The U.S. Food and Drug Administration today issued a warning letter to Breathable Foods Inc., makers of AeroShot, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol.
Category Archives: Drug Safety Information Podcasts
FDA approves two new pancreatic enzyme products to aid food digestion
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.
FDA approves first quadrivalent vaccine to prevent seasonal influenza
FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved today by the U.S. Food and Drug Administration. FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains.
FDA reaches $1 million settlement with Pennsylvania medical device firm
The U.S. Food and Drug Administration has reached a $1 million civil money penalty settlement with Globus Medical Inc., of Audubon, Pa., for the distribution of unapproved medical devices.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration (FDA).
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
FDA approves first Helicobacter pylori breath test for children
The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2012.
Federal government gains permanent injunction against raw milk producer
A federal court has granted the U.S. Food and Drug Administration a permanent injunction preventing Daniel L. Allgyer and his Rainbow Acres Farm from distributing raw milk and raw milk products in final package form for human consumption across state lines.
FDA acts to bolster supply of critically needed cancer drugs
The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages.
FDA approves Korlym for patients with endogenous Cushing’s syndrome
Today, Korlym (mifepristone) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.
FDA approves Zioptan to treat elevated eye pressure
On February 10, the U.S. Food and Drug Administration approved Zioptan (tafluprost ophthalmic solution) to help reduce elevated eye pressure in people with open-angle glaucoma.