Federal Drug Regulatory Authority of United States warns against use of intravenous glutathione for whitening or lightening treatments. Source: 

What is glutathione? Glutathione is a molecule composed of three amino acids (glutamine, cysteine, glycine). It is produced inside our cells (endogenous) and functions as an important antioxidant, for metabolism, and body regulation. Glutathione is naturally found in fresh food and can be man-made as glutathione-containing products (i.e. oral and injectable nutritional supplements, inhaled drug, skin products).1,2

What are the approved uses of glutathione products in the Pakistan? NONE OF THE SYSTEMIC GLUTATHIONE CONTAINING PRODUCTS AROUND THE WORLD HAVE BEEN APPROVED FOR SKIN WHITENING.3,4  The Drug regulatory Authority of Pakistan DRAP has approved oral glutathione products as nutritional supplements only.  Injectable (intravenous/ “drips”) glutathione has only been approved as a drug to protect cancer patients from nerve side-effects of platinum-based chemotherapy.5

Is glutathione a proven skin whitening agent? Not yet. Current scientific evidence is not strong enough to establish glutathione-containing products as efficacious “skin whiteners” when tested on healthy volunteers. High quality clinical trials are needed to prove its efficacy as a skin whitener, its dose, how long its effect lasts, and what types of pigmentation it can work well on.3

Is glutathione a safe product for skin whitening? Its safety as a skin whitener has not yet been firmly established. Glutathione products are “generally recognized as safe” (GRAS).4 However, various side effects, ranging from mild to severe, have been linked to glutahione-containing products when used as “skin whiteners”. 6,7   FDA warns against the use of injectable glutathione as a skin whitener because whitening is not an approved use,9  efficacy is not well-established, and there have been reported side effects (acute renal failure, severe drug reactions such as generalized morbilliform eruption with angioedema and urticaria, vasculitis, anaphylactic shock and many documented side effects based on studies on IV glutathione used as skin whitening).6,7,8, 12

Intravenous Glutathione products’ proven and approved use is primarily for medical use ie supportive treatment for chemotherapy patients and NOT for cosmetic purposes. 5,10

The use of any medication should be prescribed and administered by a licensed physician and intended solely for the patient’s greater benefit with significant consideration to their safety and welfare.

The public is advised to be cautious of any marketed product for treating skin conditions (ie skin lightening).

Active pharmacovigilance and public reporting to the DRAP is encouraged. The Public is advised to be alert and report experienced side effects to any glutathione-containing product to DRAP.

 IN THE INTEREST OF PUBLIC SAFETY LET IT BE KNOWN THAT:

• IV GLUTATHIONE IS A DRUG AND NOT MERELY A NUTRITIONAL SUPPLEMENT

• THE UNAPPROVED US OF IV GLUTATHIONE ADMINISTERED FOR SKIN LIGHTENING AT VERY HIGH DOSES IS UNSAFE AND MAY RESULT TO SERIOUS CONSEQUENCES TO THE USERS.

• THE RISK OF HARMFUL SIDE EFFECT INCREASES WHEN NON-PHYSICIANS INJECT GLUTATHIONE

• THE PUBLIC IS STRONGLY WARNED TO REFRAIN FROM USING GLUTATHIONE PRODUCTS THAT ARE NOT FDA-APPROVED AND USED OUTSIDE THE DOSES APPROVED BY FDA

References:

1. Glutathione Metabolism and Its Implications for Health. Guoyao Wu Yun, Zhong Fang Sheng Yang, Joanne R. Lupton and Nancy D. Turner ..The Journal of Nutrition, Volume 134, Issue 3, 1 March 2004, Pages 489- 492,
2. Glutathione, glutathione supplements, and the skin: The basic facts. Author(s): Belen L. Dofitas Journal of the Philippine Dermatological Society. May 2009, Vol 18(1)p. 37-40 (Journal).
3. Glutathione supplements and the skin: An exploratory study and review of the best current evidence. Belen L. Dofitas, Eileen Vizconde.  Journal of the Philippine Dermatological Society, November 2008: Vol. 17(2): p. 98-102 (Journal).
4. Food and Drug Administration, Center of Drug Regulation and Research. Data accessed June 2017 and October 2018. www.fda.gov.ph.
5. Role of glutathione in the regulation of Cisplatin resistance in cancer chemotherapy. Chen HH, Kuo MT. Met Based Drugs. 2010;2010:430939.
6. Glutathione for skin whitening: A systematic review and meta-analysis (Abstract). Toledo, Ma. Socorro and Dofitas, Belen.  Dept. of Clinical Epidemiology, College of Medicine, University of the Philippines Manila, 2016 (unpublished).
7. Glutathione for skin lightening: a regnant myth or evidence-based verity? Sonthalia, Sidharth, Abhijeet K Jha… and Deepak Jakhar. Dermatol Pract Concept. 2018 Jan; 8(1): 15-21. Published online 2018 Jan 31.
8. Efficacy of intravenous glutathione vs. placebo for skin tone lightening. Zubair S, Hafeez S, Mujtaba G. J Pak Ass Dermatol. 2016;26:177–181.
9. Food and Drug Administration. May 12, 2011. Public Advisory.
10. Effects of Glutathione Supplementation: A Systematic Review and Meta-Analysis. Alolod M, Alonte A. and Dofitas B. St. Luke’s Medical Center, Department of Medicine,Metro Manila, Philippines, 2009 (Unpublished).
11. Food and Drug Administration. November 15, 2016. Public Advisory.
12. Adverse effects observed by Filipino-Dermatologists among patients using glutathione containing products: an exploratory study. Asuncion, Eleonor and Dofitas, Belen. Department of Dermatology, St. Luke’s Medical Center 2011.

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