Slimming tablets and a tape measure

Fda category

FDA Investigates Reductil Concerns

Posted: Monday, 23 November, 2009 | Categories: Reductil, FDA

The Federal Food and Drug Administration has flagged up a report warning that the slimming pill Reductil could increase the risk of someone experiencing a heart attach or stroke.

The preliminary data from the SCOUT study indicated that when two control groups were compared, those taking the pills rather than the placebo were at a higher risk of experiencing an adverse event related to the heart. The study was designed to investigate the long-term effects of the drug on people with high cardiovascular risk.

Reductil already is not recommended for patients with a history of cardiovascular disease. 90% of patients who took part in the SCOUT study were not eligible to be prescribed the medication and though Abbott Laboratories are reviewing the data they do not believe they is any need to change the safety profile of the drug. They emphasised that they already highlighted that the medication was not suitable for patients with a history of heart disease, congestive heart failure and stroke and made this information clear on the packaging.

The FDA insisted that at the moment they have drawn no conclusions about the safety of the drug. The European Medicines Agency has also instructed their Committe for Medicinal Products for Humans to conduct a safety review into sibutramine, the medical name for Reductil.