Avandia – also known as Rosiglitazone – is a blood sugar control medication used for type II diabetes patients. Avandia has been on the market for 9 years and has been prescribed to millions of patients. Recently, studies have surfaced that bring the Avandia’s safety into question. During the past year the drug has been under close scrutiny by the FDA in response to reports of increased risk of heart attack, heart failure, osteoporosis and other potentially life-threatening side effects of Avandia.
A public safety advisory was issued in 2007 to warn Avandia patients of the cardiovascular risk associated with the drug’s use. However, the FDA has not issued an Avandia recall, claiming that sufficient evidence as to the dangers versus the benefits of the the drug does not exist. Currently, Avandia’s manufacturer and other researchers are conducting additional studies to determine the safety level of Avandia. In the meantime, patients across the United States have experienced adverse medical events related to the use of the drug and many have filed Avandia lawsuits.
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Avandia is a doctor-prescribed oral medication for glycemic control manufactured by health care company GlaxoSmithKline. Also known as Rosiglitazone – a part of the thiazolidinedione, or “glitazone” family – Avandia works to manage blood sugar levels in type II diabetes patients. Avandia is not for type I diabetes patients, who are dependent on insulin; it is a blood sugar control medication that is meant to work in tandem with healthy diet and exercise to balance insulin levels. At this time, Avandia is still available as a prescription medication, and is currently under continued review by the FDA. Avandia is a brand name medication and there is no generic version of Avandia on the market, although there are medications manufactured by other companies, such as Actos, that are similar in purpose and effect. Avandia has been on the market for approximately 9 years, and an estimated 6 million people worldwide have taken or are currently taking Avandia.
In the past year or so, Avandia has come under fire for reports of cardiovascular risk. In May of 2007 the New England Journal of Medicine published a study that claimed Avandia puts users at a significantly increased risk of heart attack and other dangerous cardiac events. This study, completed by the Cleveland Clinic, analyzed the results of 42 previous studies of Avandia involving over 27,000 patients. The results showed a 43% increase in heart attacks and a 64% increase in fatal cardiac events in patients taking Avandia versus those not taking the drug.
Following this publication, the FDA issued a public safety warning and requested a black box warning for Avandia and Actos. A black box warning is the most serious warning the FDA can issue, requiring safety and risk information to be printed on the drug’s packaging. Despite calls to pull Avandia from the market completely, the FDA has not taken any such action. GlaxoSmithKline claims that there is no clear and present danger to Avandia users and that the evidence from previous clinical trials is not consistent enough to draw any solid conclusions as to Avandia’s potential heart risk. GlaxoSmithKline has been asked to complete additional studies to produce more conclusive results and is currently in the process of doing so. Read more here about Avandia and heart problems.
In addition to heart problems, Avandia has a number of other risks and side effects including osteoporosis, liver damage and vision problems. Get more information on Avandia side effects.
On this website you will find a variety of resources providing you with information, data and assistance with your Avandia questions. If at any time you feel that you have a legal issue in connection with Avandia, please use the form provided to contact a qualified Avandia lawyer. A law firm in your area will be in touch with you to assess your Avandia case and provide a free consultation.
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