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Published on 22 December 2008

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Diabetes drugs face tougher tests

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New drugs under development for the treatment of diabetes are to face more stringent tests in the US in order to check for potential heart risks, the country’s health watchdog has announced.

The Food and Drug Administration (FDA) said its policy change should offer a greater assurance of safety to doctors and patients.

Diabetes is seen as reaching epidemic levels in America, with 23 million people testing positive for the type 2 form of the condition. People with diabetes are at higher risk of heart attacks, kidney problems, blindness and other serious complications.

As heart attacks are a leading cause of death among diabetics, it is feared medications that increase heart risks could be a case of the cure being worse than the disease.

That is particularly true when other treatments are available that do not appear to have heart risks, such as insulin injections or drugs like metformin.

Dr Mary Parks, head of the FDA division that oversees diabetes drugs, said: “The more we know about the safety profile, the better it is for physicians to make decisions.”

Under the new FDA policy, drug companies will have to test drugs on greater numbers of high-risk patients, such as the elderly, those with relatively advanced diabetes and those with kidney problems.

Drug companies will also have to set up independent committees to monitor the rates of heart attacks, strokes and heart related deaths and hospitalisations linked to drugs in development.

Copyright Press Association 2008

FDA



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