Avandia Heart Attack, Stroke & Side Effects Lawsuits
In May 2007, the New England Journal of Medicine published a report suggesting that the widely-prescribed diabetes drug Avandia (rosiglitazone male ate) may significantly increase the risk of heart attack and heart-related death--especially in those who have a prior history of heart disease or who are considered at risk for a heart attack. Immediately following the report, the U.S. Food and Drug Administration issued a safety alert encouraging patients taking Avandia to consult with their doctor about possible treatment alternatives.
Individuals who have taken Avandia and suffered a heart attack or other serious health effect may be able to hold the drug's maker--GlaxoSmithKline--responsible for damages, such as medical costs and mental anguish, among other things. For a FREE case evaluation with an attorney who can determine your eligibility to seek damages, contact us today.
What You Should Know About Avandia
Avandia (rosiglitazone male ate) is an FDA approved drug used in the treatment of Type 2 diabetes, a serious condition affecting approximately 20 million Americans. Since its approval in 1992, the drug has been prescribed to as many as 10 million Americans, thousands of whom--according to one expert--have suffered Avandia-related heart problems.
Over the years, Avandia has been linked to various side effects including:
- Congestive heart failure, edema, and fluid retention
- Liver toxicity
- Low blood pressure
The findings published by the New England Journal of Medicine, however, are raising new concerns about the extent of the heart risks associated with Avandia. In an analysis of 40 studies and more than 28,000 patients, researchers found that those taking Avandia were between 30 to 40 percent more likely to suffer heart attack and heart-related death than those taking a placebo or other diabetes drug. As of May 2007, the FDA said data analyses were ongoing to confirm the risks.
Know Your Legal Rights
GlaxoSmithKline has made billions of dollars from sales of Avandia, the most popular diabetes drug in the world. Although the drug has been extremely profitable for its maker, those profits have not been without a certain cost--a cost borne by patients who have suffered harm as a result of taking Avandia.
If you or someone you love has taken Avandia and suffered a heart attack or heart-related death, make sure your legal rights are protected by contacting an attorney experienced in Avandia pharmaceutical litigation. You may be entitled to compensation for your losses and suffering.
More Avandia Resources
FDA Issues Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia. Read More...
FDA Adds Boxed warning for Heart-related Risks to Anti-Diabetes Drug Avandia
Agency says drug to remain on market, while safety assessment continues: click here to read the press announcements...
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks. Read more...
Medline Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.
Avandia (rosiglitazone maleate) Tablets (Posted 11/14/2007)
Avandia (rosiglitazone maleate) Tablets (Posted 08/14/2007)
Avandaryl (rosiglitazone maleate and glimepiride) Tablets (Posted 08/14/2007)
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets (Posted 08/14/2007)
Avandamet (rosiglitazone maleate and metformin hydrochloride) (Posted 02/20/2007)
Avandaryl (rosiglitazone maleate and glimepiride) (Posted 02/20/2007)
Avandia (rosiglitazone) (Posted 05/21/2007)
Avandia (rosiglitazone maleate) (Posted 02/20/2007)
http://www.fda.gov/Medwatch/SAFETY/2007/Avandia_GSK_Ltr.pdf
Avandia Death Risk
According to an analysis of clinical data published May 21, 2007 in New England Journal of Medicine, the diabetes drug Avandia may significantly increase the risk of death due to cardiovascular problems. A meta-analysis of more than 40 trials indicated that diabetic patients treated with Avandia faced a greater risk of heart-related death than those treated with other diabetes drugs or a placebo. The analysis also revealed a 43% increased risk of heart attack among Avandia-treated patients.
To learn more about your legal options, contact us today.
History of Avandia Death Risk
Documents uncovered after the NEJM published its May 2007 report reveal that the U.S. Food and Drug Administration was aware of the potentially fatal cardiovascular risks associated with Avandia as early as 2000. GlaxoSmithKline, however, downplayed the risks at the time and was allowed to continue marketing the drug. The risks surfaced again in 2005, but again, no action was taken.
Avandia Side Effects
Since its approval in the early 1990s, Avandia has become the world’s top-selling diabetes drug. Despite its widespread use, Avandia has been linked to a number of serious side effects. In addition to Avandia death risk and heart attack, the drug has been associated with:
- Low blood pressure
- Liver toxicity
- Congestive heart failure (including related effects such as edema)
FDA Safety Alert
People with Type 2 diabetes, the most severe form of diabetes, already have a higher-than-normal risk of cardiovascular problems. Use of a diabetes drug that may boost the risk of heart attack and other heart problems such as Avandia is consequently considered controversial.
Immediately after the NEJM released the Avandia findings, the FDA issued a safety alert to physicians and consumers. According to the safety alert, patients with a history of cardiovascular problems or with an increased risk of heart attack face the highest risk of suffering a heart attack or heart-related death while taking Avandia and are thus encouraged to discuss alternative treatments with their medical providers.
Avandia Diabetes
Avandia diabetes drug was approved primarily as a safer alternative for diabetes patients following the recall of Rezulin. The FDA never found Avandia diabetes drug to be safe, rather it appeared to pose a lesser risk of liver damage than Rezulin had. Despite Avandia diabetes drug approval, the FDA still maintained the agency would continue watching for signs of serious complications with diabetes patients using it.
Public Citizen consumer group pushed to have Rezulin removed from the market long before the actual recall and never found Avandia diabetes drug to be a safe alternative for patients. The FDA sent Avandia manufacturer a warning letter after finding the company was violating regulations. The Avandia manufacturers were promoting Avandia while minimizing the serious risks associated to the diabetes drug. The FDA had already objected to Avandia promotional materials, however, the Avandia manufacturer had still failed to discontinue misleading Avandia promotions.
If you would like more information, please contact an Avandia lawyer.
Avandia Linked to Pulmonary Edema and Heart Failure
September 8, 2003
In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The FDA announced at the time of Rezulin recall that Acts and Avandia were safer alternative in "this important class of diabetes drug," which Rezulin was the first FDA approved drug of the newest class. Public Citizen consumer group criticized the FDA for waiting too long to issue the Rezulin recall and remained skeptical that other drugs, such as Avandia, would not also cause problems.
Now, a new study published in the September 9 issue of the Mayo Clinic Proceedings has reported that congestive heart failure can occur in Avandia patients. Already known to cause fluid accumulation, Avandia is now being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency until further Avandia studies have been performed.
Avandia Heart Attack
Concerns over the top-selling diabetes drug Avandia began to mount in May 2007 when the New England Journal of Medicine published an article on its website linking the drug to a significant risk of heart attack and heart-related death. The news immediately raised anxieties among consumers and medical professionals, but even worse, reports surfaced several days later revealing that the Food and Drug Administration was aware of Avandia’s heart attack risks as early as 2000. Despite their knowledge of the drug’s dangers, neither the FDA nor Avandia’s maker—GlaxoSmithKline—took action to protect consumers.
Millions of Americans have taken Avandia as a treatment for Type 2 diabetes, and many have suffered Avandia heart attack and other adverse effects as a result. Those who have may be entitled to hold GlaxoSmithKline liable for damages.
Contact us today to learn more.
Avandia Heart Risks
According to a meta-analysis of more than 40 studies and 28,000 patients, Avandia increases the risk of heart attack and heart-related death by 30 to 40 percent compared with placebo or other diabetes drugs. Patients facing the greatest risk of Avandia heart attack are those with a history of heart disease or who are already considered at risk of heart attack.
The FDA said in a safety alert that it would continue to evaluate these findings, but if confirmed, the implications are nothing short of devastating. Avandia has been prescribed to as many as 10 million Americans with Type 2 diabetes, and diabetes patients already face a higher risk of cardiovascular problems than the general population. One expert estimates that thousands of Avandia users have suffered drug-related heart attack.
Avandia & Your Legal Rights
If you or someone you love has suffered an Avandia heart attack or heart-related death, it is important to understand the legal remedies available to you. You may be entitled to reimbursement for your:
- Medical costs
- Lost earnings
- Loss of companionship
- Mental anguish
- Pain and suffering
Avandia Lawsuit
Avandia lawsuits have resulted because of the serious Avandia side effects that have been reported. When Rezulin diabetes drug was recalled Avandia was intended to replace it as a safer alternative, however the consumer group Public Citizen never recognized Avandia to be a safe alternative. Avandia lawsuits have resulted because serious side effects as a result of using Avandia have surfaced, including congestive heart failure, hepatitis, and liver failure.
If you would like more information on your legal rights and options regarding Avandia lawsuits, please contact an Avandia lawyer.
The FDA has sent letters to Avandia manufacturer regarding the promotional activities for Avandia. Avandia lawsuits have resulted, because of the serious Avandia side effects and because Avandia manufacturer minimized the risks associated with Avandia. In particular, the FDA warned Avandia manufacturer of the "oral representations denying the existence of serious new risks associated with Avandia at GSK's promotional exhibit booth" in September 2001. When Avandia was approved the FDA stated they were not confident of its safety regarding liver toxicity, just that Avandia appeared to be safer than Rezulin, a factor that Avandia lawsuits may point out.
September 8, 2003
In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The FDA announced at the time of Rezulin recall that Acts and Avandia were safer alternative in "this important class of diabetes drug," which Rezulin was the first FDA approved drug of the newest class. Public Citizen consumer group criticized the FDA for waiting too long to issue the Rezulin recall and remained skeptical that other drugs, such as Avandia, would not also cause problems.
