FDA Alerts
FDA: Sit and Slim II Contains Hidden Drug Ingredients
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II, a product promoted and sold for weight loss on various websites and possibly in some retail stores.
FDA Approves New Device to Open Blocked Arteries
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB).
Akynzeo Approved for Nausea and Vomiting from Chemo
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
FDA Takes Steps to Strengthen Cybersecurity of Medical Devices
To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
Parents Warned to Not Use Product Due to Potential Lead Poisoning Risk
FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.
FDA Adds Important Safety Information to Xolair Label
An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair.
FDA Approves New Rx for Combination with Other HIV Medications
On September 24, 2014, FDA approved Vitekta (elvitegravir) 85 mg and 150 mg tablets.
FDA Approves New Rx for Combination with HIV Medications
On September 24, 2014, FDA approved Tybost (cobicistat) 150 mg tablets. Tybost is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection.
FDA Approves New Use of Glucose Monitoring System for Hospitals
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized.
Gold Star Smoked Fish Recalls Cold Smoked Steelhead
Gold Star Smoked Fish Corp., located at 570 Smith Street, Brooklyn, NY 11231, is recalling Cold Smoked Steelhead in Vacuum Pack with blue and gold label due to contamination or possible contamination with Listeria monocytogenes .