FDA Pronouncements on Vitamins
April 16, 2008 14:34

When it comes to FDA pronouncements most people assume these pronouncements are based exclusively on pharmaceutical drugs. This is why when the FDA announced potential recalls on vitamins many people found this surprising. But, it should not be surprising that the FDA opted to remove potentially harmful vitamins from the marketplace. After all, the role of the FDA is to protect consumers from harmful products that fall under the category of food or drugs and vitamins definitely fit into those categories. And even if they did not is it not a good thing that harmful products are being removed from store shelves.

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Date: Wed, 23 May 2007 11:18:46 -0400 From: CDER MEDWATCH LISTSERV Subject: FDA - MedWatch - Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging: FDA Requests That A Boxed Warning and New Warnings Be Added To Prescribing Information MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of nephrogenic systemic fibrosis (NSF) to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73 square meters) and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging. Read the complete 2007 Safety Summary, including a link to the FDA Healthcare Professional Sheet, FDA News Release, and Q & A Document regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium _________________________________________________________

Health Canada is informing Canadians that Permax, a drug used for the treatment of Parkinson's disease, has been withdrawn from the U.S. market amidst concerns about an association with cardiac valvulopathy, a condition involving inflammation or stiffening of the heart valves.

Pharmaceutical News reports that the Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

The Food and Drug Administration (FDA) in the U.S. is warning consumers against several products promoted as treatments for erectile dysfunction (ED) and sexual performance enhancers. The FDA says the products are in fact illegal drugs that contain potentially... (Read Article)