Irish diabetes sufferers urged not to panic over drug scare
Consultant endocrinologist Dr Graham Roberts said doctors had been aware for some considerable time that there might be question-marks over the use of the drugs to treat patients suffering from, or at risk of heart failure. And, he said, doctors were aware that the risks should be considered when prescribing the drugs.
New research published in Diabetes Care suggests that fluid retention caused by the two drugs — rosiglitazone and pioglitazone — used to treat type-2 diabetes may be to blame for increasing the heart failure risk.
Both drugs have been available in the State for a number of years.
British and American researchers, who used data from 78,000 patients, found that one in 50 patients taking the drugs over a 26-month period would suffer heart failure and need admission to hospital.
More than 200,000 people in Ireland have diabetes and the number of type-2 diabetes, the most common kind, is increasing rapidly.
Another study published in The New England Journal of Medicine in May linked rosiglitazone, which is more widely used in Ireland than pioglitazone, to a 43% increased risk of heart attacks.
It is understood that since the study was published doctors treating diabetics have been reluctant to start prescribing the drug for new patients until the United States’ Food and Drug Administration (FDA) issues a statement on Monday.
The FDA, which has been examining the earlier study on rosiglitazone, will decide whether the data merits adding so-called “black box” warnings to the drug.
A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is so named for the black border that usually surrounds the text of the warning.
Dr Roberts said the FDA was the appropriate body to rule on the safety issues in the US where the drug was more widely used.
He said the FDA would consider the relative benefits of rosiglitazone, compared to the known risks. “It should be left to the FDA to consider the issue fairly for the US rather than have a trial by media,” he stressed.



