Sibutramine Suspended in EuropeFriday, January 22, 2010
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.
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.