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Sibutramine Suspended in Europe



Yesterday, the European Medicines Agency recommended the suspension of marketing authorisation for sibutramine across the European Union. Sibutramine is marketed as Reductil, Reduxade, Zelium and other tradenames in the European Union.

This recommendation comes after completion of a safety review of the Agency’s Committee for Medicinal Products for Human Use (CHMP). The review was prompted by data from the 10,000-patient Sibutramine Cardiovascular Outcome (SCOUT) trial , which showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, with sibutramine compared with placebo.

While the CHMP noted that the use of sibutramine was not in accordance with the prescribing information for most of the patients enrolled in the SCOUT study, as sibutramine is contra-indicated in patients with known cardiovascular disease and the treatment duration in the study was longer than recommended, the Committee was of the opinion that the data from SCOUT are relevant for the use of the medicine in clinical practice.

The EMA’s recommendation remains to be ratified by the European Commission

Yesterday, the US Food and Drug Administration (FDA) also released a statement that it has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia.

The release notes that while the sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease, based on the serious nature of the review findings, the FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.

The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:

– History of coronary artery disease (e.g., heart attack, angina)
– History of stroke or transient ischemic attack (TIA)
– History of heart arrhythmias
– History of congestive heart failure
– History of peripheral arterial disease
– Uncontrolled hypertension (e.g., > 145/90 mmHg)

The FDA release further states that patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.

The final results of the SCOUT study have yet to be published in a peer reviewed journal.

AMS
Edmonton, Alberta

Disclaimer: I have received speaking, consulting and research support from Abbott, the maker of sibutramine and am on the Executive Steering Committee of the SCOUT study.

3 Comments

  1. Dr Sharma

    I was wondering if you have any rough idea when further results will be published in a peer-review journal from the SCOUT? Am I correct in thinking that primary data analysis is set to complete in March (that’s what the clinical trials listing suggesting on CT.gov)?

    The preliminary safety findings that have been realised by the DSMB do seem to indicate that the cardiovascualar effects, which were analysed as being pretty minor in the preliminary analyses from the lead-in period that have been published, do have a clinically significant negative effect in the long term.

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  2. This SCOUT result is not unexpected .This is despite of two third of patients of SCOUT being on beta blaockers which had baised the trial to an favorable ratio.So with the current result it clearly means that sibutramine is a cardiotxic compund and apart from adverse CV outcome this medication has serious neuropsychiatric side effects.It only survived as it had US Abbott Pharma msucle power and Obese people have been dumped on with a toxic compound.Its high time to dump this medication rather than fallig prey to greedy commercial pharma gaint like Aboott whose is still arrongant to continue the drug outside EU.Shame on them

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  3. To Rafi: As described in the EMEA press releases, the main negative impact was on non-fatal events. There was no increase in fatal events, however as the primary endpoint was a combination of fatal and non-fatal events, the overall results are negative. As also pointed out in the press release, SCOUT was conducted in a high-risk population (off-label) so the data cannot be easily extrapolated to individuals with lower CV risk. We hope the paper will be accepted and out in the next couple of months.

    To Shashank: I agree that SCOUT shows that this is clearly not a drug for high-risk patients. It also shows the value of companies like Abbott investing heavily in studies such as SCOUT to fully understand the benefits (or limitations) of their compounds. I agree that as physicians we must all look at the data and make our own judgements on what is best for our patients.

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