In this newsletter, we discuss the recent warning issued by the FDA about the potential health risks associated with using ketamine products in treating an array of psychiatric disorders.
We also discuss the efficacy of broad-spectrum micronutrient (BSM) supplementation for psychiatric disorders, key points from a presentation on the use of natural medication, and our practical research summaries of adult, child, and adolescent psychiatry (Quick Takes and CAP Smart Takes).
FDA Issues Warning on Compounded Ketamine Products
On October 10, 2023, the FDA released a cautionary statement concerning the potential health hazards linked to the use of ketamine products in treating diverse psychiatric disorders. This advisory was issued because the agency had not yet approved its use for any psychiatric disorder. This incident was not isolated; the FDA has previously raised concerns about ketamine nasal spray.
- How does the FDA categorize ketamine?
- Ketamine falls under the Schedule III classification of controlled substances.
- Although it is recognized for its medical use, misuse of substances like ketamine could result in moderate-to-low physical dependence or high psychological dependence.
- What are the FDA-approved uses for ketamine?
- Ketamine is approved as an intravenous or intramuscular injection solution for induction and maintenance of general anesthesia.
- Has the FDA approved any form of ketamine for mental health conditions?
- In 2019, the FDA endorsed a nasal spray variant of ketamine known as esketamine (Spravato) for treating adults with treatment-resistant depression (in conjunction with an oral antidepressant).
- Currently, esketamine can only be accessed through a controlled system, the Risk Evaluation and Mitigation Strategy.
- Why hasn’t the FDA approved alternative ketamine compounds for psychiatric disorders?
- The FDA has not yet evaluated the safety, efficacy, and quality of ketamine and related compounds for specific psychiatric applications.
- Currently, there is no evidence to suggest that ketamine and related compounds are safer, more effective, or faster acting than existing FDA-approved medication for treating psychiatric disorders.
- What potential safety hazards could be linked to compounded ketamine products?
- Sedation, dissociation, exacerbation of existing psychiatric disorders or onset of new psychiatric events, the possibility of abuse and misuse, elevation in blood pressure, respiratory depression, as well as lower urinary tract and bladder symptoms
- What are the main concerns for the FDA issuing this alert?
- Inconsistent dosages of sublingual and oral compounded ketamine products promoted by compounders and telemedicine platforms
- Inadequate monitoring of adverse side effects
- Potential omission of crucial information regarding product-related risks
- Insufficient data on the usage of these products
In conclusion, it is prudent to exercise caution when utilizing or recommending ketamine and related compounds for psychiatric disorders. It is essential to acknowledge the concerns surrounding inconsistent dosages, inadequate monitoring of side effects, omitted risk information, and insufficient data on usage. Learn more here.
BSMs in Psychiatry With Amelia Villagomez, M.D.
In this interview, Dr. Amelia Villagomez presents relevant research on the efficacy of BSM supplementation for the management of selected psychiatric conditions, such as emotion dysregulation in ADHD. She also provides practical guidance on initiating BSM supplementation and offers personal insights based on her clinical experience in the field.
Interview highlights include the following:
- BSMs may be considered as a second- or third-line agent for the management of ADHD; they have also been found to be helpful for the management of emotion dysregulation.
- Although a trial of BSMs may be justifiable given their safety, cost, and potential benefits, initiating BSMs begins with a discussion of patient preferences and goals.
Learn more and earn 0.5 CME credits here.
Natural Medication in Psychiatry: Focus on Versatile Agents and Combination Strategies
In this video lecture, Dr. Mischoulon delves into the use of natural medication for psychiatric disorders. He highlights the therapeutic benefits of N-acetyl-cysteine for mood disorders and sheds light on the promising applications of inositol, cannabidiol, and ashwagandha. Concluding the lecture, he provides a compelling overview of the potential combinations of these natural remedies and offers guidance on maximizing their efficacy in psychiatric care.
Potential Combinations of Natural Medication for Psychiatric Disorders
- When a patient does not respond to a single medication, combination therapy can be attempted.
- Many natural remedies can be combined to target comorbid conditions.
- Be cautious when combining St. John’s wort with other medication.
Learn more and earn 0.75 CME credits here.
Quick Takes: Research, Digested
Neonatal and Pregnancy Complications Following Maternal Depression or Antidepressant Exposure
- Mothers with depression but without antidepressant exposure had higher risks of complications, like intrauterine growth restriction and preterm delivery.
- Antidepressant exposure during different trimesters of pregnancy resulted in varied risks for certain complications, highlighting the importance of timing when considering medication management.
- The overall implication is that withholding antidepressants might pose a more significant risk, emphasizing the importance of a comprehensive risk–benefit analysis in clinical decisions. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
CAP Smart Takes: Research, Digested
Addition of Fish Oil to Cognitive–Behavioral Case Management for Youth Depression
- The study examined the potential benefits of fish oil (specifically n-3 PUFAs) as an adjunct to cognitive–behavioral therapy in treating adolescents and young adults with major depressive disorder.
- No significant difference was observed in depressive symptoms, indicating that fish oil may not enhance treatment response in this age group.
- Both groups exhibited similar adverse event rates, suggesting that fish oil supplementation is well-tolerated. Learn more.
Listen to or read the full volume, and earn 0.5 CME credits here.
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References
- FDA warns about compounded ketamine for psychiatric disorders. (2023, October 10). https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine
