Two-Day Advisory Panel for the FDA Considers Lifting Restrictions on Avandia Sales in the US
In 2010, serious health concerns related to the use of Avandia forced the FDA to put strong warning labels on the drug. European pharmacies pulled the drug from shelves, and only about 3,000 people in the US currently take Avandia, despite concerns about stroke or heart disease.
However, an advisory panel for the FDA will meet for two days to reconsider Avandia and its restrictions, as some are saying that the diabetes drug is not as dangerous as once thought.
The FDA will spend two days reviewing a new interpretation of a study that evaluated Avandia’s heart attack and stroke risks, which suggests that the drug is as safe as older diabetes drugs. During the meeting this week, the FDA will take a usual step and ask a panel of experts to vote on a range of options for the drug, including lifting restrictions on use.
The debate about Avandia has cost manufacturer Glaxo billions of dollars and a tarnished reputation and has raged for three years. The latest in the argument is a positive safety review from Duke University.
Originally, Avandia was the top-selling diabetes pill in the world. It was approved in 1999, and by 2006 its’ total global sales had skyrocketed to $3.4 billion. The following year, however, an analysis of dozens of studies suggested that Avandia could seriously raise the risk of heart disease and heart attack in patients.
However, patients with Type 2 diabetes are already at an increased risk of heart disease, stroke, and heart attack, so for three years, a definitive answer to the question has never been reached.
Skepticism of Avandia Remains
The FDA panel is not without its critics. “You want to take a regulatory action because it’s going to benefit patients. I don’t see how patients could possibly benefit from lifting these regulatory restrictions,” said Dr. Steven Nissen of the Cleveland Clinic, who authored the 2007 analysis that first raised public safety concerns about Avandia.
Nissen and other critics suspect that the panel will meet simply to justify the FDA officials who struggled for years to keep Avandia on the market in the US. Because Nissen had authored one of the original analyses of Avandia, he offered to present at the meeting but was turned down.
The original Avandia study, called RECORD, followed 4,400 patients and tracked their rates of heart attack, heart disease, and stroke, as well as rates of hospitalization and heart-disease related death for six years. It is so far the lone major study to focus on Avandia’s side effects, and since 2009, when it was published, it raised many questions from a variety of experts.
The new study, however, cannot be considered independent – reportedly, Glaxo helped Duke finance the latest research.
“The re-adjudication was limited because it relies largely on the original database and source documents in collaboration with GSK,” said Dr. Thomas Marciniak, medical team leader of FDA’s Division of Cardiovascular and Renal Products.
Despite the suspicious funding, Glaxo has said that it has no plans to market Avandia again.
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Undergoing treatment for Congestive Heart Failure
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Avandia’s side effects can be mild or, in some cases, can even cause death. The way your body reacts to Avandia depends on a variety of factors – your overall health and medical history, for instance.
The pharmaceutical liability lawyers at The Strom Law Firm, LLC, are at the forefront of the fight to protect the public and will stand up for your rights against the big drug and insurance companies that produce dangerous drugs and products like Avandia. We will fight to ensure that you and your loved ones receive the justice you deserve. Contact our defective drug and wrongful death attorneys at the Strom Law Firm, LLC today for a free consultation to discuss the facts of your case as well as your legal rights. Contact us today. 803.252.4800.
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