Avandia Drug Lawsuit Attorneys |
Avandia Drug Lawsuit Attorneys |
Please note that we are no longer accepting new cases for Avandia. The diabetes drug Avandia has been linked to higher incidences of heart attacks and death from cardiovascular causes for patients taking this medication. If you or a loved one has been taking Avandia and encountered such problems, the Florida Law offices of Robert J. Fenstersheib and Associates, P.A., drug lawsuit attorneys , can assist you in making sure you get the proper legal help and possible compensation related to Avandia drug law suits. To make sure you understand the Avandia study leading to the product warnings, you can scroll down to read a complete Avandia News Alert. If you're like most people, you aren't sure what to do regarding a problem with the drug Avandia, and are probably asking questions like:
It is important to know your legal rights regarding any Avandia drug lawsuits. If you do not have an attorney to help you with your claim, the deck is stacked against you. The Law Offices of Robert J. Fenstersheib and Associates, P.A. have been helping Florida residents with their legal concerns for over a decade. Let us put this experience as drug lawsuit lawyers to work for you. There are two easy and convenient ways you can reach us:
As you learn more about your legal rights, please remember that our law firm offers free legal consultations, without obligation, to determine if you may have a legal case regarding an Avandia lawsuit. Our law firm will evaluate your claim free of charge and advise you on your legal rights to collect compensation – there is no obligation to use our services. The experienced drug lawsuit attorneys at the Law Offices of Robert J. Fenstersheib and Associates, P.A. can help you with your Avandia-related issues, and our firm is highly experienced in accident cases, personal injury lawsuits, breast implant settlements, slip-and-fall lawsuits as well. Call the Law Offices of Robert J. Fenstersheib and Associates, P.A. today, let us answer all your questions and help you protect your legal rights! The Avandia drug lawsuit website is registered to: the Law Offices of Robert J. Fenstersheib & Associates, P.A. who practice law in the state of Florida and offer the following services: Personal Injury, Including Automobile Accidents, Premises Liability, Defective Products, and Medical Malpractice. The website is for information purposes only and additional information can be provided by request. If you have already retained the services of an attorney for your Avandia lawsuit, please contact that firm directly. Avandia News Alert:Diabetes Drug ComplicationsIn the findings reported in the June 14 issue of the New England Journal of Medicine, Dr. Steven Nissen and his colleague Kathy Wolski evaluated 42 studies that compared patients taking Avandia with patients not using the drug. The studies included nearly 28,000 patients – 15,560 of whom were taking Avandia. The researchers found the risk of a heart attack was increased 43% among those taking Avandia. There is also a 64% increased risk of dying from cardiovascular causes while taking the drug. The implications of these discoveries were considered enough of a public health matter to have caused the New England Journal of Medicine to release the findings several weeks before they appeared in print. What is Avandia?Avandia is the brand name for an anti-diabetic drug marketed by GlaxoSmithKline. Avandia received approval from the FDA in 1999, and millions of Americans with diabetes take it to help control their blood sugar levels. Avandia, a prescription tablet available in 2-mg, 4-mg and 8-mg strength, comes in packets of 28. It can be taken once or twice daily. Why are the study findings considered a public health matter?Currently, 1 million Americans take Avandia for the treatment of Type 2 diabetes. In this form of the disease, the patient exhibits high levels of sugar in the blood because the body does not respond to insulin, a hormone released by the pancreas that helps glucose move into the cells, where it can be used for energy. How significant is Avandia's increased risk of heart attack?The overall risk appears to be small. There were 86 heart attacks and 39 deaths among the 15,560 Avandia patients in the study, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia. Nissen and Wolski concluded from this data that Avandia may be capable of provoking heart attacks or death from cardiovascular causes after relatively short-term exposure in patients who are already susceptible to these conditions. What is the FDA's response to these findings?The Food and Drug Administration urged diabetics taking Avandia to talk to their doctors about whether they should remain on the treatment. However, the agency did not issue a call for a sharper warning label on the drug. Is there a generic equivalent of Avandia?Currently, Avandia is what's known as a single-source brand, meaning there is no generic equivalent. When the patent for a brand-name drug expires, the Food and Drug Administration (FDA) can approve generic versions of the drug, which must match the brand name in dosage, strength, performance, use, quality, and safety. Avandia's patent protection expires in 2009. Are there any equivalent brand name drugs available?Takeda Pharmaceutical Co. manufactures Actos, a similar product that doesn't have a heart risk. It is a tablet with the active ingredient pioglitazone, which is also in the thiazolidinedione class of drugs. There have been reports of hepatitis and elevated liver enzymes among patients who use this drug. It has not been determined whether these conditions are directly related to Actos. Eli Lilly & Co.'s Byetta is an injectable medication in a class of drugs called incretin mimetics. They are so named because they mimic the effects of naturally occurring hormones in the intestines and can help the body make more of its own insulin. Possible side effects include an allergic reaction involving hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Merck & Co.'s Janumet is an oral medicine combining sitagliptin phosphate with metformin hydrochloride. It is designed for patients who need more than one oral medication to help control their blood sugar. Metformin hydrochloride can cause a rare but serious side effect called lactic acidosis, which is a build-up of lactic acid in the blood that can cause death. What is GlaxoSmithKline's reaction to these findings?In a May 21st press release, the maker of Avandia points to the limited nature of the study as a reason to be skeptical about the findings. The pharmaceutical company added that, in contrast, GSK has initiated the most comprehensive and rigorous program of scientific analysis for any oral anti-diabetic medicine on the market today, with experience in over 52,000 patients. The company has initiated: • Extensive clinical trials, including long-term clinical trials in diabetic patient This data shows that Avandia has a cardiovascular safety profile comparable to other oral anti-diabetic medicines. In addition, independent investigators performed a comprehensive analysis of patients in a U.S.