The United States Food and Drug Administration (FDA) is warning consumers not to buy or use Slimming Capsules and Celerite Slimming Tea, two popular weight-loss products, because they contain a controlled substance that can increase blood pressure and pulse rate in those who take it.
Slimming Capsules and Celerite Slimming Tea, sold on various websites as a dietary supplements to lose weight makes false claims of being a “safe” and an “all-natural herbal weight loss remedy,” the FDA said in two advisories published early in 2011.
FDA laboratory analysis confirmed that Slimming Capsules and Celerite Slimming Tea both contain sibutramine, a controlled substance withdrawn from the U.S. market in October 2010 for safety reasons.
The maker, Shaping Beauty, Inc., has since voluntarily withdrawn both product, and as of March 2011, there have been no reports of illnesses or injuries caused by using any of the two products.
Saying it “sincerely sincerely regrets any inconvenience to customers,” the company worked with the FDA in the recall process.
The capsules and the tea pose a threat to consumers because sibutramine can substantially increase blood pressure and/or pulse rate in some patients.
Either product may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias and stroke.
“Consumers should stop using this product immediately and throw it away,” the FDA said. “Consumers who have experienced any negative side effects should consult a health care professional as soon as possible,” the agency said of the Celerite Slimming Capsules. It was less harsh in its advisory on the tea, recommending only that consumers return unfinished tea products to the manufacturer.
Celerite Slimming Capsules and Celerite Slimming Tea may also interact in life threatening ways with other medications a consumer may be taking, the FDA said in an advisory on May 10, 2011.
The FDA also warned that many products promoted for weight loss, sexual enhancement and bodybuilding—often represented as “all natural” dietary supplements—have hidden drugs and chemicals.
Consumers should exercise caution before buying products like these, since the FDA is unable to identify and test all products marketed as dietary supplements that have potentially harmful hidden ingredients, the agency said.
Until it was declared a controlled substance in the United States in 2010, sibutramine was routinely prescribed to people who wanted to lose weight, in combination with a reduced diet and an exercise regime.
Serious side effects of the drug include fast or pounding heartbeat, chest pain, shortness of breath, nausea, stomach pain, vomiting, extreme excitement, restlessness, anxiety, depression, dizziness, lightheadedness, fainting, confusion, uncoordinated or abnormal movement, muscle stiffness, shaking hands that you cannot control, seizures, shivering, excessive sweating, fever, sore throat, dilated pupils, change in vision, eye pain, hives, skin rash, itching, difficulty speaking, breathing, or swallowing, hoarseness, swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs and unusual bleeding or bruising.
Sibutramine is also contraindicated in patients with:
• Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or preexisting mania
• Patients with a history of or a predisposition to drug or alcohol abuse
• Hypersensitivity to the drug or any of the inactive ingredients
• Patients below 18 and above 65 years of age
• Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particularly other anoretics
• History of peripheral arterial disease
• Hypertension that is not sufficiently controlled (e.g., > 145/90 mmHg), caution in controlled hypertension
• Existing pulmonary hypertension
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
• A history of coronary artery disease (angina, myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack)
• Stroke or transient ischemic attack (TIA)
• Hyperthyroidism (overactive thyroid gland)
• Closed angle glaucoma
• Seizure disorders
• Enlargement of the prostate gland with urinary retention (relative C.I.)
• Pregnant and lactating women (relative C.I.)
Slimming Capsules and Celerite Slimming Tea were sold nationwide on the Internet and both products still has a fairly wide Internet presence. A google search for the tea produces almost 70,000 results, while a search for the capsules produces 17,000 results.
Consumers are advised to return the product to:
Shaping Beauty, Inc.
P.O. Box 1032
United States 18966
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at 1-800-332-1088 or complete and submit the report online at www.fda.gov/MedWatch/report.htm