Avandia, a popular diabetes medication, has been linked to an increased risk of serious and potentially deadly side effects. Some of the conditions associated with the use of Avandia include:
- Liver toxicity
- Low blood pressure
- Heart attack
- Congestive heart failure
- Fatal heart issues
Avandia (generic: rosiglitazone) is a drug manufactured by GlaxoSmithKline to treat Type 2 diabetes. The United States faces an epidemic of nearly 21 million diabetes sufferers, making diabetes one of the most lucrative diseases for pharmaceutical companies. Since GlaxoSmithKline (GSK) introduced Avandia in 1999, about half of America’s diabetes patients have been prescribed Avandia. Unfortunately, because of the dangers associated with Avandia, this has placed the health of a large number of people at great risk.
Research Against Avandia
From the onset, Avandia was known to have possible risks of liver toxicity and low blood pressure. The first research linking Avandia to additional adverse side effects was published in 2007 in the New England Journal of Medicine. The study found that Avandia increased the risk of heart attack by 43% and of fatal cardiovascular event by 64%.
The Food and Drug Administration (FDA) released a black box warning in May 2007 stating that GlaxoSmithKline provided them with research showing a 30-40% greater risk of heart attack for Avandia users than those not taking the drug. The warning is the severest of those issued by the FDA, and it was of crucial importance to patients with an already-increased risk of heart disease.
In February 2010, a bi-partisan Senate report spoke out against Avandia, blaming both GlaxoSmithKline and the FDA for tens of thousands of heart attacks. The report suggests that both the drug manufacturer and the FDA knew about the risks associated with Avandia for years prior to the 2007 safety alert being issued and did not warn patients and doctors as they legally and ethically should have.
The latest research into Avandia’s adverse side effects compared it to a competing diabetes drug, Actos. This study was published in the British Medical Journal in March 2011 and indicated startlingly high statistics for risk including
- 23% higher risk of congestive heart failure
- 16% higher risk of heart attack
- 14% higher risk of death
To put the study’s results into perspective, it shows that for every 100,000 patients taking Avandia instead of Actos, there would be 431 more deaths, 649 more cases of heart failure and 170 more heart attacks.
FDA Takes Action
In September 2010, drug regulators in the United States and Europe announced that Avandia would no longer be widely available. Avandia sales were completely banned in Europe. The diabetes drug is still available in the U.S. to patients who have exhausted all other options for treatment and who are aware of the drug’s significant risks to the heart. Doctors should not prescribe Avandia to anyone with a history of cardiovascular problems.
Many groups have called for the full removal of Avandia from the market. Public Citizen, a consumer advocacy group, has asked the FDA to ban the diabetes drug due to the cardiovascular risks as well as 14 cases of liver failure in Avandia users discovered by the group. 12 of the liver failures proved fatal. The American Diabetes Association and the European Associate for the Study of Diabetes said that a joint medical panel “unanimously advised against using” Avandia.
An estimate of 13,000 Avandia lawsuits are pending or have been filed against GSK in the United States and that number continues to rise. In 2010, a large number of these lawsuits were settled, including a group for $60 million and another group for $460 million, according to Bloomberg News. GlaxoSmithKline has reportedly allocated special funds for pending and future lawsuits that are likely to continue while Avandia remains on the market. Based on the vast number of people who have been prescribed Avandia, it is likely that thousands of patients have suffered adverse Avandia side effects such as heart attack.
What You Can Do
If you or a loved one has suffered serious injury or death as a result of Avandia usage, contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.