Avandia side effects increase the risk of heart problems

By Austin Kirk
Posted May 21, 2007

ADD YOUR COMMENTS 1

According to an article in next months issue of the New England Journal of Medicine, Avandia side effects significantly increase the risk of heart attacks and heart related death.  While many are drawing comparisons to Vioxx, which was removed from the market nearly three years ago after the same researcher reported an increased risk of heart problems, there is no indication at this time that there will be an Avandia recall.  The FDA intends to review this information and will convene an advisory committee to determine whether steps should be taken to protect consumers. 

>>INFORMATION: Avendia side effects safety alert from FDA

Avandia (generic rosiglitazone) is a medication used to treat Type-2 diabetes.  There are 21 million diabetics in the United States, and 95% have type two diabetes  The condition is associated with an increased risk of heart disease, kidney failure and other serious complications.  

The Avandia study was released on the New England Journal of Medicine website today, in advance of the intended publication date of June 14.  The researchers looked at data from 42 clinical trials involving nearly 28,000 people.  The analysis found that those taking Avandia had a 43% increase in the risk of a heart attack and 64% increase in the risk of heart related death when compared to those taking another drug or a placebo.

Over 6 million people worldwide have taken Avandia and it generated $3.2 billion in sales last year for the manufacturer, GlaxoSmithKline PLC.   Many have questioned why the FDA and drug manufacturer have not taken actions to protect the public from this risk.  A congressional committee has been scheduled regarding the drug’s safety to determine what they knew and  when they knew it.  Although the manufacturer has publicly disputed the analysis in defense of their blockbuster drug, they have previously acknowledged that their own review found a 30% increased risk.

The Avandia problems are especially troubling since 65% of all people with diabetes eventually die from heart disease.  An editorial which accompanied the study questioned the rationale for the continued prescription of the drug since the risk of Avandia heart problems could outweigh any benefit the diabetes medication provides.  The FDA, as well as the researchers who published the study, have recommended that any individuals concerned about Avandia side effects should consult with their physicians.  No medication should be stopped or changed without speaking with a doctor first.

The lawyers at Saiontz & Kirk, P.A. are closely monitoring the research and will post further information regarding the potential for Avandia lawsuits as it becomes available.  To receive updates by email click here, or you can follow our RSS feed.  If you, a friend or family member have suffered Avandia side effects, and wish to have your potential claim reviewed by one of our lawyers, request a free consultation.