The Food and Drug Administration (FDA) is advising consumers not to purchase or use Japan Hokkaido Slimming Weight Loss Pills, a product promoted and sold for weight loss on various websites and in some retail stores.
FDA laboratory analysis confirmed that Japan Hokkaido Slimming Weight Loss Pills contain sibutramine, benzocaine, phenolphthalein and diclofenac.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.
Benzocaine is a local anesthetic. It is the active ingredient in many over-the-counter (OTC) products used to relieve pain in the mouth and gums from a variety of conditions. Benzocaine use may cause methemoglobinemia, a rare, but serious and possibly fatal condition where the amount of oxygen that can be carried through the blood stream is greatly reduced.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
Diclofenac is a non-steroidal anti-inflammatory (NSAID) drug that can cause increased risk of cardiovascular events, such as heart attack and stroke. Diclofenac, like other NSAID drugs, can also lead to serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online: MedWatch Online Voluntary Reporting Form
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
Please refer to the links below for more information: