Injectable gluta for whitening not supported by DOH

The FDA said injectable glutathione is sometimes even paired with intravenous Vitamin C, which puts a person at risk of getting kidney stones if his/her urine is acidic. (Pexels Photo)

MANILA – The Department of Health (DOH) on Saturday said it does not support the use of injectable glutathione for skin whitening.

“Injectable glutathione is approved by FDA (Food and Drug Administration) Philippines as an adjunct treatment in cisplatin chemotherapy.

The FDA has not approved any injectable products for skin lightening,” it said.

Cisplatin is an antineoplastic agent to treat advanced cancer of the bladder, ovaries or testicles.

In a statement, the agency reiterated FDA Circular No. 2019-182, where it categorically stated that there are no published clinical trials that evaluated the use of injectable glutathione for skin lightening.

On top of this, the DOH said there are no published guidelines for appropriate dosing regimens and duration of treatment.

The DOH reminded the public that once the FDA has approved a prescription drug for entry into the Philippine market, neither the DOH itself nor the FDA can regulate the practice of doctors who will be prescribing those drugs for their patients.

It said physicians are authorized by their license to practice medicine granted by the Professional Regulation Commission.

The FDA said injectable glutathione is sometimes even paired with intravenous Vitamin C, which puts a person at risk of getting kidney stones if his/her urine is acidic.

According to the FDA, the side effects of the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys and nervous system.

Also of concern is the possibility of Stevens Johnson Syndrome, a rare and serious disorder of the skin and mucous membranes that manifests in rashes, discolorations and blisters.

“Given that glutathione affects the production melanin (the pigment that gives the human skin, hair and eyes their color), there are theoretical concerns about the long term skin cancer risk,” it said.

“Other potential risks include transmission of infectious agents, such as HIV (human immunodeficiency virus), hepatitis C and B. This is of particular concern when non-medical practitioner administers this treatment or done in a non-sterile facility,” it added.

Should a person think that injectable glutathione was wrongly prescribed by a physician, the DOH said the patients can consults a practicing lawyer or the Public Attorney’s Office for legal advice on matters such as medical negligence.

In cases of side effects due to the use of any drug, including injectable glutathione, the user is advised to seek medical attention immediately and report it to FDA at pharmacovigilance@fda.gov.ph or call the Center for Drug Regulation and Research at (02) 8809-5596.