FDA Alerts
FDA to Require Warnings on Sunlamp Products
Today, the U.S. Food and Drug Administration issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices.
FDA Approves New High-Intensity Sweetener Advantame
The Food and Drug Administration today announced the new food additive, advantame, is safe for use as a general-purpose sweetener and flavor enhancer in food, except meat and poultry.
FDA Gives Thumbs Up to New IBD Rx
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
FDA Compares Risks of Pradaxa and Warfarin
FDA research has taken a closer look at the risks of two medications commonly used to lower the risk for stroke and blood clots.
FDA Approves Rx to Lower Heart Attack and Stroke Risk
The FDA has approved a medication to lower various cardiovascular risks in certain high-risk patients.
Salmonella Risk Prompts Company to Recall Organic Eggs
Sixdog Investments, LLC is voluntarily recalling some cases of their certified organic eggs, because of the potential they are contaminated with Salmonella. This voluntary field action was initiated because of routine testing results, and not because of illness to date from consumption.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare c...
Mangoes Recalled Due to Possible Health Risk
Pacific Organic Produce, San Francisco, CA is voluntarily recalling a limited number of cases of organic Tommy Atkins mangos (PLU numbers 94051 & 94959) that were sold under the Purity Organic brand.
FDA Advises Against Use of GenStrip Blood Sugar Test Strips
GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips—this means that the test strips are not made by the same company as the meter with which they are used.
FDA Approves Zykadia for Late-Stage Lung Cancer
The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
FDA Likely to Address Risks of Surgical Mesh
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP).