SmartLipo365 is recalling all lots of Smart Lipo diet pills after federal agents discovered the diet pills contain undeclared and/or unapproved drugs that could cause life-threatening events in those who take them.
A Food and Drug Administration (FDA) analysis found that Smart Lipo capsules contain sibutramine, desmethylsibutramine and phenolphthalein.
Sibutramine, which was the drug ingredient in the prescription weight loss drug Meridia, is an appetite suppressant that was removed from the U.S. market in 2010 after it was found to increase blood pressure and/or pulse rate in some people. This could be deadly for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stoke.
Phenolphthalein is an ingredient that was once used in over-the-counter laxatives but was discontinued under suspicions that it could be carcinogenic. Health risks associated with phenolphthalein include gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules in 800mg, 900mg and 950mg per capsule. The diet pills were sold in retail stores and distributed nationwide through the internet through SmartLipo365.com.
Earlier this month, the FDA issued warnings regarding undeclared drug ingredients in in two other diet pills marketed as dietary supplements – Pink Bikini and Lipo Escultra.
Consumers who have taken these pills should contact their doctors with any health concerns. Any side effects should also be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.