Life After Avandia: New Diabetes Drugs Will Face Tougher Testing for Heart-Failure Risks
In the wake of widespread reports of heart failures, liver damage, and other patient injuries and seemingly non-stop controversy surrounding the top-selling type-2 diabetes drug Avandia, the Food and Drug Administration now says that future diabetes drugs will face much tougher scrutiny.
More extensive and longer pre-marketing testing of diabetes drugs will now be required for FDA approval in an effort to ensure that the medications do not carry the same increased risks of life-threatening complications as Avandia. The more rigorous testing is expected to make the development and testing of new diabetes drugs more expensive and take more time to get them to market.
Avandia (rosiglitazone maleate) was approved by the FDA in 1999 and has been taken by millions of people with type-2 diabetes in the United States. Avandia helps control blood-sugar levels in diabetics by making body cells more sensitive to insulin, but the drug has been blamed for dramatically increasing the risks of congestive heart failure, liver damage, and other deadly side effects.
Diabetes: A United States Epidemic
Type 2 diabetes, also called adult-onset diabetes, is considered an epidemic in the United States, affecting an estimated 23 million people, including about 6.5 million children. The condition leaves the body either unable to produce enough insulin or resistant to insulin.
Studies have shown that over time, patients taking Avandia to treat their diabetes are between 43 and 64 percent more likely to suffer a fatal heart attack, kidney failure, blindness, and other serious complications.
Avandia has been the target of repeated FDA actions in recent years. In May 2007, the agency issued a public health warning to warn Avandia users about the increased risks of heart and liver failure associated with the drug. Then, in 2008, the FDA ordered Avandia’s makers to include a prominent “Black Box” warning on the product’s packaging to further warn physicians and patients of the dangers.
Raising the Bar for FDA Approvals
The FDA hopes that by raising the bar for approvals of new type-2 diabetes drugs, long-term problems such as those now linked to Avandia can be detected in pre-marketing testing and development before the drugs are prescribed to patients.
Under the new FDA rules, drug companies will be required to establish independent committees to monitor diabetes drugs under development for rates of heart attacks, strokes, and other heart-related deaths and hospitalizations. The companies will also have to conduct detailed statistical analyses of the rate of complications and fall below an acceptable level set by the FDA.
Drug companies commonly conduct testing of new medications on people who are younger and healthier than the patients for whom the drug is designed, but the new FDA policy will force drug companies to test drugs on greater numbers of high-risk patients, such as the elderly and people with relatively advanced diabetes and kidney problems.
The makers of about 150 medications currently under development have already been notified of the new and stricter FDA rules for new-drug approvals, officials said.
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