There appears to be serious consternation in the medical community surrounding the suspension of the marketing authorisation for Sibutramine across the EU. Sibutramine is marketed as Reductil in the UK and as Meridia in the US. As we have reported in an earlier article, Sibutramine was withdrawn following reports from an ongoing study into the effects of Sibutramine on patients with known cardiovascular problems. As Reductil (sibutramine) should not be prescribed to this group of overweight patients, there is a strong argument that the case for the suspension of Sibutramine’s marketing authorisation was not wholly supported by clinical evidence but based on conjecture as to how the medicine might affect someone who had no previously diagnosed cardiovascular problems.
Reductil was administered to patients for 6 years to monitor its effect on cardiovascular risk in this group of patients. During the trial, the patients being treated with Reductil had a statistically significant higher occurrence of non fatal heart attacks and strokes. Reductil is normally only prescribed for one year although some doctors will prescribe it for up to 2 years and this timescale accords with the drug’s license in the US. Treating patients who are contraindicated for the medication in the first place for a period of time three times the normal maximum prescribing time must make the incidence of adverse events much more likely surely?
So how have other licensing authorities responded to this clinical trial report? The FDA in the US has not withdrawn Sibutramine but merely enhanced the warning label. The same action has also been taken by the licensing authority for Australia and New Zealand. It is our view that the decision to suspend Reductil will be overturned at a later date.