FDA Alerts
(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: 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.
FDA warns about counterfeit ExtenZe dietary supplements
The U.S. Food and Drug Administration is warning consumers about a potentially harmful product represented as “ExtenZe ,” a dietary supplement for male sexual enhancement. The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers.
Public Notification: “Slim Xtreme Herbal Slimming Capsule” Contains Undeclared Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Slim Xtreme Herbal Slimming Capsule,” a product for weight loss sold on various websites and distributed by Globe All Wellness. The company falsely claims on the label that the product is “100% natural.”
FDA laboratory analysis confirmed that “Slim Xtreme Herbal Slimming Capsule” contains sibutramine . Sibutramine is a controlled substance that was withdrawn from the U.S. market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substa...
FDA issues first new rules under Food Safety Modernization Act
The U.S. Food and Drug Administration (FDA) today announced two new regulations that will help ensure the safety and security of foods in the United States.
New Test Detecting Diarrhea-Causing Infection
The FDA has approved a test that detects an infection that causes diarrhea, other intestinal problems and sometimes death.
Dental Pain Reliever May Be Dangerous
The FDA continues to receive reports about a life-threatening side effect of a dental pain reliever called benzocaine .
Don't Overdose on these Vitamins
The FDA is warning consumers to stop using Soladek , a vitamin-solution product, because the product may contain dangerously high levels of vitamins A and D.