FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.
FDA has approved deferiprone (Ferriprox, ApoPharma) to treat patients with iron overload resulting from blood transfusions in patients with thalassemia who had an inadequate response to previous chelation therapy.
FDA has approved fidaxomicin and telaprevir.
A recent analysis of data from the Nurses' Health Study showed a link between physical inactivity and incident idiopathic pulmonary embolism.
An FDA Drug Safety Communication sent to healthcare professionals states that Dasatinib (Sprycel, Bristol-Myers Squibb) may increase the risk of pulmonary arterial hypertension.
FDA is now requiring prescribing information for Reclast (zoledronic acid, Novartis) to include a warning against use of the drug by patients with renal dysfunction.
An interaction between warfarin and acetaminophen may result in significant elevations of international normalized ratio (INR), putting patients at increased risk for hemorrhagic complications.
Annual flu vaccines are the best way to protect children from life-threatening pneumonia, according to new guidelines from the Pediatric Infectious Diseases Society and the Infectious Disease Society of America.
FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals), a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.
When added to usual treatment, azithromycin taken daily for 1 year decreased the frequency of chronic obstructive pulmonary disease (COPD) exacerbations and improved quality of life among patients, reported a study published August 25 in the New England Journal of Medicine.