FDA Alerts
FDA Approves New Breast Cancer Test
The U.S. Food and Drug Administration (FDA) today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin ( trastuzumab ), a commonly used breast cancer treatment.
Medication Errors Resulting From Name Confusion
The U.S. Food and Drug Administration (FDA) is alerting the public to medication error reports in which patients were given risperidone ( Risperdal ) instead of ropinirole ( Requip ) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
US Nutrition Issues Allergy Alert
US Nutrition, of Ronkonkoma , New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared fish (fish gelatin). People who have an allergy or severe sensitivity to fish run the risk of a serious or life-threatening allergic reaction if they consume these products.
Global Wellness, LLC Conducts a Nationwide Voluntary Recall of VIA XTREME ULTIMATE SEXUAL ENHANCER
Global Wellness, LLC. Hollywood, FL is conducting a voluntary nationwide recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN to the consumer level. The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers.
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs)
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
(UPDATE 12/15) FDA Announces New Safety Recommendations For High-Dose Simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy , particularly during the first 12 months of use.
Kashi Recalls Select Frozen Pizzas
Kashi is recalling approximately 11,000 cases of frozen pizzas, including Mediterranean Thin Crust Pizza, Roasted Vegetable Thin Crust Pizza, and Mushroom Trio and Spinach Thin Crust Pizza due to possible plastic fragments in an ingredient in the pizza crusts.
FDA Safety Alert: Women's Health
The U.S. Food and Drug Administration (FDA) is informing the public about new information that is being assessed as part of their ongoing safety review of birth control pills that contain drospirenone . This review will further evaluate the risk of blood clots in women who use these products.
FDA approves treatment for Clostridium difficile infection
The U.S. Food and Drug Administration today approved Dificid ( fidaxomicin ) tablets for the treatment of Clostridium difficile-associated diarrhea ( CDAD ).
FDA: Do not feed SimplyThick to premature infants
The FDA is warning parents, caregivers and health care providers not to feed SimplyThick , a thickening agent for management of swallowing disorders, to infants born before 37 weeks.