Cardiac fears over obesity drug December 7, 2009Posted by Dreamhealer in Big Pharma.
Drug regulators have warned GPs about a potential safety risk with the obesity treatment sibutramine after a study that found an excess of serious cardiovascular events in high-risk patients on the treatment.
Both the European Medicines Agency and the US Food and Drug Administration have announced reviews into sibutramine, a centrally acting serotonin and noradrenaline reuptake inhibitor that suppresses appetite.
The UK drugs regulator, the Medicines and Healthcare products Regulatory Agency, said: ‘Patients with existing cardiovascular diseases should not be prescribed sibutramine and blood pressure and heart rate should be carefully monitored during treatment.’
The MHRA called on GPs to ensure they followed safety advice in the drug’s prescribing information.
Preliminary results from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes (SCOUT) study given to the FDA showed that 11.4% of patients taking sibutramine had a heart attack, stroke, resuscitated cardiac arrest or death compared with 10% of those taking placebo. Read More…