WARNING: Spain issues withdrawal alert concerning popular children’s medication

WARNING: Spain issues withdrawal alert concerning popular children’s medication.

The Spanish Medicines Agency warns that “unknown impurities” have been detected in the drug.

SPAIN’S Agency for Medicines and Health Products (AEMPS) issued a new withdrawal alert on Wednesday, April 20 concerning a popular medication for children due to “unknown impurities” being found in the drug.

The warning is due to defects detected in several batches of Montelukast, which is used to treat childhood asthma and seasonal allergic rhinitis. AEMPS has requested the withdrawal of all affected batches from the market and that they are returned ‘to the laboratory through the usual channels’.

As noted by Diario Sur, Montelukast comes in two well-known chewable tablets used by children: Montelukast Cinfa 4 and Montelukast Cinfa 5. The withdrawal of the Montelukast’s Cinfa 4 and Cinfa 5 comes after AEMPS “obtained out-of-specification results in the test for unknown impurities”.

The alert issued by the AEMPS relates to batches of Montelukast Cinfa 4 mg (batches BS1597, expiry date 31/05/2023) and Montelukast Cinfa 5 mg (batches BR3131, expiry date 31/07/2022; BS0957, expiry date 30/04/2023; BS2137, expiry date 31/08/2023).

The AEMPS establishes three classes of quality defects in medicines when it orders a recall (1, 2 and 3). The first of these corresponds to the highest risk and class 3 to the lowest risk. In this case, a class two defect is targeted.

All autonomous communities have been notified so that their withdrawal can be monitored.

Montelukast

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast improves asthma symptoms, helps control the disease and improves the symptoms of seasonal allergy, also known as hay fever or seasonal allergic rhinitis.

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