ISSUE: FDA notified consumers not to purchase or use “Ginseng Kianpi Pil,” a product promoted to stimulate appetite, promote weight gain and relieve fatigue, because it contains an undeclared corticosteroid and an antihistamine. FDA laboratory analysis found that Ginseng Kianpi Pil contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.
Corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in “Ginseng Kianpi Pil” may cause serious side effects when combined with other medications.
BACKGROUND: Ginseng Kianpi Pil is manufactured by Kweilin Drug Manufactory, and sold in retail stores and on various websites.
RECOMMENDATION: Consumers taking “Ginseng Kianpi Pil” are urged to immediately consult with their health care professional to safely discontinue use of this product. The risk of withdrawal from corticosteroids should be assessed by a health care professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression.
FDA encourages health care professionals and consumers to report any adverse events or side effects associated with the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- 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
[10/30/2014 - Public Notification - FDA]