The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Category Archives: Drug Safety Information Podcasts
FDA: Risk of oral birth defects in children born to mothers taking topiramate
New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis
The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).
FDA prompts removal of unapproved drugs from market
The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products.
FDA approves new drug to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
FDA: Advanced genomic test helps trace sources of foodborne illness outbreak
FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection. PCE
FDA: U.S. Marshals seize food products at Tennessee company
U.S. Marshals today seized about $200,000 worth of food products from Bedford Cheese Store Inc. in Shelbyville, Tenn., after U.S. Food and Drug Administration investigators found evidence of rodents throughout the company’s facility. SY
FDA and Georgetown University Medical Center announce partnership
The U.S. Food and Drug Administration and Georgetown University Medical Center (GUMC) today announced a new partnership to stimulate innovation in regulatory science, ethics, education, and training. The partnership enhances the capabilities of both institutions to meet their common goal of improving public health.
FDA approves Edarbi to treat high blood pressure
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
Advanced genomic test helps trace sources of foodborne illness outbreak
FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection. PCE