Are there any red flags associated with the supplement Neuroshine, which contains pantothenic acid (Vitamin B5) as d-calcium pantothenate, lithium (lithium orotate), bacopa monnieri leaf extract, given the lack of FDA regulation?

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Last updated: June 19, 2025View editorial policy

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From the FDA Drug Label

ADVERSE REACTIONS Lithium toxicity: The likelihood of toxicity increases with increasing serum lithium levels. CONTRAINDICATIONS Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients.

The supplement Neuroshine contains lithium orotate, which is a form of lithium. The FDA drug label for lithium warns of the risk of lithium toxicity, which can occur at serum levels above 1.5 mEq/l. The label also lists several contraindications, including significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion.

  • Key concerns with Neuroshine include:
    • Lithium toxicity: The risk of toxicity increases with increasing serum lithium levels.
    • Contraindications: Patients with certain medical conditions, such as renal or cardiovascular disease, should not take lithium.
    • Interactions: Lithium can interact with other medications, such as diuretics, and increase the risk of toxicity. Given the potential risks associated with lithium, it is essential to exercise extreme caution when considering Neuroshine, especially in patients with pre-existing medical conditions or those taking other medications 1 1.

From the Research

Yes, there are several red flags associated with Neuroshine due to its unregulated status and ingredients, particularly the lithium orotate, which lacks proper safety and dosage guidelines. The supplement contains lithium orotate, which is an unapproved form of lithium that lacks proper safety and dosage guidelines unlike prescription lithium carbonate or lithium citrate 2. The bacopa monnieri extract may interact with certain medications including antidepressants, thyroid medications, and sedatives, potentially causing adverse effects, although recent studies suggest it may have beneficial effects on intracellular signaling processes associated with synaptogenesis and anti-inflammatory effects through NF-κB 3. While vitamin B5 (d-calcium pantothenate) is generally safe at appropriate doses, the combination of these ingredients without FDA oversight means there's no guarantee of consistent potency, purity, or safety across batches. Some key points to consider about Neuroshine include:

  • The potential for adverse interactions with other medications
  • The lack of FDA regulation and oversight
  • The unsubstantiated cognitive enhancement claims made by the manufacturer
  • The need for consultation with a healthcare provider before taking the supplement, especially for individuals with pre-existing conditions, taking medications, or who are pregnant or breastfeeding. Given the most recent and highest quality study available, it is recommended that individuals consult with a healthcare provider before taking Neuroshine, especially those with pre-existing conditions or taking medications 3.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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