On Dec. 28, the U.S. Food and Drug Administration approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
Category Archives: Drug Safety Information Podcasts
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used 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.
FDA approves new orphan drug for rare cholesterol disorder
On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.
Federal judge enters order imposing restrictions on Sunland Inc.
U.S. District Judge William P. Johnson of the District of New Mexico has signed a consent decree imposing requirements on Sunland Inc., a manufacturer and distributor of peanut products linked to an outbreak of Salmonella Bredeney, to keep potentially harmful products from entering the marketplace, the U.S. Food and Drug Administration said today.
FDA approves Varizig for reducing chickenpox symptoms
The U.S. Food and Drug Administration approved Varizig, for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals when given within four days after exposure.
FDA approves Gattex to treat short bowel syndrome
The U.S. Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
FDA expands Tamiflu’s use to treat children younger than 1 year
The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.
Invacare signs consent decree to correct wheelchair manufacturing problems
The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
FDA permits marketing of device to seal lung punctures
The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.
FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery
The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.