Health Canada Provides 2007 Update On Reports Of Suspected Meridia Adverse Reactions
Meridia Can Increase Blood Pressure And Heart Rate Leading To Possible Serious Cardiovascular Problems
(Posted by Tom Lamb at DrugInjuryWatch.com)
The Canadian Adverse Reaction Newsletter (CARN) released in October 2007 (Volume 17, Issue 4) includes an article about the anti-obesity drug Meridia (sibutramine), "Contraindicated use of sibutramine and cardiovascular adverse reactions". This article updates us on the safety profile of Meridia, which is made for the Canadian market by Abbott Laboratories Ltd.
As background, in March 2002 Meridia was the subject of a Health Canada investigation which resulted in this February 2003 report on the safety of Meridia.
This October 2007 Canadian Adverse Reaction Newsletter article updates that Meridia safety profile report with this information:
Health Canada continues to receive reports of ARs in patients using sibutramine who have contraindications. From Jan. 1, 2001, to May 31, 2007, Health Canada received 65 reports of cardiovascular ARs suspected of being associated with sibutramine. Thirteen of these reports involved patients with at least 1 contraindicated condition....
Contraindications for sibutramine therapy include:
- History of coronary artery disease, congestive heart failure, arrhythmias or cerebrovascular disease (stroke or transient ischemic attack)
- Inadequately controlled (> 145/90 mm Hg) or unstable hypertension
- Psychiatric illness
- Concomitant use of centrally acting drugs (e.g., antidepressants and antipsychotics) or herbal remedies (e.g., St John's Wort) for the treatment of psychiatric disorders; monoamine oxidase inhibitors; or other centrally acting weight-reducing agents
- History of, or presence of, a major eating disorder such as anorexia nervosa or bulimia nervosa
- Hypersensitivity to sibutramine or to any ingredient in the formulation or component of the container
This Health Canada Meridia article goes on to provide a brief description of the 13 cardiovascular adverse reaction cases that involved one or more of these contradicted conditions.
Furthermore, in this article Health Canada advises doctors and patients, both, to check the Meridia package insert, or label, before starting Meridia so as to be aware of the contraindications and avoid a possible serious adverse reaction.
