A drug for epilepsy and bipolar disorder could cause life-threatening skin rashes, especially in the first two months of treatment, warns the Medicines Agency.
Lamictal® and its genericsmedicines containing lamotrigine (an anticonvulsant) indicated for the treatment of epilepsy and bipolar disorderscould cause severe skin rasheswhich may require hospitalization and lead to deathreports theMedicines Agency (ANSM) in a press release dated July 3, 2023. These adverse effects rare but severe usually occur in the first two months of treatment. Specifically, this includes potentially life-threatening eruptions such as Stevens-Johnson syndromeTHE Lyell’s syndrome (or toxic epidermal necrolysis) and the Dress syndrome (also called drug hypersensitivity syndrome). Rashes may be accompanied by other symptoms such as fever, flu-like symptoms, facial swellingthe appearance of glands, irritation of the mouth or eyes, bruises or unexpected bleeding, a sore throat, lists the ANSM. “This risk of serious rashes is higher in children than in adults“, can we read on the medication leaflet.
What to do if you take Lamictal?
► One patient card is available in the boxes of the medicine to warn you of the risk of serious skin rash associated with lamotrigine. Keep it on you constantly.
► In the event of the appearance of the symptoms mentioned above, consult your doctor immediately or one emergency service.
► Health professionals who prescribe Lamictal or its generics in monotherapy must respect the necessary titration during the first 4 weeks of treatment to reduce the risk of serious skin rash related to lamotrigine. They must immediately report any adverse effect suspected of being due to a medicinal product to their regional pharmacovigilance centre.
► In adultswhen necessary, careful titration is recommended over 6 or even 10 weeks: the initial dosage of lamotrigine should be reduced by half (12.5 mg, i.e. 1 tablet of 25 mg every other day for 2 weeks), then 25 mg/day for 2 weeks, then, depending on clinical response, increase dose in 25 mg increments every 2 weeks until maintenance dose is reached.
► In the childcareful titration is also recommended: the initial dosage of lamotrigine should be reduced by half (0.15 mg/kg/day for 2 weeks) then refer to the recommendations of the summary of product characteristics (SmPC).
► All patients (adults and children) who develop a rash on lamotrigine should be promptly evaluated and lamotrigine should be stopped immediately if its imputability is suspected. In patients who have interrupted treatment due to a rash, the ANSM recommends a specialized dermatological and allergological evaluation, as well as not to reintroduce lamotrigine if the link has been confirmed.
► In case of combination with valproic acid or its derivatives (valpromide, divalproate)the risk of rash is increased due to a pharmacokinetic interaction. This combination is not recommended.
When to take lamotrigine?
► In the treatment of epilepsy:
- As monotherapy or in combination with partial and generalized epilepsiesincluding tonic-clonic seizures in adults and adolescents aged 13 and over
- Seizures associated with Lennox-Gastaut syndrome in adults and adolescents aged 13 years and older
- In combination in partial and generalized epilepsies, including tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome in children and adolescents from 2 to 12 years old
- In monotherapy of typical absences in children and adolescents from 2 to 12 years old
► In the prevention of depressive episodes in adult patients with bipolar disorder I-type (characterized by the presence of at least one manic or mixed episode) and who have a predominance of depressive episodes.
- Lamotrigine: beware of the risk of serious skin rash, particularly at the start of treatment, ANSM, July 3, 2023