[5-4-2015] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Saurean Fong Sep Lin, a product promoted for backache. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Saurean Fong Sep Lin contains dexamethasone, a corticosteroid, and cyproheptadine.
Consumers taking Saurean Fong Sep Lin are urged to immediately consult with their health care provider to safely discontinue use of this product. The risks 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. To date, FDA is not aware of any reports of adverse events related to this product.
- Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. 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.
- Cyproheptadine is a prescription antihistamine used for seasonal allergy treatment. Antihistamines may cause drowsiness and affect mental alertness.
In addition, these undeclared ingredients in Saurean Fong Sep Lin may cause serious side effects when combined with other medications.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
- Download and complete the form, then submit it via fax at 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.
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