by Linda G. Hull

Created on: March 26, 2009

Avandia, the popular Type 2 Diabetes drug, stands accused of heart related deaths and injuries, despite conflicting data. Lawsuits filed in the United States and Canada contend that pharmaceutical company, GlaxoSmithKline, failed to adequately test Avandia, or to warn of possible health risks and heart related deaths. Claimants say they misrepresented the drug as being safe.

About Avandia and GlaxoSmithKline:

Rosiglitazone maleate, more commonly known as Avandia, was created to treat Type 2 Diabetes in1999, by SmithKline Beecham, a pharmaceutical company based in the UK.

Avandia is used orally as an anti-diabetic agent. GlaxoSmithKline explains that Avandia increases insulin sensitivity which helps the body to use its own insulin. Avandia was approved for use by the U.S. Food and Drug Administration (FDA) in 1999, with Health Canada issuing its approval in 2001.

In 2000, SmithKline Beecham merged with Glaxo Wellcome to become GlaxoSmithKline, who continued the sale of Avandia, with milestone sales of over one million prescriptions in the U.S. recorded. Two years later, in 2002, sales increased to over 20 million prescriptions in the U.S.

Concerns about dangerous side effects surface:

In 1999, Dr. John Buse, a researcher with SmithKline Beecham, publicly brought to light his concerns of dangerous side effects from the use of Avandia, including an increased risk of heart attack. He addressed his concerns in a letter to the FDA in March, 2000. In 2001, the FDA issued a reprimand to GlaxoSmithKline for downplaying the risks to sales representatives and undercover investigators at a medical conference.

Dr. Stephen Nissen joined the chorus of concern in an article he wrote and published in the May, 2007, issue of the New England Journal of Medicine. It is available online at: < http://content.nejm.org/cgi/content/full/NEJMoa07276 1.

He concluded that Avandia needed more study to clarify risks of heart attack or congested heart failure, based on research data indicating that patients who took Avandia had a 43% higher risk for a heart attack. Public Citizen noted a decrease in Avandia usage after Dr. Nissen's article was published. The first lawsuit was filed in May, 2007, in the U.S. District Court for the District of Puerto Rico.

Finally in May, 2007, the FDA issued a safety warning for Avandia. Then, under increased pressure, the FDA issued its strongest warning, a "black box warning," in August, 2007, to note the increased risk of congestive heart failure, followed

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