Cyproheptadine FDA Alerts
The FDA Alerts below may be specifically about cyproheptadine or relate to a group or class of drugs which include cyproheptadine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for cyproheptadine
Mayhem: Public Notification - Undeclared Drug Ingredients
ISSUE: FDA is advising consumers not to purchase or use Mayhem, a product labeled as a dietary supplement that is promoted to increase appetite and muscle growth, because it contains an undeclared corticosteroid and antihistamine. FDA laboratory analysis found that Mayhem contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.
Consumers are advised that 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 Mayhem may cause serious side effects when combined with other medications.
BACKGROUND: Mayhem is manufactured by Chaotic-Labz and is sold in some retail stores and on various websites, including www.chaoticlabz.com
RECOMMENDATION: Consumers taking Mayhem are urged to immediately consult with their health care provider to safely discontinue use of this product. This 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.
Healthcare 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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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