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.

If you are someone who has suffered a heart attack after taking the diabetes drug avandia then you would be wise to seek counsel with a lawyer who specialized is avandia lawsuits. While some may be concerned about how difficult the process for filing an injury lawsuit this should not be a concern of the litigant as such matters should be left to the attorney. After all, they do have tremendous experience in the field and their pre-existing experience can make filing such a lawsuit much easier than most would assume. This way the litigant should not feel uneasy about the process of actually filing a lawsuit.

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In a written statement, the commissioner, Andrew C. von Eschenbach, said the agency has asked the makers of Actos and Avandia to carry the more prominent warning, a so-called black box warning, of its heart risks because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."

"A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia. And in the next year, the F.D.A. reprimanded the drug�s maker for playing down safety concerns, according to documents from 2000 and 2001. The documents, found in a reporter�s search of the F.D.A.�s database, indicate that the agency had been warned of safety concerns with the Type 2 diabetes treatment Avandia, and that the drug�s maker, GlaxoSmithKline, was seeking to minimize Avandia�s risks, before some of the same cardiovascular concerns were brought to public attention on Monday in an article and an editorial in The New England Journal of Medicine. The F.D.A. has acknowledged that the company alerted the agency to concerns about a cardiovascular risk as early as 2005, based on the company�s analysis." Stephanie Saul and Gardiner Harris, New York Times 5/24/07 http://www.nytimes.com/2007/05/24/business/24drug.html?_r=1&th&emc=th&oref=slogin

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)