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: