The U.S. Food and Drug Administration today approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.
Category Archives: Drug Safety Information Podcasts
FDA approves Marqibo to treat rare type of leukemia
The U.S. Food and Drug Administration today approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).
FDA revises safety information and limits use of Stryker Wingspan brain stent system
The U.S. Food and Drug Administration today approved changes to the labeling for the Stryker Wingspan Stent System, including the indications for use. These changes, which the FDA outlined in a safety communication also issued today, specify a more limited group of patients who may benefit from the system. In addition, the safety communication also describes the new contraindications for the stent system, which is used to open narrowed arteries in the brain to prevent additional strokes.
FDA approves Zaltrap for metastatic colorectal cancer
The U.S. Food and Drug Administration today approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.
FDA approves first generic versions of Singulair to treat asthma, allergies
The U.S. Food and Drug Administration today approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
Food Safety Guides for Groups Most Vulnerable to Foodborne Illness Now Available
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Services’ Food and Drug Administration (FDA) have partnered to create six booklets with food safety advice for populations that are most susceptible to foodborne illness. The booklets in this “at-risk series” are tailored to help older adults, transplant recipients, pregnant women, and people with cancer, diabetes or HIV/AIDS reduce their risk for foodborne illness.
FDA warns consumers not to eat cantaloupes from Burch Equipment LLC of North Carolina
The U.S. Food and Drug Administration is warning consumers not to eat whole cantaloupes from Burch Equipment LLC, of Faison, N.C., because of possible contamination with Listeria monocytogenes (L. mono). The company had shipped 580 cases of whole cantaloupes on July 15, which were then distributed to retail stores in New York and Maine. Consumers who may have cantaloupes with a red label displaying the words Burch Farms and referencing PLU #4319 should discard them as a precautionary measure. Cantaloupes from the North Carolina firm tested positive for L. mono following sampling carried out in New York, as part of sampling conducted through the USDA Microbiological Data Program. On July 28, 2012, Burch Equipment LLC issued a voluntary recall of the 580 cases of whole cantaloupes. No known illnesses have been reported that are linked to consumption of these cantaloupes.
FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
FDA: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief
Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
FDA warns consumers not to eat shellfish from Oyster Bay Harbor, Nassau County, NY
• The U.S. Food and Drug Administration is warning consumers not to eat raw or partially cooked oysters and clams (shellfish) with tags listing Oyster Bay Harbor, in Nassau County, N.Y., as the harvest area, following illnesses reported in several states caused by Vibrio parahaemolyticus bacteria.