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After Long Debate, FDA Severely Restricts Use of Avandia in American Diabetics

By October 5, 2010July 17th, 2019Dangerous Drugs

The FDA has finally decided what to do about the serious heart risks to patients taking the diabetes drug Avandia (rosiglitazone). Given the increased danger of heart attack, stroke, and heart failure to 600,000 patients taking the drug, the FDA has severely restricted use of the drug, but it has not taken it off the market entirely. The European Union’s European Medicines Agency has forbidden the sale of the drug in the EU. In my view as a pharmaceutical liability attorney, the EU’s more cautious approach will probably protect more patients from serious harm. But I am glad that the FDA has at least restricted the harm that Avandia can do in the U.S.
The FDA has decided that use of Avandia can continue only for diabetics for whom other drugs have not worked. Most users will switch to different medications, and doctors will not be able to prescribe Avandia to new users without a detailed explanation of all the risks it entails. In addition, Avandia’s maker, GlaxoSmithKline, is not allowed to market the drug. Avandia had been the best selling diabetes drug in the world in 2006, when its sales reached $3.2 billion, but once news of its dangers spread, they dropped to $1.2 billion in 2009.
Those billions of dollars in sales clearly were important to GlaxoSmithKline, as the company tried to suppress evidence of Avandia’s problems and intimidate a cardiologist at Ohio’s Cleveland Clinic who first publicized problems with the drug. Dr. Steven Nissen’s 2007 study, published in the New England Journal of Medicine, showed that taking Avandia increased a patient’s heart attack risk by 64 percent, and Type 2 diabetes patients already are at high risk for heart attack. But GlaxoSmithKline insisted that Nissen was wrong, even though, as the U.S. Senate’s investigation discovered, GlaxoSmithKline’s own scientists privately acknowledged that Nissen’s study was sound.
Nissen’s research was central to Avandia’s restriction by the FDA, but he says that he wishes that the FDA had acted on it more quickly. “I will sleep better tonight, but I will not sleep until I know that we’ve have improved how we handle these kinds of problems in the United States. We’ve got to fix the FDA,” he said. An estimated 47,000 Avandia users suffered heart attacks, strokes, or heart failure between 1999 and 2009, a situation that Nissen described as “one of the worst drug safety tragedies in our lifetime. That’s why Nissen says it’s “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”
As a dangerous prescription medication lawyer, I’m glad that there will be fewer patients who have to suffer because of Avandia. But it would be better if no one else at all were to be harmed by this drug. Those who already have been hurt by it have strong reasons to consider seeking financial compensation from GlaxoSmithKline, as does anyone who has been hurt by a dangerous prescription or over-the-counter medication. Drug manufacturers have a legal responsibility to warn the public and the government about the harmful effects of their drugs, and from what we know of the Senate’s investigation, GlaxoSmithKline may have tried to do exactly the opposite. When a patient takes a medication about which the manufacturer has withheld important safety information, that drug maker can be held legally responsible for the harmful effects of its drugs.

Patients who are harmed by dangerous prescription drugs can work with a knowledgeable pharmaceutical liability lawyer who can advise them of their rights. Through a lawsuit, victims of defective medications can recover financial compensation for the expensive and exhausting medical treatments that ongoing cardiovascular problems and diabetes require, as well as past and future lost income and compensation for pain, suffering and lost quality of life. If you have been hurt by a dangerous prescription drug, please help yourself by calling the legal specialists at Carey, Danis & Lowe. We offer free consultations for patients and families in this situation. Please call us at 1-877-678-3400 or contact us through our website.