FDA Dramatically Curtails Availability of Avandia After Studies Show Heart Risks

By May 23, 2011 July 18th, 2019 Dangerous Drugs

Our law firm has kept an eye on reports about the diabetes drug Avandia (rosiglitazone) and its relatives for several years, since studies began connecting them to a significantly increased risk of heart attacks. So as a dangerous drug attorney, I was very pleased to see the FDA’s announcement last week that it would sharply limit patients’ access to Avandia because of its cardiovascular risks. According to a May 19 article from HealthDay News, the FDA will no longer allow retail pharmacy sale of Avandia starting in November. Instead, patients taking Avandia will have to enroll in a special program qualifying them to receive it by mail-order. Echoing a previous safety decision, the FDA will limit the pool of people eligible for a prescription and require them to acknowledge receiving information about the risks.
Avandia has been in trouble since at least 2007, when an analysis of multiple studies concluded that patients’ risk of a heart attack could be as much as 43 percent higher when taking the drug. It has also been linked to increased risk of stroke and other cardiovascular problems. To make matters worse, the drug’s maker, GlaxoSmithKline, has been accused in Congress of intentionally suppressing information about the risks. In 2010, the FDA moved to restrict Avandia’s sale to only those patients who had the risks explained to them and agreed in writing that they understood. However, the new move restricting Avandia to mail-order pharmacies is expected to make the drug very rarely prescribed. Dr. Steven Nissen, the author of the 2007 meta-study, told HealthDay that “It’s like a decade-long nightmare coming to an end” because “virtually no one will be able to get it.”
As a defective drug lawyer, I agree with Nissen that this is great news for patient safety. The results of independent studies on Avandia have not been mixed; several studies have found results similar to Nissen’s. In fact, the drug is already banned in the European Union and New Zealand for safety reasons. And the manufacturer has already settled thousands of Avandia injury lawsuits. However, I also agree with safety advocates that this action by the FDA comes too late and more slowly than it should have, given the elevated risk of death from taking Avandia. As HealthDay pointed out, the other drug in the same class, Actos (pioglitazone), doesn’t show nearly the same heart health risks, making it a safer alternative. With an alternative clearly available, it’s disappointing that the FDA is taking 14 months between deciding Avandia is unsafe and curtailing its availability.


At Carey, Danis & Lowe, we focus our practice on helping patients who were seriously injured or sickened because of a drug they thought they could trust. We also represent the families of patients who died after taking an unsafe drug. In all of these cases, the defective drug can cause personal and financial havoc, sending the patient to the hospital and incurring huge medical and funeral bills they can’t afford to pay, especially if the patient is losing time at work. Our pharmaceutical liability attorneys return these costs to the party that caused them: the drug company that made an unsafe drug, then hid safety information from patients. In a lawsuit, patients can win back all of the costs of the injury, including lost wages, as well as compensation for their pain, suffering and losses.
If you or someone you love was seriously hurt by a defective prescription drug, don’t hesitate to call Carey, Danis & Lowe to tell us about your case. To learn more, send us an email or call 1-877-678-3400.