FDA alerts consumers of undeclared drug ingredients in over-the-counter diabetes product
[7-23-2013] The U.S. Food and Drug Administration is advising consumers not to purchase or use “Jiang Tang Yi Huo Su Jiao Nang,” a drug product promoted and sold as a diabetes treatment. The product contains three active pharmaceutical ingredients, including one that was removed from the U.S. market because of the risk of serious side effects.
FDA laboratory analysis found that “Jiang Tang Yi Huo Su Jiao Nang” contains the following undeclared active ingredients:
- Glyburide – An active ingredient found in several FDA-approved prescription drugs used to treat type 2 diabetes. Glyburide is capable of causing significant low blood sugar or hypoglycemia. Signs and symptoms of hypoglycemia include, sweating, shakiness, confusion, anxiety, hunger, and heart palpitations.
- Metformin – An active ingredient found in several FDA-approved prescription drugs used to treat type 2 diabetes. Although rare, in certain conditions metformin can accumulate in the body and cause a serious metabolic complication known as lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. Signs of lactic acidosis can be non-specific, such as weakness, tiredness, unusual muscle pain, trouble breathing, unusual stomach discomfort, feeling cold, dizziness or lightheadedness, and sudden slow or irregular heartbeat.
- Phenformin – An active ingredient that was removed from the U.S. market in November 1978 because of the occurrence of lactic acidosis in patients with diabetes using phenformin.
FDA-approved drugs containing the active ingredients glyburide and/or metformin are safe when prescribed under the supervision of a licensed health care professional. Also, drugs approved by FDA have undergone a rigorous drug approval process ensuring safety and efficacy for their intended purposes. Products, such as, “Jiang Tang Yi Huo Su Jiao Nang,” that have not been approved by FDA, carry potentially dangerous risks. There is a risk these types of products may contain hidden active ingredients, may contain unknown harmful ingredients, may be contaminated, or may be of poor quality.
“Jiang Tang Yi Huo Su Jiao Nang” or “降糖胰活素胶囊” (translates – anti-diabetic pancreatic capsule) is sold on various websites, including www.ecrater.com, and may be sold in some retail stores.
The drug ingredients in “Jiang Tang Yi Huo Su Jiao Nang” may interact with other medications and can cause serious adverse events. Consumers should stop using this product and notify their health care professional immediately. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. To date, FDA is not aware of any reports of adverse events related to this product.
“Jiang Tang Yi Huo Su Jiao Nang” is labeled in Chinese and mainly found on websites in Chinese. However, this product may be distributed on websites in English. “Jiang Tang Yi Huo Su Jiao Nang” is manufactured and/or distributed by 郑州千济生物科技有限公司监制 (translated: Zhengzhou Thousand Economies Science and Technology Co., Ltd.) under the brand, 千济 (translated: Thousand Economies).
Health care professionals and consumers are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/MedWatch/report.htm
- Download and complete the form, then submit by fax to 1-800-FDA-0178