The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
Category Archives: Drug Safety Information Podcasts
FDA approves first drug formulated for children with rare brain tumor
The U.S. Food and Drug Administration today approved Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of the anti-cancer drug Afinitor (everolimus) used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor.
FDA approves new combination pill for HIV treatment for some patients
The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
FDA: U.S. Marshals seize food products at Fremont, Calif., warehouse
U.S. Marshals have seized food products stored in a Fremont, Calif., company’s warehouse after inspectors from the U.S. Food and Drug Administration found widespread and active rodent infestation.
FDA announces recall of cantaloupe by Chamberlain Farms of Owensville Indiana
• The U.S. Food and Drug Administration is announcing a recall of cantaloupe by Chamberlain Farms, of Owensville, Indiana, because of possible contamination with Salmonella Typhimurium associated with a multi-state outbreak of salmonellosis
FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium
The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan Plus Premium, contain several potentially harmful active pharmaceutical ingredients that are not listed on the product labels.
FDA approves first generic Actos to treat type 2 diabetes
The U.S. Food and Drug Administration today approved the first generic version of Actos (pioglitazone hydrochloride) tablets. Along with diet and exercise, pioglitazone is used to improve blood glucose control in adults with type 2 diabetes.
FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment
The U.S. Food and Drug Administration recommended today that patients who have implantable heart defibrillators with Riata and Riata ST leads, manufactured by St. Jude Medical, should have X-rays or other imaging alternatives to check for abnormalities in the insulation surrounding the lead, which is a wire attached to the device that is inserted into the heart.
FDA warns of risk of death from codeine use in some children following surgeries
The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy).
FDA approves vaccines for the 2012-2013 influenza season
The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.