The American Glaucoma Society (AGS) and the American Academy of Ophthalmology (AAO) have issued a cautionary statement regarding the use of nicotinamide (a derivative of vitamin B3) as a potential therapy for glaucoma neuroprotection. While it shows promise for protecting the optic nerve, concerns about its safety—particularly the risk of drug-induced liver injury (DILI)—make careful use essential.
What Is Glaucoma and Why Is Neuroprotection Important?
Glaucoma is a leading cause of irreversible blindness, projected to affect 111.8 million people by 2040. While current treatments focus on lowering intraocular pressure (IOP), many patients still experience optic nerve damage and vision loss. This highlights the urgent need for neuroprotective agents like nicotinamide to slow damage to retinal ganglion cells and potentially promote recovery.
What Is Nicotinamide and Its Potential Role in Glaucoma?
Nicotinamide has shown potential as a neuroprotective agent in both laboratory and human studies. However, its long-term safety and effectiveness are still under investigation. The AGS-AAO statement, published in Ophthalmology Glaucoma, outlines key recommendations for its cautious use:
- Approval Status:
- Nicotinamide is not approved for glaucoma treatment.
- Patients should only consider doses below 3 grams/day under medical supervision, with regular liver function tests.
- High-Dose Warning:
- Doses of 3 grams/day or more should only be used in clinical trials with close monitoring to prevent liver damage.
- Side Effect Reporting:
- Patients should report any side effects to their physician or clinical trial investigators and use the FDA Safety Reporting Portal for transparency.
- Contraindications:
- Nicotinamide is not recommended for patients with current or prior liver disease.
- Niacin Is Not Nicotinamide:
- While niacin is related to nicotinamide, it is not interchangeable. Niacin is known to be hepatotoxic at high doses and is not being evaluated for glaucoma neuroprotection.
The Risks of High-Dose Nicotinamide
High doses of nicotinamide can lead to drug-induced liver injury (DILI). Experts stress that patients should:
- Consult their primary care providers before using nicotinamide.
- Undergo periodic liver function testing.
- Avoid self-administering high doses without medical oversight.
Expert Insights
Expert from the Edward S. Harkness Eye Institute emphasized that even doses below 3 g/day require physician consultation and monitoring. For doses of 3 g/day or more, strict clinical trial supervision is essential due to the risk of serious liver damage.
The AGS and AAO have warned against unsupervised use of nicotinamide supplements, particularly given the high prevalence of dietary supplement use and the potential for unreported adverse effects.
Balancing Potential Benefits with Safety
While nicotinamide shows promise as a neuroprotective agent, ensuring patient safety is paramount. Collaborative care between patients and physicians, along with rigorous monitoring, is necessary to balance its potential benefits with the risks of liver toxicity.
Key Takeaways
- Nicotinamide is not yet approved for glaucoma treatment.
- High doses pose significant risks of liver injury.
- Patients considering its use should always consult their doctor and follow safety guidelines.
- Ongoing research is needed to better understand its role in glaucoma management.
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