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FDA Panel Calls for Tougher Safety Standards on Diabetes Drugs

Posted by Chrissie Cole
Thursday, July 03, 2008 4:51 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Heart Attack, Diabetes, Insulin, Heart Disease, Avandia, Rosiglitazone


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Government advisers recommend type 2 diabetes drugs face tougher safety standards to ensure they don’t increase the risk of heart related problems, following research conducted by a prominent Cleveland Clinic cardiologist.

Advisers to the Food and Drug Administration (FDA) voted 14-2, that all new diabetes drugs should withstand longer cardiovascular trials to assure they don’t increase risk of heart problems.

At present, the agency doesn’t screen for heart risks associated with diabetes drugs.

Advisers said trials assessing cardiovascular risk should be done before a drug is submitted to the FDA for approval; as part of a phase III trial to rule out any significant heart risk and then studies can be finished after the drug is on the market.

The testing should last on average five years to complete and is likely to cost millions of dollars.

At this time, the only requirement the FDA poses on drugmakers of type 2 diabetes medications is that they lower blood sugar, which helps to protect diabetics who suffer from debilitating side effects of the disease.

While the FDA is not required to follow all recommendations made by the advisory panel, in most cases they do.

A new report by the U.S. Centers for Disease Control and Prevention shows approximately 24 million Americans are afflicted with diabetes, a staggering increase of 15 percent in two years.

Diabetes is the seventh-leading cause of death in the United States.

It was less than a year ago that the FDA came under fire for how it approves diabetes medications after an analysis authored by a Cleveland Clinic cardiologist suggested GlaxoSmithKline’s drug, Avandia increased patients’ risk of heart attack.

On May 21, 2007, the New England Journal of Medicine released a Research Article entitled, “Effect of Rosiglitazone on the Risk of Mycardial Infarction and Death from Cardiovascular Causes” in which authors Steven E. Nissen, MD and Kathy Wolski, MPH concluded,

"Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance."

Nissen and Wolski evaluated 42 studies involving nearly 28,000 patients and compared the 15,560 patients who were using Avandia to the patients who were not using the drug. They found 86 myocardial infarctions in the and 72 in the control group, and there were 39 deaths from cardiovascular causes in Avandia patients compared to 22 in the control group.

Avandia was approved in 1999. The FDA requested a black box warning about the increased risk of heart attack in November 2007. The agency made the decision to keep the drug on the market after concluding the inherent risk of heart attack wasn’t any greater than that associated with other similar medications.

On Tuesday, Nissen conveyed to advisers, the need for companies to provide adequate evidence that shows their type 2 diabetes drugs do not increase the risk of heart disease prior to drug approval.

“Merely lowering blood-glucose levels in diabetes is too simplistic," Dr. Nissen told the panel. "We must reduce the complications of diabetes, including cardiovascular disease."

If the agency adopts the panel’s recommendations, the additional clinical trials could add years and millions of dollars to the development of new type 2 diabetes drugs. #


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