The U.S. Food & Drug Administration reviewed several incidents of serious adverse events associated with the use of Apetamin, which is being marketed illegally for weight gain & figure augmentation.
Apetamin is not an FDA-approved product. It is manufactured overseas & illegally imported into the U.S. Although the FDA restricted importation of Apetamin, the product continues to find its way into the U.S. market, often via online marketing & in some retail stores. Apetamin is heavily promoted & sold through social media, targeting people seeking to gain weight & achieve a certain physique.
Apetamin contains cyproheptadine, a potent antihistamine that requires a physician’s prescription in the U.S.
Dangerous Adverse Effects
Consumers may not be aware of the serious adverse effects associated with cyproheptadine or the amount that is contained in Apetamin. Because cyproheptadine is a strong antihistamine, which is often used to treat symptoms of allergies, it can cause sedation, cognitive impairment, dizziness, & low blood pressure. Antihistamine overdose is very dangerous, & within six hours may result in severe adverse effects such as:
- Disorientation & confusion
- Decreased breath & heart rates
Apetamin use may also decrease mental alertness & consumers should be warned about engaging in activities requiring mental alertness & motor coordination, such as driving a car or operating machinery. Strong antihistamines, like cyproheptadine found in Apetamin, may have additive effects when used with alcohol & other central nervous system depressants, (e.g., hypnotics, sedatives, tranquilizers, & antianxiety agents).
The agency reviewed several recent adverse event reports from the FDA Adverse Event Reporting System (FAERS) & the published literature involving young adults taking Apetamin & experiencing nervous system disorders (e.g., dizziness, sleepiness, & tremor), cardiac disorders (e.g., irregular heartbeat), & liver injury. In addition to the reported events, the FDA is concerned the real number of consumers experiencing adverse events is higher due to underreporting.
One published report describes a person who developed autoimmune hepatitis after six weeks of daily Apetamin use. This type of hepatitis is a chronic disease & could develop into a lifelong disease. It is treated with corticosteroids & immune system suppressors, & if left untreated, can cause liver failure.
Don’t Risk Your Health – Seek Professional Advice
Consumers, caregivers, & parents should seek medical advice from a health care professional for safe weight gain treatment options.
The FDA encourages anyone who suspects they have experienced an adverse medical event related to Apetamin, or other similar products, to report this using FDA’s MedWatch Adverse Event Reporting program, using the Center for Food Safety & Applied Nutrition Adverse Event Reporting System, or by calling 1-888-SAFEFOOD (1-888-723-3366).
Additionally, you can reach out to your local consumer complaint coordinator: Consumer Complaint Coordinators.
Source: FDA Consumer Updates