March 15, 2010Warning: Counterfeit Alli Warning: Counterfeit Alli
FDA warns of counterfeit weight-loss drug Alli 60 mg capsules (120 count refill pack) sold over the Internet. Source: www.fda.gov Recalls and Safety Alerts: Valproate Sodium and Birth Defects FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and... Source: www.accessdata.fda.gov March 14, 2010FDA Announces New Boxed Warning on Plavix FDA Announces New Boxed Warning on Plavix
The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. Source: www.fda.gov FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 26, 2010 The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame. Source: www.fda.gov International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions. Source: www.fda.gov March 13, 2010FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry
The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act. Source: www.fda.gov FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis. Source: www.fda.gov FDA Approves Therapy to Treat Gaucher Disease The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease. Source: www.fda.gov La FDA advierte a los consumidores en Puerto Rico acerca de la presencia de una bacteria dañina en desinfectantes para manos La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) está advirtiendo a los consumidores en Puerto Rico acerca de un alto contenido de la bacteria Burkholderia cepacia en los desinfectantes para manos: "Bee-Shield Hand Sanitizer” con Aloe Vera ( botellas de 10 onzas o de un galón) y “MD Quality Hand Sanitizer” con Aloe Vera (botellas de 10 onzas). La bacteria Burkholderia cepacia puede causar infecciones graves en las personas. Source: www.fda.gov FDA Issues Warning on Counterfeit Surgical Mesh The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists. Source: www.fda.gov FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. It is often blended with other spices to make seasonings that are used in or on foods. There are no reports of consumer illness associated with this recall. Only HVP manufactured by Basic Food Flavors is involved in this recall. Source: www.fda.gov Recalls and Safety Alerts: Valproate Sodium and Birth Defects FDA is reminding healthcare professionals and patients about an increased risk of birth defects in infants whose mothers took valproate sodium and related products during pregnancy. These drugs, which are used to treat epilepsy, bipolar disorder and... Source: www.accessdata.fda.gov FDA Announces New Boxed Warning on Plavix The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. Source: www.fda.gov |
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