Early Communication about an Ongoing Safety Review of Reductil (sibutramine hydrochloride)


The Saudi Food and Drug Authority (SFDA), resembled by the National Pharmacovigilance Centre (NPC), is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Reductil, a prescription drug, in Saudi Arabia.

Reductil (sibutramine 5mg, 10mg, 15mg) was approved in Saudi Arabia in 2003 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Reductil is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).

The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) began in 2002. The study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care.

Patients included in the study were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. Approximately 10,000 patients enrolled in the study.

The preliminary analysis of the primary endpoint suggests that patients using sibutramine experienced a higher number of cardiovascular events compared to those using a placebo. The preliminary data shows that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected, suggesting that sibutramine is associated with an increased cardiovascular risk in the study population.

This early communication is in keeping with NPC’s commitment to inform the public about its ongoing safety reviews of drugs. SFDA understands the serious nature of the preliminary data and is conducting an expedited safety review. SFDA will communicate its findings to the public as soon as this review is complete.

Considerations for consumers and healthcare Professionals:

The preliminary study findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling. Additionally, healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories. Consumers should discuss with their healthcare professional about whether sibutramine is appropriate for them.

Report Adverse Drug Reactions to the Saudi FDA

The SFDA urges both healthcare professionals and patients to report side effects from the use of botulinum toxin products to the SFDA either online, by regular mail or by fax, using the following contact information :

National Pharmacovigilance Center (NPC)

Saudi Food and Drug Authority-Drug sector

3292 Northern Ring Road

Al Nafal District

Riyadh 13312 – 6288

Kingdom of Saudi Arabia

Email : NPC.Drug@sfda.gov.sa

Website: www.sfda.gov.sa/NPC-E