December 23, 2010
FDA warns of undeclared ingredient in Fruta PlantaThe FDA has notified consumers and healthcare professionals that Fruta Planta, a product marketed as a dietary supplement for weight loss, should not be purchased or used because it contains undeclared sibutramine, a product that was withdrawn from the market in October 2010 due to safety reason. Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may be a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Patients who have these products in their possession should stop using them immediately and contact their healthcare provider if they experience any adverse effects related to the use of these products.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238052.htm.