-managed care database of more than 33,000 people with diabetes, and it showed there was no difference in cardiovascular events among patients taking Avandia- containing regimens versus other oral anti-diabetic medicines. Lawmakers Warn Drug Makers To Knock It Off After Avandia DebacleWashington, DC: On November 14, 2007, the FDA added a new black box warning to GlaxoSmithKline's diabetes drug Avandia, regarding a potential increased risk of heart attacks, in addition to the black box warning that was added in August 2007 about the increased risk of heart failure. The FDA said the new warning would also apply to Glaxo's diabetes drugs Avandamet and Avandaryl, since they both contain the same active ingredient as Avandia. However, Senator Chuck Grassley (R-Iowa), ranking member of the Senate Finance Committee, has asked the FDA to respond to accounts that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin amid considerations of a second warning. In an October 26, 2007 letter to FDA Commissioner Andrew von Eschenbach, Grassley is also asking about the terms and conditions governing public notification with this sort of information. "The Avandia case continues to present new rounds of questions about the way the FDA monitors and assesses drug risks and decides whether to let the public know about emerging risks," Senator Grassley said in an October 29, 2007 press release. Among those who voted in favor of the drug's removal was the Department of Veterans Affairs, and last month the Department announced that it was removing Avandia from its list of approved drugs and would severely limit its use. VA sales reportedly represent about 8% of total Avandia sales in the US. On June 5, 2007, the NEJM published a paper entitled, "Rosiglitazone -- Continued Uncertainty about Safety," by Dr Jeffrey Drazen, Dr Stephen Morrissey and Dr Gregory Curfman, which drew more attention to some of the safety concerns about Avandia that were first reported in a study in the New England Journal of Medicine by Cleveland Clinic Cardiologist Dr Steven Nissen in May 2007. The paper cited an analysis which indicated an increase of about 40% in the risk of myocardial infarction in patients receiving Avandia when compared to patients receiving either an oral diabetes drug such as metformin or a sulfonylurea or a placebo. "Since rosiglitazone is widely used for the treatment of type 2 diabetes and since the analysis considered all publicly available data on the topic," the authors wrote, "we published the article to make health care professionals and their patients aware of these potential adverse effects." On September 11, 2007, the Journal of the American Medical Association published two new studies on Avandia. One was a meta-analysis co-authored by Dr A. Michael Lincoff and Dr Nissen of the Cleveland Clinic, that found Avandia's main competitor, Actos, appeared to protect diabetic patients from heart attacks, stroke and death by 18%. The second study, also a meta-analysis, by researchers led by Dr Sonal Singh at Wake Forest University, concluded that Avandia increased the risk of heart attack by 42%. Heart Failure & Heart Problems If you, or someone you care about, has had heart problems related to taking avandia, you can contact our law firm for a free evaluation by:
Our law firm will evaluate your claim free of charge and advise you on your legal rights to collect compensation. There is no obligation to use our services, and "YOU PAY NO FEE UNLESS THERE IS MONEY FROM YOUR CASE". Let Attorney Robert J. Fenstersheib & Associates represent you in the Avandia Class Action Lawsuit.
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Possible Serious Side Effects Linked to AvandiaDiabetes is a serious ailment in modern America, with recent figures from the American Diabetes Association citing more than 20 million Americans afflicted with the disease, in addition to the roughly six million who live undiagnosed and the 40 million or more Americans who could be considered pre-diabetic. In response to these ever increasing numbers, pharmaceutical companies have been under a great deal of pressure to invent new and ever better diabetes drugs to combat the illness. Avandia (Rosiglitazone Maleate) is one such drug, developed by the firm GlaxoSmithKlein and approved by the Food and Drug Administration (FDA) in May of 1999. The drug comes from the Thiazolidinedione class of anti-diabetic drugs and is approved for treatment of type 2 diabetes. Like other drugs in the Thiazolidinedione class, the Diabetic Drug Avandia functions by acting on the patients insulin resistance, and also appears to have some anti-inflammatory effects. Patients should not take Avandia if they have type 1 diabetes. As with any prescription medication, patients who take Avandia have reported a number of common side effects, including: • cough or cold In addition to these more common side effects, Avandia has also been shown to cause more serious afflictions in some patients, including impairment to liver functionality, causing the FDA to warn against the drug being prescribed to patients already suffering from liver disorders. The drug can also lead to hypoglycemia, meaning that patients who have been diagnosed with any variety of hypoglycemic condition should not be prescribed Avandia. Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes. FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions. Avandia LawsuitAccording to the November 2007 report by the Senate Finance Committee, FDA scientists presented an analysis at a July 30, 2007 safety panel meeting, which estimated that Avandia caused approximately 83,000 excess heart attacks since coming on the market. The report notes that Dr John Buse, a medical researcher at the University of North Carolina, tried to sound the alarm about the increased risks associated with Avandia in 1999, and states: "Had GSK considered Avandia's increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, instead of trying to smother an independent medical opinion, some of these heart attacks may have been avoided." If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact our office. Our experienced law suit lawyers will review your case at no cost or obligation. Avandia Linked to Heart FailureBack to class action lawsuits. If you're like most people, you aren't sure what to do after an injury and are probably asking questions like:
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Florida Personal Injury Attorney Robert J Fenstersheib & Associates All rights reserved. | Contact Us | Attorney Site Map | Resources Fenstersheib Law Offices - 520 W. Hallandale Bch Blvd, Hallandale, Florida 33009 | (855) TELLROBERT | Fax: 954-252-2139 |
