Infarmed – National Authority of Medicine and Health Products determined the immediate suspension of the distribution of Lot 24020991 of the Hikma Lacosamide drug, 10 mg/ml, perfusion solution, valid until April 2026. The measure was taken after particle detection detection Visible in the product, which led to Hikma Pharmaceutical (Portugal), I will start a voluntary collection process.
Measures determined by infarmed
The decision was communicated through an informative circular, where the measures to be followed by health entities are specified. According to Infarmed, all units of this lot must be removed from circulation, and its sale, dismissal or administration are prohibited. Entities that have this stock medicine should return.
Regarding patients, infarmed warns that they should not stop treatment on their own. It is recommended that patients seek a doctor or pharmacist to assess the need for replacement with another batch or equivalent medicine.
Lacosamide: What is and what is it for?
Lacosamide is a medicine used in the treatment of epilepsy, indicated for partial epileptic seizures, with or without secondary generalization. It can be administered in isolation (monotherapy) or as an adjuvant therapy, being indicated for adults, adolescents and children from the age of four.
The affected lot refers to the solution version for perfusion, used in a hospital environment or when oral administration is not possible.
Associated risks and precautions
The presence of visible particles in an injectable medicine may pose a risk to patients, as when administered intravenously, they may cause inflammation, blood vessel obstruction or infectious complications.
Despite preventive collection, no cases of adverse reactions associated with this specific lot of Hikma lacosamide were reported.
How to proceed?
Given that this is a hospital drug, health professionals and hospital units are mainly responsible for ensuring the removal and return of the affected lot, as explained.
Patients who are using this medicine should:
- Do not interrupt treatment on its own initiative.
- Consult a doctor or pharmacist To replace the medicine with a safe lot or find a therapeutic alternative.
Infarmed remains to follow the situation and reinforces the importance of continuous surveillance to ensure the safety of medicine available to the population.
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