Safety Assessment of Magnesium Glycerophosphate 8,000mg with Pyridoxine HCl 830mg
The combination of Magnesium glycerophosphate 8,000mg and Pyridoxine HCl 830mg is not safe due to the extremely high dose of Pyridoxine (Vitamin B6) which far exceeds established safety limits and poses significant risk of peripheral neuropathy.
Vitamin B6 (Pyridoxine) Toxicity Concerns
- The European Food Safety Authority recommends an upper tolerable intake level of only 100 mg/day for adults over 19 years 1
- The proposed dose of 830mg pyridoxine HCl is more than 8 times the established safety threshold and presents a high risk for toxicity 1, 2
- Vitamin B6 toxicity primarily manifests as sensory neuropathy that can progress to motor involvement in severe cases 2
- Clinical signs of pyridoxine toxicity include sensory neuropathy with ataxia, areflexia, impaired cutaneous and deep sensations, and dermatologic lesions 3
- Long-term doses as low as 100 mg/day have been associated with Lhermitte signs, suggesting effects on the spinal cord 3
Magnesium Considerations
- The safety of magnesium glycerophosphate at 8,000mg is difficult to assess without knowing the elemental magnesium content 4
- Magnesium supplementation should be used with caution in patients with impaired renal function 4
- Hypermagnesemia can occur with excessive magnesium intake, particularly in those with reduced renal clearance 4
Interaction Between Magnesium and Vitamin B6
- While vitamin B6 and magnesium can work synergistically at appropriate doses, the extremely high dose of pyridoxine in this combination overshadows any potential benefits 5
- Research has shown that only very high doses of vitamin B6 (1-1.5g/day) increase erythrocyte magnesium, but these doses are associated with reversible neurological complications 5
- There have been reports of hyperactivity in children with autism spectrum disorder when treated with pyridoxine and magnesium combinations 6
Clinical Recommendations
- For therapeutic purposes, pyridoxine supplementation should generally not exceed 50-100mg daily 3
- For patients taking medications like isoniazid, pyridoxine supplementation at 25-50 mg/day is recommended, increasing to 100 mg/day only if peripheral neuropathy develops 1, 2
- If supplementation is needed, consider significantly lower doses of both compounds:
Management of Vitamin B6 Toxicity
If a patient has already been taking this high-dose combination:
- Immediately discontinue all vitamin B6 supplements 2
- Obtain baseline neurological assessment to document the extent of neuropathy 2
- For neuropathic pain, consider pregabalin 150-600 mg/day or gabapentin 300-2,400 mg/day 2
- Be aware that recovery may take several weeks to months, and some nerve damage may persist 2
This combination presents significant safety concerns primarily due to the extremely high dose of pyridoxine, which far exceeds established safety thresholds and creates an unacceptable risk of peripheral neuropathy.