IS IT SAFE? Serious concerns about new diabetes drug
There’s a new drug group on the block thats supposed to be the great hope for treating type 2 diabetes. The group is known as peroxisome proliferator-activated receptors, and its first representative is a drug with the unpromising generic name of muraglitazar, although the marketing boys will doubtlessly come up with something like Diabeto. Muraglitazar has been given the green light by America drug 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. From that day on, the manufacturer’s sales team would have gone into frenetic overdrive, and doubtlessly there are people who are already taking the drug. 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 2,374 patients who tested the drug, 35 either died, suffered a heart attack or stroke, and another 50 on the drug suffered 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 drug manufacturer 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 who were taking minimal doses of the drug, and who didn’t’ suffer any adverse reaction. This inclusion diluted the figures, so making a seemingly large problem something almost insignificant. In addition to the life-threatening reactions, the drug also caused major weight gain and a 10 per cent risk of edema. So what happens now? The manufacturer has agreed to undertake a five-year safety trial involving 15,000 patients but, in the meantime, the drug will presumably continue to be freely available on prescription. Doctors, after all, believe the drug has been given a clean bill of health. Its down to the FDA to do the right thing. But will they? (Source: Journal of the American Medical Association, 2005; 294: 2581-6, and 2633-5).