Cardiovascular Risk with Sibutramine [Meridia] in Patients with a History of Cardiovascular Disease

Last Updated on

April 11, 2010 – FDA is alerting healthcare professionals that Sibutramine [Meridia] is contraindicated in patients with a history of cardiovascular disease because the drug increases their risk of heart attack and stroke. Sibutramine [Meridia] is used to manage obesity.

In November 2009, an early communication from FDA reported preliminary study results suggesting that patients on Sibutramine [Meridia] had a greater frequency of cardiovascular events than those not taking the drug. Additional data from the study has shown that the excess risk occurred in patients with a history of cardiovascular disease.

Based on this information, Sibutramine [Meridia] is now contraindicated in patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), cardiac arrhythmias, congestive heart failure, peripheral arterial disease, or uncontrolled hypertension. Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using Sibutramine [Meridia] and discontinue the drug if there are sustained increases in these measurements.

They should also discontinue Sibutramine [Meridia] in patients who do not lose at least 5 percent of their baseline body weight within the first three to six months of treatment, because further treatment is not likely to be effective and exposes the patient to unnecessary risk. Patients using Sibutramine [Meridia] should talk with their healthcare professional about whether to continue using the drug.

It is noteworthy that the European Agency for Medicinal Products (EMEA) earlier this year already concluded that the risks of Sibutramine containing medicines, previously on the market in Europe as Reductil, Reduxade, and Zelium, are greater than their benefits and recommended the suspension of marketing authorisations for these medicines across the European Union.   The Agency said that doctors should no longer prescribe, and pharmacists should no longer dispense the medicine.

This action in the European Union was taken based on the data from the Sibutramine Cardiovascular Outcome Trial (SCOUT) showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, with sibutramine compared with placebo. The SCOUT trial, in which nearly 10,000 patients were enrolled for up to six years, was designed to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese subjects with known or high risk for cardiovascular disease.

The American Food and Drug Agency (FDA), on the other hand, notified health care professionals that its review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. The decision come after the agency’s November 2009 Early Communication about an ongoing safety review of sibutramine, marketed as Meridia by Abbott, which has agreed to add the stronger warnings. Based on the serious nature of the review findings, the agency requested and the manufacturer – Abbott – agreed to add a new contraindication to the drug’s label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including a history of: coronary artery disease (eg, heart attack, angina), stroke or transient ischemic attack (TIA) heart arrhythmias, congestive heart failure, peripheral arterial disease; and uncontrolled hypertension.

View Original Article

Blogged with the Flock Browser

Tags: , ,
About the Author
thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Leave a Reply

Optional: Social Subscribe/Login




avatar
  Subscribe  
Notify of

thasso: conditions

thasso: tweets

thasso post: magazine

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Genes, the social environment, and adolescent smoking September 17, 2019
    Adolescence is a time of dramatic change. It marks a period of significant physical transformation—such as the drive toward sexual maturity. But it can also be a time of considerable psychological change and social experimentation.
  • Cause of rare, fatal disorder in young children pinpointed September 17, 2019
    Scientists at Washington University School of Medicine in St. Louis appear to have solved a decades-long mystery regarding the precise biochemical pathway leading to a fatal genetic disorder in children that results in seizures, developmental regression and death, usually around age 3. Studying a mouse model with the same human illness—called Krabbe disease—the researchers also […]
  • Gene-targeted cancer drugs, slow release overcome resistance September 16, 2019
    Biomedical engineers at Duke University have developed a method to address failures in a promising anti-cancer drug, bringing together tools from genome engineering, protein engineering and biomaterials science to improve the efficacy, accuracy and longevity of certain cancer therapies.
  • Genetic mutation appears to protect some people from deadly MRSA September 16, 2019
    An inherited genetic tendency appears to increase the likelihood that a person can successfully fight off antibiotic-resistant staph infections, according to a study led by Duke Health researchers.
  • Renegade genes caught red handed September 16, 2019
    The guardians of the human genome that work to prevent potentially disease-causing gene expression might not be as effective at their jobs as previously thought, according to new University of Arizona research.
Top