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Bipolar disorder - Management
What are the adverse effects of lamotrigine?

  • Skin rash:
    • All people (adults and children) who develop a rash should be promptly evaluated and lamotrigine withdrawn immediately unless the rash is clearly not drug related.
    • Rash has been reported in up to 10% of people taking lamotrigine in clinical trials. These rashes were maculopapular in appearance, generally appeared within 8 weeks of starting treatment, and resolved on withdrawal of lamotrigine.
    • Serious, potentially life threatening, skin rashes, including Stevens–Johnson syndrome and toxic epidermal necrolysis (Lyell Syndrome) have been reported. The approximate incidence of serious skin rashes reported as Stevens–Johnson syndrome in adults and children older than 12 years of age is 1 in 1000. Children younger than 12 years of age are at higher risk. Available data from a number of studies suggest that the incidence in children younger than 12 years of age requiring hospitalization due to rash ranges from 1 in 300 to 1 in 100.
    • In children, the initial presentation of a rash can be mistaken for an infection; clinicians should consider the possibility of a drug reaction in children that develop symptoms of rash and fever during the first 8 weeks of therapy.
    • Factors associated with increased risk of serious skin reactions include:
      • Concomitant use of valproate, initial lamotrigine dosage higher than recommended, and more rapid dose escalation than recommended.
      • Rash is sometimes associated with hypersensitivity syndrome and is more common in people with a history of allergy or rash from other antiepileptic drugs.
  • Other adverse effects reported include headache, tiredness, nausea, dizziness, drowsiness and insomnia, diplopia, blurred vision, conjunctivitis, gastrointestinal disturbance (including vomiting and diarrhoea), irritability or aggression, tremor, agitation, confusion, and hallucinations.
  • Rarely reported adverse effects include:
    • Hypersensitivity syndrome: rash, fever, lymphadenopathy, hepatic dysfunction, blood disorders, disseminated intravascular coagulation, and multiorgan dysfunction.
    • Blood disorders: leucopenia, thrombocytopenia, pancytopenia.
    • Lupus-like reactions.
  • There is a small risk of suicidal thoughts and behaviour, which may be seen as early as one week after starting treatment [MHRA, 2008b].
    • People taking lamotrigine and healthcare professionals should be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment.

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