Latest FDA News
FDA Warns about Increased Risk of Muscle Injury with Zocor
FDA Warns about Increased Risk of Muscle Injury with Zocor - Highest approved dose of cholesterol-lowering medication could cause harm to muscles…
FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
FDA today March 18th 2010 approved Carbaglu (carglumic acid)Tablets to treat too much ammonia in blood…
Statement for National Poison Prevention Week
FDA Committed to Addressing Growing National Overdose Problem The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 367,000 for opioids).…
FDA Approves First Totally Implanted Hearing System
The U.S. Food and Drug Administration today announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss.…
FDA March 17 Update on the Investigation into the Salmonella Montevideo Outbreak
As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.…
FDA Seeks Permanent Injunction Against Louisiana Sprout Grower
The Department of Justice, in an action initiated by the U.S. Food and Drug Administration, today sought a permanent injunction against A Chau Sprouting Co., a sprout grower in Gretna, La., company owner and manager Quang “Mike” Trinh, and Hue Nguyen, the company production manager.…
FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets
The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.…
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.…
FDA Task Force Seeks Public Comments on Increasing Transparency with Regulated Industry
As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.…
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.…
FDA March 11 Update on the Investigation into the Salmonella Montevideo Outbreak
March 11 Update - As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.…
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.…
FDA Update on the Investigation into the Salmonella Montevideo Outbreak - March 5, 2010
As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.…
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.…
FDA Approves Name Change for Heartburn Drug Kapidex
The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.…
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.…
FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers
The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers – "Bee-Shield Hand Sanitizer” with Aloe Vera (10 fl. oz. or 1 gallon bottles) and “MD Quality Hand Sanitizer” with Aloe Vera (10 fl oz. bottles) – contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.…
FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety Programs
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) will host a joint public workshop on how best to measure progress in reducing foodborne illnesses on March 30, in Washington, D.C.…
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.…
FDA Survey Finds More Americans Read Information on Food Labels
A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by the U.S. Food and Drug Administration.…
