IS IT SAFE?:Serious concerns about new diabetes drug

Muraglitazar has been given the green light by America’s drugs regulator, the Food and Drug Administration (FDA). Its special advisory committee looked at the safety record, together with data from trials, and recommended its approval, which was duly given last October.

However, when a research team from Cleveland Clinic Foundation analysed the exact same data reviewed by the FDA advisory committee, they concluded that the drug is highly dangerous. Of the 2374 patients who were involved in testing the drug, 35 either died, or suffered a heart attack or stroke, and another 50 experienced either a TIA (transient ischaemic attack, a form of stroke), or chronic heart failure.

On that basis, the drug should never have been approved, the research team concluded. So how did it happen? One difference was that the pharmaceutical company that makes the drug made the presentation to the safety committee, whereas the Cleveland research team just looked at the raw data. The drug company also included a large group of people, taking minimal doses of the drug, who did not suffer any adverse reactions. Inclusion of these subjects diluted the figures, making a seemingly large problem appear almost insignificant.

In addition to the life-threatening reactions, the drug also caused major weight gain, and increased the risk of oedema (swelling due to water retention) by 10 per cent.

The drug’s manufacturer has agreed to undertake a five-year safety trial involving 15,000 patients but, in the meantime, the drug will continue to be freely available on prescription (JAMA, 2005; 294: 2581-6, 2633-5).

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Written by What Doctors Don't Tell You

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