FDA Alerts
Two New IBS Treatments Approved
The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
FDA Approves Generic Version of Nexium
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older.
FDA Approves Movantik for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.
FDA Gives Thumbs Up to New IBD Rx
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
Some Lots of Simply Lite Brand Dark Chocolate Recalled
People read ingredient labels on food packaging not only to see if a food has healthy ingredients, but also to see if that food contains anything they're allergic to. One brand of chocolate bar seems to have left one ingredient off of its label.
FDA: Don't Prescribe Rx Combos With Too Much Acetaminophen
FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per tablet, capsule or other dosage unit.
FDA Safety Warning About OTC Constipation Medications
FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death.
FDA Approves First Generic Versions of Aciphex Delayed-Release Tablets to Treat GERD
The US Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
FDA Defines Gluten-Free for Food Labeling
The US Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling.
FDA approves Simponi
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.