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Avandia Injury Lawyers
Baltimore, MD, Philadelphia, PA and Delaware
The Food and Drug Administration (FDA) has recently asked the makers of the Type 2 diabetes drug, Avandia (generic rosiglitazone), to carry a black-box warning, the most serious warning a prescribed drug can carry. Avandia is prescribed to control the blood sugar levels in people with Type 2 diabetes, which is also known as non-insulin dependent diabetes. Avandia first works by decreasing sugar production and then by helping the body make more efficient use of whatever insulin is available. Avandia has been associated with serious cardiovascular risks and cardiac-related death.
According to an article published in the New England Journal of Medicine on June 14, 2007, which was released early, on May 23, 2007, given the findings of a serious health risk to users of Avandia, taking Avandia significantly increases the risk of heart attack in diabetes patients; heart attack risk is increased by 43% and cardiac-related death by 64%. In response to this study, on May 21, 2007, the FDA issued a public safety alert, for immediate release, advising people taking Avandia to consult their doctors regarding cardiac risks associated with the drug.
Long History of Cardiac Risk
Avandia was approved by the FDA in 1999 to treat Type 2 diabetes, and it's been estimated that approximately six million people take this drug worldwide. Avandia is the world's top-selling diabetes drug with global sales exceeding $3 billion in 2006. However, concerns about Avandia and cardiac risks were made public as early as 2000 when Dr. John B. Buse, Chief of Endocrinology at the University of North Carolina at Chapel Hill, wrote a letter to the FDA warning that Avandia showed a "worrisome trend in cardiovascular deaths and severe adverse events" among patients taking the drug.
A year later, the FDA sent GlaxoSmithKline a letter stating the company's sales reps had minimized the drug's safety concerns. The FDA asked Glaxo to send a letter to healthcare professionals warning them of the serious risks involved with taking the diabetes drug. Even though Buse's letter to the FDA accused Glaxo of "pervasive and systemic" efforts to minimize the risks of the drug and overstate its benefits, no decisive action was taken to stop or even slow distribution of the drug.
Glaxo Defends Drug
GlaxoSmithKline, in response to the latest FDA request for a stricter warning label, issued a news release defending themselves and their top-selling drug. Glaxo is challenging the data presented in the NEJM stating it is much too soon to draw the conclusion that Avandia increases the risk of cardiovascular problems in Type 2 diabetes patients.
Attorneys for the drug giant state they are already getting calls from Avandia users and predict future lawsuits in the tens of billions of dollars.
Glaxo Chief Executive, Jean-Pierre Garnier, has said it's much too early to tell if Avandia will be the subject of future lawsuits; he is confident of the safety and efficacy of Avandia.
If you or a loved one in Pennsylvania, Maryland or Delaware has taken Avandia and suffered adverse cardiovascular side effects, please call or email us today to speak with one of our pharmaceutical injury lawyers.
