The type 2 diabetes drug Avandia is linked to several side effects, including heart attacks. Over the years, the FDA has put restrictions on its use.
Avandia is GlaxoSmithKline’s trade name for the drug rosiglitazone, and was approved by the Food and Drug Administration (FDA) in 1999 for the treatment of Type 2 diabetes. Avandia is in the class of medications called thiazolidinediones, or glitazones, which includes Rezulin (troglitazone) and Actos (pioglitazone).
Glitazones are known as “insulin sensitizers” because they make type 2 diabetes patients more sensitive to insulin, helping them to better control and maintain safe glucose levels. Type 2 diabetes, which used to be known as adult-onset diabetes, is a condition in which the body either does not produce enough insulin, or cannot effectively use what it does produce. Insulin is a hormone made by the pancreas that enables the cells of the body to use sugar (glucose). In addition to a string of complications associated with diabetes, many who are diagnosed with Type 2 diabetes deal with the stigma attached to the disease.
Unfortunately, all three drugs in the thiazolidinedione family have had problems. Rezulin was recalled in 2000, after it was shown to cause liver damage, and Avandia use was severely restricted by the FDA in 2010 after it was linked to tens of thousands of heart attacks, strokes and heart failures. The FDA removed the restrictions in late 2013.
The third glitazone — Actos — has repeatedly been linked to an increased risk of heart failure and bladder cancer, but has not yet been recalled.
GlaxoSmithKline claimed its clinical trials of Avandia revealed only that the drug produced mild side effects, including upper respiratory tract infection, headache, back pain, hyperglycemia, fatigue and sinusitis.
In fact, in those clinical trials and in the many years since, Avandia was associated with a significant increase in the risk of myocardial infarction (heart attack).
Avandia’s Dangers Revealed
Avandia’s journey from clinical trials to FDA approval to restricted access is a long and complicated one.
|May 1999||Avandia is approved by the FDA for patients with type 2 diabetes.|
|Fall 1999||SmithKline Beecham completes a study of Avandia’s heart risks vs. those of Actos but buries the disappointing results.|
|December 2000||SmithKline Becham and Glaxo Wellcome merge to become GlaxoSmithKline (GSK)|
|April 2001||GSK commissions the RECORD study comparing cardiovascular outcomes of Avandia to other commonly used diabetes drugs. GSK reports that Avandia shows no heart risks, but critics ultimately find the study flawed.|
|June 2004||A legal settlement between GSK and the state of New York requires the drugmaker to post details about all of its clinical trials.|
|May 2007||Dr. Steven Nissen publishes study showing that Avandia increases heart attack risk by 43 percent. His peer-reviewed article appears in the June issue of the New England Journal of Medicine (NEJM). The FDA holds hearings on Avandia’s safety. (It is later revealed that Nissen was working for Takeda Pharmaceuticals — which manufacturers Avandia’s rival, Actos — when he issued this report.)|
|October 2007||A multidistrict litigation (MDL) is created in Pennsylvania to consolidate thousands of federal Avandia lawsuits against GSK.|
|November 2007||Following an advisory committee meeting, the FDA requires a black-box warning for Avandia stressing its link to congestive heart failure, while voting to allow it to stay on the market.|
|June 2008||Additional studies, including one published in the Journal of the American Medical Association (JAMA), conclude that Avandia poses health risks and should be pulled from the market.|
|February 2010||The U.S. Senate Finance Committee releases its report after two years of hearings, accusing GSK of intimidating physicians, suppressing critics and hiding negative data, while concurrently marketing Avandia aggressively.|
|May 2010||GSK settles more than 700 lawsuits out of court for approximately $60 million.|
|July 2010||FDA holds a second advisory committee meeting on the safety of Avandia. Members again vote to keep Avandia on the market. GSK settles another 10,000 lawsuits for approximately $460 million.|
|September 2010||The FDA restricts Avandia sales to those already taking it and to new patients who enroll in the Avandia-Rosiglitazone Medicines Access Program. Prescriptions can now only be received by mail. The European Medicines Agency withdraws Avandia from the European market.|
|February 2011||GSK avoids trial by agreeing to pay more than $250 million to resolve about 5,000 claims over Avandia’s health risks.|
|March 2012||GSK’s Avandia patent expires.|
|July 2012||As part of a $3 billion settlement, GSK pleads guilty to federal charges that it failed to report clinical data on Avandia.|
Avandia’s Side Effects
In addition to Avandia’s propensity to cause or exacerbate congestive heart failure, the drug also has several other serious side effects that warrant immediate medical intervention.
|Avandia’s serious side effects include:|
|Edema – swelling and weight gain due to the body’s retention of extra fluid||Shortness of breath|
|Fast or pounding heartbeat||Dark urine|
|Yellowing of the eyes or skin||Persistent nausea or vomiting|
|Abdominal pain||Bone fractures|
|Vision problems, including macular edema (eye disease with swelling in the back of the eye|
To date, tens of thousands of patients and their families have filed lawsuits against GlaxoSmithKline because of Avandia’s life-threatening complications. One estimate links the medication to as many as 100,000 heart attacks, strokes and heart failures, including many deaths.
Many Avandia lawsuits have been resolved through litigation, and Glaxo’s potential liability may exceed $6 billion. The company has also settled various civil suits relating to its manipulation of medical research concerning Avandia and its withholding of the drug’s safety data.
If you have taken Avandia and are experiencing any side effects from the medication, you may be liable for compensation for pain and suffering, loss of income and future medical costs. You are advised to contact a product liability attorney to find out if you can sue GlaxoSmithKline.