After much controversy, the U.S. Food and Drug Administration finally tell Avandia it's a wrap.
It's been a long time coming, but finally the U.S. Food and Drug Administration (FDA) has announced that starting in November, GlaxoSmithKline's controversial yet popular diabetes drug Avandia will no longer be sold in pharmacies in the United States because a past study found that people who took the drug had a higher chance of having a heart attack.
This doesn't mean that the drug is banished forever though. According to the new rules, the medication will only be available to people who've been safely using the drug in the past; those who have tried other diabetes meds and they haven’t worked for them; or patients who have been informed of the risks and still want to take Avandia. But the FDA is clear: These patients must be enrolled in a special program to qualify to receive the drug.
The pulling of Avandia was no accident—health advocates, researchers and doctors spoke out against the drug, and their advocacy worked. Just eight months ago, the FDA put a severe crackdown on the drug and told doctors that they could only prescribe the drug to patients who had tried other diabetes medications, with bad results.
The main "whistle blower" on Avandia was Steven Nissen, M.D., the chief of cardiovascular medicine at the Cleveland Clinic. After conducting a study in 2007 and finding that people living with type-2 diabetes had a 40 percent increase in heart attack risk, Nissen urged the FDA to ban the drug. Other researchers who conducted their own studies had similar findings.
"It's like a decade-long nightmare coming to an end," Nissen, told USA Today. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."
Avandia was once the world’s best-selling diabetes brought in $3 billion in annual revenue, generated $680 million in sales last year. In America alone, it is estimated that there are over 23 million people living with type-2 diabetes and more than half of those people were on some version of the generic version of Avandia. The FDA estimates between the months of January to October in 2010 about 460,500 patients filled a prescription for Avandia.
This news is especially relevant to us, because we disproportionately suffer from diabetes. It's estimated that 15 percent of all African-Americans who are 20 and older have diabetes; 25 percent of African-Americans between the ages of 65 and 74 have diabetes; and 25 percent of African-American women over 55 have diabetes.
If you have a loved one who has type-2 diabetes, please talk to them about which drugs they are taking; if they are taking Avandia, make sure that their doctor has spoken to them about the risks.
(Photo: REUTERS/Lucy Nicholson/Landov)