Safety Profile

Well tolerated in both acute and chronic therapy.

• Folate augmentation to standard psychotropic medications did not add any additional adverse events acutely or over a 12 month period (age 18-92).^29-35
• Up to 90mg 5-MTHF (45mg L-methylfolate) was administered for 4 weeks without any additional adverse events.³¹
• Deplin® is not contraindicated with any medications.
• Not associated with weight gain, sexual dysfunction, or GI disturbances. ^29-35

Suicide/Overdose

• No suicidal ideation or suicides were reported with folate.^29-35
• Up to a 1,000mg of folate (more than 4 months of Deplin®) was administered for 1-3 weeks in 4 patients with no adverse events reported.³⁶

1. Coppen, A. et al, J. Affective Disorders, 1986
2. Godfrey, PSA., et al. The Lancet, 1990
3. Guaraldi et al. Annals Clinical Psychiatry 1993
4. Passeri, M., et al. Aging Clin. Exp. Res, 1993
5. DiPalma, C, et al. Therapeutic Research, 1994
6. Coppen, A et al. J. of Affective Disorders, 2000
7. Alpert, JE, et al. Annals of Clinical Psychiatry, 2002
8. Carney M., J Nerv Mental Disorders, 1970

Pregnancy

• Up to 1mg of folate is approved by the FDA as Pregnancy Category A.³⁷
• L-methylfolate does not currently have a pregnancy category.

High Dose of Folate May Obscure Ability to Detect Pernicious Anemia

• High doses of folate may normalize the size of enlarged RBCs (megaloblastic) due to a neurological B₁₂ deficiency, masking the diagnostic criteria needed to identify the B₁₂ deficiency.
• If symptoms of anemia occur while taking Deplin, 2mg of B12 is recommended.

37. Folic acid prescribing info, Watson Labs 2005

Drug Interactions

• L-methylfolate is water soluble and rapidly excreted via the kidneys.
• L-methylfolate does not affect CP-450 system.
• Potential Drug Interactions: High dose folate may lower the serum level of first generation anticonvulsants and pryimethamine.

PDR® For Nutritional Supplements, 2001: ISBN: 1-56363-364-7:157-167