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Avandia Dangers May Lead to Potential FDA Recall

A battle that has been brewing for years over adverse side effects of a popular type 2 diabetes drug, Avandia (rosiglitazone), has prompted yet another debate among
Food and Drug Administration (FDA) officials. This comes
after an article published in The New York Times on February 19, 2010, revealed disturbing information found in confidential government reports recommending the drug be removed from the market.

According to the documents, hundreds of individuals taking Avandia unnecessarily suffer heart failure each month. In fact, Avandia was linked to 304 deaths in the third quarter of 2009. An Avandia recall may be on the horizon following an FDA announcement that the agency is currently reviewing data submitted in August 2009 from a large, long-term analysis known as the RECORD study and several observational studies linking Avandia dangers to potentially fatal side effects. The FDA is expected to announce its findings and further action at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

In the meantime, Avandia maker GlaxoSmithKline PLC could be facing up to $6 billion in personal injury lawsuits following an internal investigation by the U.S. Senate Finance Committee concluding that GlaxoSmithKline minimized the drug's safety risks by withholding essential data from both the FDA and the public.

Despite the controversy and possible life-threatening Avandia side effects, the FDA has decided not to pull the drug from the market until it fully understands the scope of the health risks associated with the medication. However, the agency has released an Avandia FDA alert stressing the importance of adhering to the recommendations on the drug label. Type 2 diabetes patients currently on Avandia are being asked to consult their healthcare provider about the possible risks associated with the drug but not to discontinue its use without medical advice.

Consulting a Qualified Defective Drug Attorney

If you or a loved one is an Avandia heart attack victim or has experienced a similar side effect associated with this drug, you may be eligible to receive compensation for your medical bills, pain and suffering. Please contact one of the experienced Avandia lawyers of Viles & Beckman, LLC at 1-800-689-1094 for expert legal advice.

Page Updated March 17, 2010

Previous FDA Warnings Type 2 Diabetes Allergic Reactions Heart Attack

    Previous Avandia FDA Warnings

  • This is not the first time that Avandia has been under FDA scrutiny. In May 2007, a study by Cleveland Clinic cardiologist Dr. Steve Nissen showed a 43 percent increase in heart attack risk for Avandia patients. The results were based on 42 prior clinical trials involving nearly 30,000 participants.
  • Although this data was deemed inconclusive, government officials released several Avandia FDA warnings and demanded the following from the manufacturer:
  • A new boxed warning about the potential increased risk of myocardial ischemia
    Changes to the current warnings, precautions and indications sections of the label
    A medication guide for patients
    Recommendations and considerations for healthcare professionals
    Additional studies by GlaxoSmithKline examining cardiovascular risks
  • The FDA also sought independent expert advice, which concluded that Avandia treatment might increase the risk of heart attack but recommended that the drug remain on the market. An FDA oversight board voted eight to seven to accept the advice.
  • According to the American Diabetes Association, 23.6 million Americans suffer from type 2 diabetes (also referred to as type II diabetes). This serious medical condition affects how the body metabolizes sugar (glucose). Individuals who suffer from type 2 diabetes are resistant to insulin, which is a hormone produced by the pancreas to control and distribute sugar throughout the body. In some patients, the pancreas fails to produce enough insulin to maintain a normal glucose level. Type II diabetes is a devastating illness associated with a number of life-threatening complications.
  • Although type 2 diabetes cannot be cured, there are several treatment options to prevent further complications. Most type 2 diabetes treatments focus on maintaining a near-normal level of glucose in the blood and/or assisting the body in absorbing naturally produced insulin. Diabetes treatment with Avandia has been one of the treatments most frequently utilized by physicians worldwide. In addition to Avandia treatment, most patients require a combination of different types of drugs in conjunction with a healthy diet, weight loss and physical activity. Insulin therapy may also be appropriate for patients who do not respond well to the above treatments. However, Avandia treatment for diabetes is not recommended in conjunction with insulin.
  • Read more about Avandia and Type 2 Diabetes
  • An allergic reaction is the body's way of responding to a foreign substance. When the immune system is triggered in an attempt to protect the body, a hypersensitivity reaction (allergic reaction) occurs. According to the Allergy Foundation of America (AAFA), approximately 17 million individuals visit a physician due to allergic reactions each year. In rare cases, an allergic reaction can be life-threatening.
  • Although allergic reactions occur for various reasons, many are a result of a chemical substance in the body, including medication. Avandia, a type 2 diabetes drug, is known to cause allergic reactions in some individuals.
  • If you recognize the following symptoms and are taking Avandia treatment, please consult your physician immediately:
  • Skin rash
    Hives
    Itching
    Wheezing/trouble breathing
    Unexplained swelling
  • Read more about Avandia Alergic Reactions
  • In February 2010, an Avandia FDA warning was released informing consumers and healthcare providers that it is now reviewing the primary data from a major study, known as the RECORD study, linking the type 2 diabetes drug Avandia to an increased risk of life-threatening side effects, including heat attack, stroke and death. The alert came shortly following an article in The New York Times revealing confidential government documents recommending an immediate recall for Avandia treatment.
  • For several years, the FDA has been working to determine whether Avandia should remain on the market and whether the drug increases the risk of heart failure and other fatal cardiovascular events as suggested by a number of clinical trials, which have been ruled inconclusive.

    Read more about Avadia Heart Attack

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