Should a levonorgestrel‑releasing Kyleena intrauterine device be removed in a 12‑year‑old female with Down syndrome who developed new‑onset anger outbursts, auditory hallucinations, aggression, and school avoidance one month after insertion, and what further evaluation is recommended?

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Immediate IUD Removal and Urgent Psychiatric Evaluation Required

The Kyleena IUD should be removed promptly in this 12-year-old with Down syndrome who has developed new-onset hallucinations, aggression, and behavioral deterioration one month post-insertion. While the temporal relationship does not definitively establish causation, the severity of psychiatric symptoms—particularly auditory hallucinations and aggressive behaviors—warrants immediate intervention given emerging evidence of psychiatric adverse effects with levonorgestrel-releasing IUDs.

Clinical Reasoning

Psychiatric Adverse Effects of LNG-IUDs

The FDA labeling for Kyleena does not list psychiatric symptoms as contraindications or warnings 1, but recent research reveals concerning psychiatric associations:

  • A 2023 systematic review found that many studies report psychiatric symptoms with LNG-IUDs, predominantly depression, with some evidence of anxiety and suicidality 2
  • A 2018 UK cohort study demonstrated statistically significant associations between levonorgestrel exposure and anxiety (HR 1.18) and sleep problems (HR 1.22) in women without prior psychiatric history 3
  • The systematic review explicitly recommends that "counselling patients about these risks should be mandatory" and that clinicians should be aware of potential depressive symptoms and suicidality 2

Critical Red Flags in This Case

This patient presents with three high-risk features that demand immediate action:

  1. Auditory hallucinations (talking to people who aren't there) - this is a new psychotic symptom
  2. Aggressive behaviors - poses safety risk to patient and others
  3. Severe functional impairment - refusing to leave room or attend school

These symptoms represent a psychiatric emergency, not merely side effects that can be monitored.

Special Vulnerability in Down Syndrome

Adolescents with Down syndrome face unique considerations:

  • They may have limited ability to communicate distress or report subjective symptoms
  • Behavioral changes may be the primary manifestation of psychiatric disturbance
  • The 2024 research on LNG-IUS use in patients with developmental delays found that while these devices are used for menstrual management, complications and patient experience data remain limited 4
  • Interestingly, one study found lower removal rates in patients with intellectual disability (5.7%) 5, but this may reflect communication barriers rather than true satisfaction

Recommended Management Algorithm

Step 1: Immediate Actions (Within 24-48 Hours)

  1. Remove the Kyleena IUD - Do not wait for psychiatric evaluation to be completed

    • The FDA label confirms IUDs can be removed at any time if the patient desires 1
    • Given the severity of symptoms and temporal relationship, removal is the safest course

  2. Urgent psychiatric evaluation to assess for:

    • Psychosis (hallucinations, delusions)
    • Mood disorder (depression, mania)
    • Acute safety risk (self-harm, harm to others)
    • Need for psychiatric hospitalization

Step 2: Rule Out Alternative Causes (Concurrent with Removal)

Before attributing symptoms solely to the IUD, evaluate for:

  • Infection: Check for signs of pelvic inflammatory disease, sepsis, or systemic infection (fever, pelvic pain, discharge) 1
  • Pregnancy: Although unlikely with IUD in place, verify with pregnancy test
  • IUD complications: Assess for perforation, expulsion, or malposition 1
  • Concurrent medical illness: Thyroid dysfunction, metabolic derangements (particularly relevant in Down syndrome)
  • Medication changes: Any new medications started around the same time
  • Environmental stressors: Changes at home or school that preceded symptoms

Step 3: Alternative Menstrual Management

After IUD removal, address the original indication (menorrhagia):

  • Tranexamic acid for heavy bleeding episodes (non-hormonal option)
  • NSAIDs during menses for bleeding reduction and dysmenorrhea 6
  • Consider combined hormonal contraceptives if no contraindications, though these also carry psychiatric concerns
  • Depot medroxyprogesterone acetate (DMPA) is an alternative, though the 2014 AAP guideline notes it's useful for disabled non-ambulatory adolescents requiring menstrual suppression 7
  • However, note that a 2026 study found significantly lower satisfaction with DMPA (50.7%) compared to IUD (96.6%) in adolescents with mental disorders 8

Step 4: Close Follow-Up

  • Monitor psychiatric symptoms weekly for first month post-removal
  • Document timeline of symptom resolution (or persistence)
  • If symptoms persist beyond 2-4 weeks post-removal, this suggests an independent psychiatric disorder requiring ongoing treatment

Critical Pitfalls to Avoid

  1. Do not delay IUD removal while pursuing extensive psychiatric workup - the device can be removed quickly and safely
  2. Do not assume behavioral changes are "just part of Down syndrome" - new-onset hallucinations and aggression require thorough evaluation
  3. Do not restart hormonal contraception without psychiatric clearance and careful discussion of risks
  4. Do not dismiss the temporal relationship - while causation isn't proven, the timing is highly suspicious
  5. Ensure proper informed consent was obtained initially - the FDA label requires counseling about checking threads and recognizing complications 1, but psychiatric effects should also be discussed

Documentation Recommendations

Document clearly:

  • Timeline: When did symptoms start relative to IUD insertion?
  • Baseline: What was her psychiatric/behavioral baseline before IUD?
  • Severity: Specific examples of hallucinations, aggression, functional impairment
  • Decision-making: Who is the legal guardian providing consent for removal?
  • Plan: Psychiatric referral, alternative menstrual management, follow-up schedule

The priority here is patient safety. The combination of new psychotic symptoms, aggression, and severe functional decline in a vulnerable adolescent with limited communication capacity mandates immediate intervention, even if the causal relationship remains uncertain.

References

2
Research

The potential association between psychiatric symptoms and the use of levonorgestrel intrauterine devices (LNG-IUDs): A systematic review.

The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry, 2023

6
Guideline

u.s. selected practice recommendations for contraceptive use, 2024.

MMWR Recommendations and Reports, 2024

7
Guideline

contraception for adolescents.

Pediatrics, 2014

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