All Entries in the "Dangerous Drugs" Category
Senate Report Questions Avandia
Baucus, Grassley Release Finance Committee Report on Diabetes Drug Avandia, Express Concern About FDA’s Role in Protecting Patients in Ongoing Avandia Study
WASHINGTON – Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a twoyear inquiry of the diabetes drug Avandia. The senators [...]
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
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.
Exjade (deferasirox): Boxed Warning
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
FDA requires risk management plan and class-labeling changes for all LABAs.
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
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.
Zyprexa (olanzapine): Use in Adolescents
Clinicians should consider the potential long-term risks when prescribing to adolescents.
Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
Tysabri (Natalizumab): Update of Healthcare Professional Information
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension
Risk information added to Warnings/Precautions section and data summary provided
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.