplier with multiple plantations and a single packing house located in Sinaloa, Mexico. Testing by the FDA has found Salmonella in mangoes from this producer.
FDA approves new multiple sclerosis treatment Aubagio
he U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
FDA approves production of imaging agent that helps detect prostate cancer
The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.
FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs
The U.S. Food and Drug Administration today issued warning letters to PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, for promoting products labeled as dietary supplements with claims to treat concussions and prevent or treat post-concussion syndrome and other neurological disorders.
FDA approves new orphan drug for chronic myelogenous leukemia
Today the U.S. Food and Drug Administration approved Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.
FDA approves new treatment for a type of late stage prostate cancer
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation
The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults.