Avandia - Side Effects and Avandia Problems

Avandia (rosiglitazone maleate), approved by the FDA in 1999, is used to treat Type 2 diabetes, a serious condition affecting approximately 20 million Americans. GlaxoSmithKline manufactures the drug prescribed for diabetes, a leading cause of coronary heart disease, blindness, kidney failure as well as limb amputation.

FDA NEWS UPDATE FOR AVANDIA: February 6 , 2008

 

The government announced Wednesday that the 10,000 patient ACCORD clinical trial involving diabetes treatment has been halted 18 months early due to increased risk of patients death. The trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%.

Although the research does not indicate a link between Avandia use and increased deaths, Steve Nissen, who linked Avandia use to increased risk of heart attacks, states, “ "It's very hard to sort out," and "We've got to be careful not to jump to conclusions.". Nissen went on to say "Clinicians have been taught that getting to lower blood sugar is better” and “its really going to shake things up”.

 

FDA NEWS UPDATE FOR AVANDIA: November 15, 2007

Avandia (rosiglitazone maleate) Tablets

Audience: Cardiologists, endocrinologists, other healthcare professionals, consumers
[Posted 11/14/2007] FDA informed healthcare professionals of new information added to the existing boxed warning in Avandia's prescribing information about potential increased risk for heart attacks. The new information refers to a meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, that showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk to their healthcare professional about the revised warning as they evaluate treatment options. Healthcare professionals are advised to closely monitor patients who take Avandia for cardiovascular risks.

SOURCE: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Avandia2

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In May 2007, the New England Journal of Medicine published a report linking the drug to a significant increase of heart attack risk and heart-related death.  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.

Why is Avandia Prescribed

For patients with Type 2 diabetes, Avandia, along with diet and exercise, lowers blood sugar and can help keep it under control. Avandia can be taken alone or with other diabetes medicines. Many people need to take more than one medicine to help treat diabetes in different ways. Avandia is also available in combination with other diabetes medicines including Avandamet and Avandaryl.

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FDA Approved Uses for Avandia

Avandia, part of a newer class of diabetes drugs called thiazolidinediones or glitazones, increases the body's sensitivity to insulin. The FDA approved Avandia on May 25, 1999 to treat Type 2 diabetes.

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Avandia Side Effects

Possible side-effects caused by patients taking Avandia include congestive heart failure, edema, and fluid retention, liver toxicity and low blood pressure.  Yellowing of the skin and dark urine are signs of liver disease which can be caused by Avandia.

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Avandia Warnings and Alerts

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 deaths than those taking a placebo or other diabetes drugs. As of May 2007, the FDA said data analyses were ongoing to confirm the risks. Doctors also recommend checking eye sight while taking Avandia as it is reported to cause vision changes.

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Avandia Drug Contraindications

Avandia may increase risk of pregnancy. Women nursing infants should not take Avandia. More fractures, usually in the upper arm, hand, or foot, have been seen in women taking Avandia. Patients with type 1 diabetes, or in patients who have experienced yellowing of the skin (jaundice) from taking other types of diabetes mellitus medications should not take Avandia. Also, patients with a history of heart failure, kidney disease or ketoacidosis should refrain from taking the drug.

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FAQ's on Avandia

If I suffered a heart attack while taking Avandia, can I sue GlaxoSmithKline?

Possibly, yes.  GlaxoSmithKline has made billions of dollars in profits from Avandia, one of the most popular diabetes drugs in the world. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability." To discuss potential litigation regarding your Avandia case, contact our attorneys at 1-800-819-1000 and ask to speak to a Case Intake Specialist

I am taking Avandia for my diabetes; should I stop?

Not necessarily. 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 immediately about this new information to evaluate alternate treatment options for their type 2 diabetes.  There are other drugs that can be used to treat your condition, but only your doctor will know which one is right for you.

The FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Changing or stopping diabetes medications can cause serious health problems and should be considered carefully with your health care provider.  In light of the latest information, each patient should make an informed, individualized decision after thorough consultation with his or her doctor.

Does Avandia cause heart attacks?

Possibly.  While there are no confirmed findings of Avandia causing heart attacks, the FDA reports patients receiving short-term treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy.  Because two-thirds of patients with Type 2 diabetes die from heart problems, any drug that increases this risk may lead to fatal heart conditions.

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