FDA Alerts
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
Drug Approved for Gaucher Disease
The U.S. Food and Drug Administration approved Elelyso ( taliglucerase alfa ) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.
Levaquin Approved for Treatment of the Plague
The U.S. Food and Drug Administration (FDA) today approved Levaquin ( levofloxacin ) to treat patients with plague, a rare and potentially deadly bacterial infection.
FDA Challenges Marketing of Dimethylamylamine Products
The U.S. Food and Drug Administration issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine , more popularly known as DMAA , for marketing products for which evidence of the safety of the product had not been submitted to FDA.
New Erectile Dysfunction Drug Stendra Approved
The U.S. Food and Drug Administration approved Stendra ( avanafil ), a new drug to treat erectile dysfunction.
Afinitor for Non-Cancerous Kidney Tumors
The U.S. Food and Drug Administration approved Afinitor ( everolimus ), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas ) not requiring immediate surgery in patients with tuberous sclerosis complex ( TSC ).
Votrient for Advanced Soft Tissue Sarcoma
The U.S. Food and Drug Administration approved Votrient ( pazopanib ) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy.
Victrelis and HIV Drug Interactions
The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis ( boceprevir ), a hepatitis C virus ( HCV ) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time.
Because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz ( atazanavir ), ritonavir-boosted Prezista ( darunavir ), and Kal...
FDA Strengthens Post-Marketed Drug Research
A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public.
FDA: Blood Pressure Medication Warning
The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors ( ACEIs ) and angiotensin receptor blockers ( ARBs ) in patients with diabetes or kidney (renal) impairment.