LegalView Reports on Details of FDA Warning to Avandia Manufacturer for Withholding Avandia Study Research

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LegalView recently reported the FDA warning letter given to manufacturers of Avandia for withholding post-market research. GlaxoSmithKline failed to comply with FDA regulations and offer officials full details of 10 ongoing clinical trials.

LegalView.com, the number one resource for everything legal on the Internet, published news of the most recent Avandia update specifying the U.S. Food and Drug Administration (FDA)'s warnings to GlaxoSmithKline, makers of the type 2 diabetes drug Avandia. The warning resulted from the manufacturer's noncompliance with reporting post-marketing research information on the drug. The company did not issue the full breadth of research for 10 ongoing clinical trials that spanned from 2001 to 2007.

Avandia is a prescription medication taken orally that is given to patients suffering from type 2 diabetes to regulate blood sugar levels and to ensure that blood sugar does not become exceedingly high, which would result in diabetic shock. Avandia was first marketed in 1999 and became one of the, if not the best, top-selling diabetes drugs on the market, according to news reports. However, in May 2007 The New England Journal of Medicine released results from a study, which found Avandia patients to have a 43 percent higher risk of developing heart disease while taking the drug. Individuals who have been prescribed this drug are suggested to contact a pharmaceutical law firm, which can offer assistance on any potential Avandia lawsuit.

While officials from GlaxoSmithKline claim that the lost data later transferred to the FDA did not contain information regarding the Avandia's potential safety, the company has seen a huge loss in sales because of various potentially serious Avandia side effects that have surfaced since 2007. One such side effect seems to include a link to osteoporosis and a higher risk of bone fractures. Those who suffer from type 2 diabetes and may have fallen victim to the drugs other noted dangerous side effect, an increased risk of heart disease and heart attack, should consider contacting an Avandia attorney for counsel on the potential for developing Avandia-related litigation.

For more information on this as well as additional reports of other controversial prescription drugs, use LegalView's library of legal issues, which contains the latest on Vytorin and Zetia, the Chantix recall and has new updates on the Baxter Heparin practice area. Vytorin and Zetia are two prescription drugs given to patients who suffer from elevated levels of bad cholesterol. The drugs often work in combination and both were recently discovered to be less effective than generic versions, while costing nearly three times as much. Patients who have taken either of the drugs or a combination of both should speak with a pharmaceutical lawyer to learn about the details of developing a Zetia and Vytorin lawsuit.

Chantix is a drug used to help individuals quit smoking. In late 2007, the FDA began receiving reports from patients claiming that the drug was connected with fits of delusion, suicidal thoughts and erratic behaviors. Nearly 400 reports were made and close to 40 suicides were reported of individuals who were taking the smoking-cessation drug. The FDA began investigating the links and a Chantix recall was put into effect. However, patients who suffered because of this drug should visit the Chantix homepage to learn about what legal actions can be taken for the pain caused because of these dangerous side effects.

Also, learn more on the Heparin investigation, which continues to be an ongoing blame game between American and Chinese officials. The drug is a blood-thinner used during surgical procedures, and it prevents blood clots from forming in a patient, often a deadly risk while undergoing surgery. Makers of the drug, Baxter International Inc., allegedly received a batch of contaminated Heparin that has been linked to approximately 90 deaths and many more allergic reactions of patients administered the injectable drug. For more information and to follow the story, visit the Baxter Heparin information area at http://baxter-heparin.legalview.com/.

About LegalView:
LegalView.com is a public service brought to you by Legal WebTV Network, LLC, a Limited Liability Corporation created by a group of the nation's most highly respected law firms: Anapol Schwartz; Brent Coon and Associates; Burg Simpson; Cohen, Placitella and Roth; James F. Humphreys and Associates; Lopez McHugh; and Thornton and Naumes. For more information on the accomplishments and track records of LegalView.com's superior sponsoring law firms and to get in touch with LegalView attorneys, visit LegalView at http://www.LegalView.com.

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Katie Kelley

Alan Haburchak