Archive for February, 2010
The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.
The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
FDA requires risk management plan and class-labeling changes for all LABAs.
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
Walong Marketing, Inc. of Buena Park, California is voluntarily recalling Flying Horse Black and White Sesame Chewy Candy due to undeclared peanuts. People who have severe sensitivity to peanuts run the risk of serious or life threatening allergic reactions if they consume this product.
Tags: food allergy
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.