FDA Alerts
FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.
FDA Approves Anti-Clotting Drug Savaysa
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Whole Foods Recalls Cheeses Due to Listeria Risk
Whole Foods Market is recalling cheese sold in Arizona, California and Hawaii that came from its supplier Bleating Heart Cheeses because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Cumin Products Recalled for Undeclared Peanut Protein
Adams Flavors, Foods & Ingredients of Gonzales, Texas is voluntarily recalling cumin products because they may contain undeclared peanut proteins.
FDA Approves Weight-Management Drug Saxenda
The U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
B-Lipo Contains a Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use B-Lipo, a product promoted and sold for weight loss on various websites and in some retail stores.
Slim-K Contains Hidden Drug Ingredients
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Slim-K, a product promoted and sold for weight loss on various websites and in some retail stores.
FDA Approves New Antibacterial Drug Zerbaxa
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
FDA Approves Viekira Pak to Treat Hepatitis C
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
FDA Approves Lynparza to Treat Advanced Ovarian Cancer
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.