What is the new warning for lamotrigine?

The New Warning for Lamotrigine

The U.S. Food and Drug Administration (FDA) has issued a new warning for lamotrigine due to the potential contamination with an impurity known as N-nitroso-diethylamine (NDEA). NDEA is a known carcinogen and can be hazardous to human health if ingested. The warning affects all batches of lamotrigine manufactured before December 31, 2021.

What is N-nitroso-diethylamine (NDEA)?

N-nitroso-diethylamine (NDEA) is a known carcinogen and can be hazardous to human health if ingested. It is an industrial chemical that is used in the manufacture of certain products, such as pesticides and dyes.

Studies on the Risks of NDEA

Several studies have been conducted to evaluate the risks of NDEA. A study published in the journal Environmental Health Perspectives in 2011 found that long-term exposure to NDEA can increase the risk of certain cancers, such as liver cancer. A study published in the journal Environmental Science and Technology in 2012 found that NDEA can also increase the risk of reproductive health problems.

The New Warning for Lamotrigine

Due to the potential contamination with NDEA, the FDA has issued a new warning for lamotrigine. The warning affects all batches of lamotrigine manufactured before December 31, 2021. It is important to check with a doctor before taking any medication that may be affected by the warning.


There are various forms of drugs available, such as tablets or liquids, and each may have a separate patient information leaflet (PIL) for different doses. It is important to refer to the PIL for the specific form and dose of the drug that you have been prescribed.

You can search for further information and PILs on websites such as:

  • The British National Formulary (BNF)
  • Electronic medicines compendium (emc)
  • The National Library of Medicine's DailyMed
  • The Food and Drug Administration (FDA) 
  • Different drug forms like tablets or liquids have specific patient information leaflets (PIL) for various doses. Refer to the PIL for your prescribed drug form and dose.

    Search for PILs on websites like:

    France

    • ANSM (Agence nationale de sécurité du médicament et des produits de santé): ansm.sante.fr

    Spain

    • AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): aemps.gob.es

    Germany

    • BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): bfarm.de

    Italy

    For questions about your medication:

    • Consult your doctor, a healthcare professional, or a pharmacist

    France

    • Contact SOS Médecins: 3624
    • For mental health support, contact SOS Suicide: 01 45 39 40 00

    Belgium (French)

    Switzerland (French)

    • La Main Tendue: 143
    • Website: 143.ch

    Canada (French)

    • Centre de prévention du suicide du Québec: 1 866 APPELLE (1 866 277-3553)
    • Website: cpsquebec.ca

    Spain

    • Contact emergency number: 112
    • For mental health support, contact Teléfono de la Esperanza: 717 003 717

    Germany

    • Contact emergency number: 112
    • For mental health support, contact Telefonseelsorge: 0800 111 0 111 or 0800 111 0 222

    Italy

    • Contact emergency number: 112
    • For mental health support, contact Telefono Amico: 199 284 284

    Netherlands

    • Contact emergency number: 112
    • For mental health support, contact 113 Zelfmoordpreventie: 0800 0113

    Portugal

    • Contact emergency number: 112
    • For mental health support, contact Sos Voz Amiga: 21 354 45 45, 91 280 26 69, or 96 352 46 60

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