Avandia Injury Lawyers
Baltimore, Maryland and Delaware Avandia Claims Attorneys
In June 2007, the Food and Drug Administration (FDA) asked the makers of the Type 2 diabetes drug, rosiglitazone, marketed primarily as Avandia, but also as Avandamet and Avandaryl, to carry a black-box warning, the most serious warning a prescribed drug can carry. In August 2007, GlaxoSmithKline agreed to a warning describing the risk of serious cardiac injury following Avandia use.
If you are an Avandia user in Maryland or Delaware who suffered cardiac injury as a result of this dangerous drug, you may be able to recover damages. The pharmaceutical liability lawyers at the Law Offices of Peter G. Angelos, PC can help you stand up to the pharmaceutical giant that may have known about the risks and played them down. Contact us today for a free consultation.
Avandia and Its Risks
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 (NEJM) 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 has been estimated that approximately six million people take this drug worldwide. Avandia was a 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 2007 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. GlaxoSmithKline included the dispute about the extent of cardiac risk in the Avandia black box warning.
The March 4, 2009, Supreme Court ruling in Wyeth v. Levine reasserted a drug company's responsibility to proactively identify dangers associated with their product and work to warn users about these possible risks. We believe that the evidence will establish that GlaxoSmithKline has done the opposite, fighting attempts to warn patients and potentially encouraging its sales representatives to conceal risks. A report released in February, 2010 on Avandia by staff of the Senate Finance Committee (January 2010) reaches the same conclusions regarding GlaxoSmithKline’s early knowledge of Avandia’s cardiac risk and concealment.