Nov. 25--Avandia, a controversial diabetes drug that was thought to increase
patients' risk of heart attacks and other cardiovascular problems, has been
cleared for widespread use by the Food and Drug Administration.
Federal regulators said Monday that the drug was no more dangerous than other
diabetes medications and that it should be available to all patients without its
"Our actions today reflect the most current scientific knowledge about the risks
and benefits of this drug," Dr. Janet Woodcock, director of the FDA's Center for
Drug Evaluation and Research, said in a statement. "Given these new results, our
level of concern is considerably reduced."
GlaxoSmithKline, the company that makes Avandia, said it welcomed the FDA's
"GSK maintains its view that Avandia is a safe and effective treatment for Type
2 diabetes when used appropriately," the London-based company said in a
Avandia used to be the top-selling drug for patients with Type 2 diabetes, a
disease that causes people to lose their ability to metabolize blood sugar with
insulin. Unlike other drugs that help patients produce more insulin, Avandia
works by making cells more sensitive to insulin, allowing the body to use it
The drug, whose generic name is rosiglitazone, came on the market in 1999 and
had more than 1 million users in 2006. But in 2007, cardiologists warned that
patients taking Avandia were more likely to have serious heart problems than
patients taking other diabetes drugs.
A study led by Dr. Steven Nissen of the Cleveland Clinic linked Avandia to a 43%
increased risk of having a heart attack and a 64% increased risk of death due to
heart disease. The findings, based on data pooled from 42 small clinical trials,
were published in the prestigious New England Journal of Medicine.
Those results prompted some experts to question how well the FDA was monitoring
the safety of prescription drugs. Just a few years earlier, the federal agency
withdrew its approval of the painkiller Vioxx after it evidence emerged that it
doubled the risk of heart attacks and strokes. When the critique of Avandia
emerged, three major congressional committees announced their intention to
The FDA responded by adding warning labels to Avandia.
After further study, the agency said in 2010 that patients taking Avandia were
30% to 40% more likely to develop a condition called myocardial ischemia, which
decreases blood flow to the heart. Those who were also taking insulin or drugs
to control their blood pressure faced a greater risk, the scientists said.
Regulators imposed a host of restrictions on the drug. New prescriptions could
be written only for patients who could not control their blood sugar with other
medications, including Avandia's main rival Actos. Patients who were already
taking Avandia were required to sign an informed consent statement acknowledging
that they are aware of the drug's heart risks. Regulators in Europe pulled it
off the shelves altogether.
Today, only about 3,000 Americans still take Avandia, and they are closely
monitored by the FDA and GlaxoSmithKline.
A new analysis this year by an FDA advisory panel suggested the initial concerns
about Avandia were overblown. Members of the panel pointed to design flaws in
Nissen's study and said their evaluation found no evidence that the drug made
patients more vulnerable to heart attacks or other heart problems.
The initial "signal of increased risk of heart attacks" reported by Nissen in
2007 has not been confirmed, the FDA said in the statement released Monday.
As a result, the FDA will no longer require doctors to limit Avandia
prescriptions to certain patients. Its new label will likely state that anyone
with Type 2 diabetes can use the drug in combination with diet and exercise to
control their blood sugar, the agency said.
Patients who take Avandia will no longer be required to participate in a
tracking program, and they'll be able to get the drug through regular
The FDA also said it would no longer require GlaxoSmithKline to conduct a
clinical trial comparing Avandia to Actos and to other diabetes drugs.
Monday's vote of confidence from regulators won't be enough to rehabilitate
Avandia's poor reputation among physicians, experts said.
"I don't believe people are going to flock back to it," said Dr. Karol Watson, a
cardiologist and co-director of UCLA's Program in Preventive Cardiology.
"People just weren't prescribing it because there were a lot of other
alternatives that could do the same thing and without the hassle," she said,
adding that new diabetes drugs have been developed since Avandia's troubles
Gerald van Belle, a clinical trial expert who served on the FDA advisory panel,
urged the agency in June to keep the restrictions on Avandia in place. On
Monday, he reiterated his concerns about making the drug widely available.
"Since this is a safety issue, I think it pays to be cautious," said Van Belle,
a professor of biostatistics at the University of Washington in Seattle.
"There were two new observational studies that suggested risk, as before," he
said. Without clinical trials that unequivocally demonstrate Avandia's safety,
the drug's use should continue to be highly restricted, he added.
Avandia is also sold in combination with the diabetes drugs metformin and
glimepiride under the brand names Avandamet and Avandaryl. Restrictions on those
drugs will be lifted as well, the FDA said.
Times staff writers Monte Morin and Melissa Healy contributed to this report.
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