The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Name and Version: COMFORT FLO Humidification System, REF 2410, Humidifier Nebulizer Kit Product Code: GTIN 14026704659347 Name and Version: COMFORT FLO Humidification System with Remote Temperature Port,…
Fighting Diabetes’ Deadly Impact on Minorities
Español You inherit more than your eye and hair color from your family. You can also inherit a predisposition for diabetes, a disease that disproportionally affects racial and ethnic minorities. The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is building relationships with the American Diabetes Association (ADA) and other groups…
FDA Ensures Your Foods From Animals Are Safe
Español If you eat meat or drink milk, you want to know: Are there trace amounts of the veterinary drugs used in food-producing animals entering your diet? And if they are, are the amounts safe for human consumption? Those questions—among others—are the concern of the Division of Residue Chemistry, which is part of FDA’s Center…
Benzocaine and Babies: Not a Good Mix
Español Subscribe: FDA Consumer Health Information When a baby is teething, many a mom or dad reaches for a pain remedy containing benzocaine to help soothe sore gums. Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. But the use of benzocaine…
Caution: Some Over-the-Counter Medicines May Affect Your Driving
Español Anyone who operates a vehicle of any type—car, bus, train, plane, or boat—needs to know there are over-the-counter medicines that can make you drowsy and can affect your ability to drive and operate machinery safely. Over-the-counter medicines are also known as OTC or nonprescription medicines. All these terms mean the same thing: medicines that…
Fact or Fiction: What to Know About Smoking Cessation and Medications
[embedded content] Spanish Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully…
FDA 101: Regulating Biological Products
Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies. Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as…
FDA and Partners Working to Prevent Surgical Fires
The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error—the surgical fire. A surgical fire is a fire that occurs in, on or around a patient undergoing a medical or surgical procedure. An estimated 550 to 650 surgical fires happen every year in U.S….
Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug
[Posted 02/13/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug. When FDA approved lorcaserin…
Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots before October 2019 Model 670G (MMT-1780) – all lots before August 2019 Distribution Dates: Model 630G…