MANILA, Philippines - The Food and Drugs Administration (FDA) warned yesterday that the use of injectable glutathione, a substance popularly used as a skin whitener, is not approved by the agency due to its potentially fatal consequences.
In an advisory, FDA director Dr. Suzette Lazo said injectable glutathione is “unsafe and may result in serious consequences to the health of users” if administered “at a very high dose.”
“The public is strongly warned to refrain from using glutathione for this purpose in light of potential harm associated with such use,” said Lazo, who claimed there has been an “alarming increase in the unapproved use” of the product.
The FDA has received reports of “adverse drug reactions” ranging from “skin rashes to the serious and potentially fatal Stevens-Johnson syndrome and toxic epidermal necrolysis,” in which cells that form the outer layer of the skin die, exposing the layer beneath.
Lazo added that the use of injectable glutathione can also lead to derangement in thyroid function; kidney failure and severe abdominal pain in a patient “receiving twice-weekly glutathione administered intravenously.”
She said the incorrect administration of injectable glutathione by untrained personnel can cause sepsis, air embolisms, and the transmission of blood-borne diseases if they use unsafe needles.
The advisory describes glutathione as a compound naturally found in the body, generated by the liver and acts as an antioxidant. It is composed of the amino acids glutamine, glycine and cysteine and is “not normally required because it is abundant in foods such as fresh fruits and vegetables.”
“It may have the effect, although disputed by many, of skin whitening by inactivating the enzyme tyrosinase, which is necessary in melanin production and converts this pigments to the lighter phaecomelanin,” the advisory stated.