DOH: No FDA approval on injectable glutathione for skin lightening

MANILA, Philippines — The Department of Health (DOH) said on Saturday that the Food and Drug Administration (FDA) has not approved any injectable products, including glutathione, for skin lightening.

According to its statement, while injectable glutathione is used in cisplatin chemotherapy, there have been no clinical trials yet on its use for skin lightening.

READ: DOH warns against use of intravenous glutathione for skin whitening

“DOH categorically states that there are no published clinical trials that have evaluated the use of injectable glutathione for skin lightening. There are also no published guidelines for appropriate dosing regimens and duration of treatment,” the statement said.

“Injectable glutathione is approved by FDA Philippines as an adjunct treatment in cisplatin chemotherapy. The FDA has not approved any injectable products for skin lightening,” it added.

In January, Health Secretary Teodoro “Ted” Herbosa made the same statement that the FDA has not yet approved any use of the clinical product for cosmetic purposes.

“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. Physicians are authorized by their license to practice medicine granted by the Professional Regulation Commission (PRC),” the DOH continued.

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The DOH also advised those who use injectable glutathione and have experienced side effects to seek medical attention immediately and to contact the FDA.

“If you experience any side effects due to the use of any drug, including injectable glutathione, seek medical attention immediately and report it to FDA at pharmacovigilance@fda.gov.ph or via online reporting through our website: www.fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596,” it said.

Meanwhile, it also encouraged people who may have been wrongly prescribed injectable glutathione to consult a lawyer for advice.

“For the next steps to take should you think that injectable glutathione was wrongly prescribed for you by a physician, please consult a practicing lawyer or the Public Attorney’s Office for legal advice on matters such as medical negligence and what may be done in the interest of justice,” the statement concluded.

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