Reminder on the Use of Dexamethasone

June 19, 2020

FDA ADVISORY NO. 1131-20

 

The Food and Drug Administration (FDA) strongly reminds the public that Dexamethasone is a prescription drug and should strictly be used under the supervision of a licensed physician. There are Dexamethasone products that are currently registered with the FDA. The drug should be only dispensed by licensed establishments to patients with valid prescription. The sale of unregistered Dexamethasone or sale of the drug without valid prescription or through online platforms is strictly prohibited.

Dexamethasone is a steroid drug and is prescribed by a licensed physician based on the patient's medical condition. Misuse or unsupervised chronic use of this drug may lead to serious adverse reactions such as:

• Immunosuppression or impairment of the body's ability to fight infections

• Gastrointestinal bleeding and ulcers

• Electrolyte imbalance

• Osteoporosis

• Muscle weakness

• Poor wound healing

• Prolonged use of the drug may cause suppression of growth among infants and children

• Obesity

If stopped abruptly, it may cause withdrawal symptoms such as hypotension, shock, and coma. 1

All are enjoined to report the dispense and/or use of the drug without a valid prescription to FDA Center for Drug Regulation and Research at [email protected]. For any observed adverse reactions with the use of the drug, seek medical attention immediately and report to the FDA at https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields. All violators shall be dealt with legal actions.

For your guidance. CAIHTE

(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General

 

Footnotes

1. https://products.mhra.gov.uk/search/?search=dexamethasone&page=1&doc=Pil.