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FDA Backs Glutathione Ban

FDA Backs Glutathione Ban
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The threat to this critical medicine deepens. We have to act fast to protect glutathione. Action Alert!

Ahead of the June 8th meeting of an FDA advisory committee, the FDA has released its own recommendation for whether glutathione should be permitted to be made at specialized pharmacies for individual patients—and the news isn’t good. The agency has recommended that compounded glutathione be banned from pharmacy compounding. We need to work fast to make sure the FDA and its committee knows that patient health will be harmed if we do not have access to compounded glutathione.

In its materials released ahead of the June 8th meeting of its Pharmacy Compounding Advisory Committee (PCAC), the FDA explains its reasoning for backing a ban on compounded glutathione. The FDA cites safety issues with glutathione, including hepatoxicity, or damage to the liver. Huh? Is the FDA aware that n-acetylcysteine (NAC), which tells the body to make glutathione, is the standard treatment for acetaminophen poisoning—which causes liver injury? What is the FDA thinking?

The FDA doesn’t appear to be concerned about the common drugs on the market that can also lead to liver injury, like many antibiotics (amoxicillin-clavulanate, flucloxacillin, sulfamethoxazole/Trimethoprim, and erythromycin) and NSAIDs (diclofenac, Ibuprofen). In fact, the FDA has an entire database of drugs known to cause liver injury with over 1,000 entries.

This exposes what a sham the FDA’s process is. The precursor to glutathione is used to treat drug-induced liver injury in hospitals, and glutathione is being banned…because it damages the liver? It doesn’t pass the sniff test. This supports our theory from the start: the FDA is doing whatever it can to protect drug industry profits. We reported previously on the wide range of uses for glutathione—and that’s the problem. Because it is so useful for such a variety of conditions, it competes with and threatens the financial viability of lots of different drugs. Here comes FDA, once again, to save Big Pharma’s bacon and the expense of patients.

We need a strong response from patients to show the FDA and PCAC that people care about and need access to this medicine. We encourage advocates to add a personal story if you have one when filling out the action alert below

Action Alert! Use the form below to post a message to regulations.gov defending glutathione; you will also send a message to the FDA, PCAC, and Congress. Please send your message immediately.

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