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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
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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
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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).
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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.
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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.
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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.
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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.
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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.
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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.
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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.
