Lamotrigine: warning of a risk of serious skin rash

Lamotrigine is a medication prescribed to treat epilepsy and prevent depressive episodes in adult patients with bipolar disorder with a predominance of depressive episodes. In a note published on July 3, the National Agency for the Safety of Medicines and Health Products (ANSM) warns of rare but serious adverse effects of lamotrigine, generally occurring in the first two months of treatment.

Rashes that can lead to death

These are Stevens-Johnson syndrome, Lyell syndrome (or toxic epidermal necrolysis) and Dress syndrome (drug hypersensitivity syndrome with eosinophilia and systemic symptoms). These syndromes include a rash or redness, fever, flu-like symptoms, swelling of the face, lymph nodes, irritation of the mouth or eyes, unexpected bruising or bleeding, and a sore throat. . In rare cases, skin rashes can lead to death, warns the ANSM.

If you experience these symptoms, consult your doctor or emergency department immediately.

To limit the risk of appearance of skin rash linked to taking lamotrigine, the ANSM issues several recommendations for prescribing doctors:

• When lamotrigine is taken alone, respect the dose of medication determined for each patient based on a pre-established efficacy or tolerance objective;
• Avoid combining lamotrigine with valproic acid or its derivatives (valpromide, divalproate);
• In adults, plan a progressive dosage for each patient, over 6 or even 10 weeks (initial dosage reduced by half for 2 weeks, i.e. 12.5 mg/day, then 25 mg/day every 2 weeks until reaching maintenance dosage);
• In children, provide a cautious dosage for each patient (initial dosage reduced by half for 2 weeks, i.e. 0.15 mg/kg/day).

What to do if a rash breaks out?

All patients who develop a rash while taking lamotrigine should see their doctor promptly. Only a doctor may consider it necessary to stop treatment if he or she suspects a link between the medication and the rash. Patients who have stopped treatment must undergo a specialized dermatological and allergological evaluation and not resume lamotrigine.

Finally, the ANSM invites all healthcare professionals to report any adverse effects suspected of being linked to taking a medication to a regional pharmacovigilance center.