The U.S. Food and Drugs Administration (FDA) has restricted the use of the controversial diabetes drug Avandia (rosiglitazone) due to its propensity to increase cardiovascular disease risk.
From now to prescribe the drug, physicians will now have to be part of a registry that certifies they are familiar with the heart risks associated with Avandia, and that they are prescribing it only because their patients have exhausted all other medications to help control their blood sugar. Patients already on the drug will now be contacted to discuss the new regulations and the option of switching to another medication. Use of two other diabetes drugs - Avandamet and Avandaryl - will also be restricted as both contain rosiglitazone.
Avandia is a popular drug which grossed nearly $3 billion worldwide during its peak of popularity in the early 2000s. Dr. Steven Nissen, a cardiologist at Cleveland Clinic who first documented the 20 to 40% increased heart attack rate associated with the drug in 2007 said, “Just the paperwork requirement is too daunting to put people on this drug…If all you have to do is pull out a prescription pad for an alternative drug, what do you think the doctor is going to do? I think the drug is effectively gone.”
In July, an FDA panel of outside experts voted against banning Avandia, leaving many to wonder why a drug that seems to raise the risk of heart problems should continue to be a treatment option.
The EU has also done away with the drug. One of the alternatives that are considered safer is pioglitazone, or Actos, which belongs to the same class of medications as Avandia. The European Medicines Agency emphasized on the benefits that a drug like Avandia provides and suggests alternatives.
According to FDA's Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, “the cardiovascular safety profile of rosiglitazone is still an open question because there are conflicting data on the existence and magnitude of the risk.”
In the initial studies that assessed the risk of the drug experts, including Nissen and even FDA scientists say the company sponsored studies were flawed and minimized the heart risks. Dr. Allison Goldfine, head of the section on clinical research at Joslin Diabetes Center and a member of the panel that voted to keep Avandia on the market said, “There were a lot of questions raised about how to interpret the data, and there was a tremendous amount of uncertainty.”
Sales of the medication began dropping after Nissen's paper was published and the FDA issued its first warning, advising patients with a history of heart disease from taking the drug. Says Nissen, “I find it hard to imagine that even a single patient can't take any of the other diabetes drugs. Nobody should essentially get this drug.”
Dr. Ellen Strahlman, of GSK said, “Our primary continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.”
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