Now, a new study published in the September 9 issue of the Mayo Clinic Proceedings has reported that congestive heart failure can occur in Avandia patients. Already known to cause fluid accumulation, Avandia is now being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency until further Avandia studies have been performed.
Contact us today to learn more.
Avandia PPH
Avandia is a widely prescribed drug used to help patients with diabetes control blood sugar levels. In May 2007, however, concerns started mounting in the healthcare community about the devastating side effects of the drug—some of which were known since 2000. One of the most serious health effects associated with Avandia is the onset of primary pulmonary hypertension, or PPH. A rare condition that causes the narrowing of blood vessels and consequently high blood pressure, PPH is a precursor to heart failure.
If Avandia use caused you or a loved one to develop PPH, an experienced defective drug attorney may be able to help you hold GlaxoSmithKline (GSK) responsible for your damages.
contact an Avandia lawyer to learn more.
Black Box Warning
In June 2007, the Food and Drug Administration ordered GSK to add a black box warning—the strongest level of warning—to Avandia's label alerting consumers and medical professionals of the increased risk of heart failure. PPH is considered a precursor to heart failure, and early symptoms are usually minor. Consequently, diagnosis of PPH in Avandia patients may be delayed. Avandia patients should seek medical attention immediately if they begin to experience any of the following:
- Extreme fatigue
- Shortness of breath
- Chest pain
- Swelling in the ankles
- Dizziness, weakness, or loss of consciousness
- Bluish coloring of the skin or lips
Depending on the extent of the illness at the time of diagnosis, an Avandia PPH patient may require a heart-lung transplant. In the most severe cases, Avandia PPH may result in death.
Avandia, PPH, & Other Side Effects
In addition to PPH, Avandia has also been linked to liver toxicity, low blood pressure, and a 30 to 40 percent increased risk of heart attack. According to one expert's estimate, thousands of type 2 diabetes patients who have taken Avandia have suffered severe side effects such as heart attack and death .
Avandia is the world's top-selling diabetes drug and has been prescribed to more than 10 million Americans. If you or someone you love has been diagnosed with PPH while taking Avandia or suffered some other adverse health effect, an attorney can help you understand your legal options. You may be entitled to reimbursement for your losses.
Avandia Side Effects
In recent years, evidence linking Avandia to serious side effects such as pulmonary edema, heart attack and heart failure has mounted. Some studies suggest that Avandia increases the risk of heart attack by 30 to 40 percent. The risk of Avandia side effects has not yet prompted a withdrawal of the drug from the market, although an FDA panel met in July 2007 to discuss the drug's future.
If your or your loved one suffered a severe Avandia side effect, let an attorney evaluate your case free of charge. You may be entitled to reimbursement for your losses.
Avandia Side Effects: Mild to Life-Threatening
The side effects an individual may suffer typically depends on a number of factors, including a person's overall health and medical history. Depending on these and other factors, Avandia side effects can range from mild to life threatening.
Some of the more mild Avandia side effects include headache, fatigue, back pain, and sinusitis, among others. However, Avandia has also been linked to more dangerous side effects such as:
* Edema
* Heart problems
* Heart failure
Individuals who are taking Avandia and experience fluid retention or swelling, shortness of breath, unusual tiredness or increase in weight should consult with a physician immediately.
In 2000, Rezulin diabetes drug was recalled after being linked to dozens of fatal liver disease instances. The FDA announced at the time of the Rezulin recall that Acts and Avandia were safer alternatives for managing Type 2 diabetes. At the time, the consumer group Public Citizen criticized the FDA for waiting too long to issue the Rezulin recall and remained skeptical that other drugs, such as Avandia, would not also cause problems.
Since that time, several studies have been published linking Avandia to congestive heart failure and other heart problems. Unfortunately, millions of Americans have already taken Avandia, and one expert estimates that thousands have suffered heart problems as a result.
Avandia Strokes
Avandia has been shown in studies to increase the risk of stroke. About 700,000 Americans each year suffer a stroke, and there are different types. The ischemic type is caused by a blocked blood vessel and the intracerebral hemorrhagic (ICH) type is caused by a ruptured blood vessel. More than 65% of people with diabetes die from heart disease or stroke.
In April of 2007 the US Food and Drug Administration (FDA) approved safety labeling revisions to advise of the increased risk for cardiovascular events associated with use of rosiglitazone male ate tablets in patients with New York Heart Association class 1 and 2 cardiac status; the risks for stroke, and deep vein thrombosis.
Diabetic patients with a family history of heart disease, cardiovascular disease, stroke, or congestive heart failure have a higher risk of these conditions when taking Avandia than no diabetic patients.
What is an Avandia Stroke?
A stroke is a type of cardiovascular disease. It affects the arteries leading to and within the brain. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts. When that happens, part of the brain cannot get the blood (and oxygen) it needs, so it starts to die.
