The European Medicines Agency (EMA) has raised concerns that a ‘fat-busting’ pill might be linked to an increased risk of heart attack and stroke.

The Daily Mail reports that the prescription-only drug Reductil – which works by ‘tricking’ the stomach into thinking it is full – has been linked to 17 fatalities among patients taking the medication to lose weight.

The risks of Reductil were examined in a trial that recruited 10,000 patients internationally and followed them for six years. Researchers found that the drug’s active ingredient Sibutramine might increase the risk of patients developing heart conditions. Around 330,000 prescriptions for the drug were issued in 2008 alone.

The trial mostly recruited patients who were obese or overweight, with some already suffering from cardiovascular conditions. Patients suffering from heart problems would normally not be prescribed Reductil as it can increase blood pressure slightly.

Following the findings of the Sibutramine Cardiovascular Outcome Trial (SCOUT), EMA is advising doctors to issue prescriptions ‘with caution’ until it publishes its response to the study – and the implications of the trial’s findings for all patients – later in January.

Makers of Reductil – Abbott Laboratories – said that despite the findings, Sibutramine was ‘an important’ treatment for patients suffering from obesity.

‘Our ongoing evaluation of the SCOUT study data does not change our medical assessment of Sibutramine’s risk/benefit profile, when used appropriately in the approved patient population,’ said a spokesman.

The UK’s drugs watchdog The Medicines and Healthcare products Regulatory Agency said it was also reviewing data from the trial. To date, there have been 2,094 suspected adverse reactions to Reductil recorded since it was introduced in 2001. Out of the 17 patients who died, six fatalities were caused by heart problems and strokes.

The effect of Sibutramine is to block nerve cells that control the hormone serotonin, which affects moods and appetite. By allowing levels of serotonin in the brain to rise, patients maintain a feeling of fullness and so eat less and lose weight.

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