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FDA: Intravenous skin whitener potentially deadly

May 12, 2011 3:28pm
Use of the intravenous skin whitener glutathione (Glutathione IV) may be gaining popularity but it may also be inviting potentially serious harm, health officials said Thursday.

The Food and Drug Administration (FDA) cited reports of adverse drug reactions from the use of Glutathione IV, ranging from skin rashes to the deadly Stevens-Johnson Syndrome and toxic epidermal necrolysis.

"The alarming increase in the unapproved use of glutathione administered intravenously [direct into the veins] as a skin-whitening agent at very high doses is unsafe and may result in serious consequences to the health of users," FDA head Suzette Lazo said in FDA Advisory 2011-004.

She said the adverse drug reactions are:
  • Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis;

  • Derangement in the thyroid function;

  • Suspected kidney dysfunction potentially resulting in kidney failure; and

  • Severe abdominal pain in a patient receiving twice-weekly glutathione administered intravenously.
Lazo also said incorrect administration of the substance, especially by untrained people, can result in:
  • Introduction of harmful microorganisms that can result in serious infections including potential fatal sepsis (or inflammation of the whole body);

  • Injection of air can lead to embolism, which is also potentially fatal;

  • Unsafe use of needles (recycling, sharing) can result in the transmission of Hepatitis B and even HIV; and

  • Counterfeiting of glutathione has been reported and may lead ot use of non-sterile preparations that can lead to serious infections.
Glutathione is a compound naturally found in body cells. It is generated by the liver and plays a role in antioxidant defense, metabolism and regulation.

It may have the effect of skin whitening by inactivating the enzyme tyrosinase, which is needed in melanin production and converts the pigment to the lighter phaecomelanin, but Lazo pointed out this claim has been disputed.

"When administered orally, it is hydrolyzed by the gastric juices and further undergoes degradation by the liver enzyme, and the resultant bioavailability is low. Intravenous administration delivers very high doses directly into the systemic circulation and may overload the renal circulation," she warned. — LBG, GMA News



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