FDA APPROVES DIABETES DRUG TESTED UNDER STRICTER GUIDELINES

May 1, 2011

The Food and Drug Administration recently approved a new drug to treat adults with type 2 diabetes. The manufacturers tested the drug under the FDA’s revised guidelines, ensuring that the new pill didn’t pose an increased risk of heart attack compared to existing approved treatments. The agency issued stricter guidelines in 2008, after post-market research proved that another diabetes drug, Avandia, was linked to an increased risk of heart attack.

Consumer advocates had complained that the FDA’s earlier standards protected the manufacturers of dangerous drugs. One unfortunate fact about diabetes helped the argument: Because the incidence of diabetes is on the rise — 7.1 percent of Oregon’s population in 2009, up two percentage points in 10 years — the number of people at risk is increasing as well.

Most drug manufacturers test their own products. The FDA is supposed to approve the tests or the protocols used. The revamped guidelines for diabetes drugs added the cardiovascular risk to the old, fairly simple requirement that tests show that the drug achieve its main objective: lowering blood sugar.

Not only did the revision call for a different study population, but it extended the testing period considerably. Manufacturers lost the argument that their costs would increase, and those increases would be passed on to consumers. For consumer advocates, the FDA had finally put patient safety first.

Diabetes affects the patient’s ability to break down carbohydrates. The resistance to the protein insulin puts them at greater risk of serious health issues, including heart attack, kidney problems and blindness. Type 2 is the most common form, affecting an estimated 95 percent of the 24 million Americans who suffer from diabetes.

Source: Huffington Post/AOL, “New Diabetes Drug Tradjenta Approved For Type 2 Diabetes,” Matthew Perrone, 05/ 2/11

 

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