Anti-inflammatory drug recalled in France over dosage labelling error

It means the drug may not be available in pharmacies until the end of October

A view of a medicine bottle labelled naproxen
Naprosyne is the brand name of the recalled drug, which is the painkiller naproxen. The 1,000mg drug boxes are incorrectly labelled in braille
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An anti-inflammatory drug is temporarily unavailable in France after being recalled due to a labelling error that could lead to a risk of overdose.

The drug concerned is called Naprosyne (the brand name). It is the painkiller naproxen, and is issued in boxes of eight 1,000 mg tablets, marketed by Laboratoires Grünenthal.

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for pain, including that caused by osteoarthritis, tendonitis, lower back pain, rheumatism, or menstruation.

Why has the drug been recalled?

The French drug safety agency l'Agence du médicament (ANSM) has now recalled recent batches of the drug due to a problem with the braille on the boxes. The non-braille text is correct, but the braille incorrectly identifies the tablets as ‘500mg’ instead of ‘1,000 mg’.

This could lead to people who read the braille taking double the medication they need.

All patients are advised that batches with the incorrect braille have been recalled and new batches will not arrive in pharmacies until the end of October.

The ANSM has asked pharmacies to contact patients who are “likely to be in possession of the batches concerned by this recall, by any means at your disposal, to inform them of the reasons for and details of the recall”.

Which boxes are affected?

The batches concerned are as follows:

  • Batch number 237T02 / Expiry date: 31/05/2025
  • Batch number 237T03 / Expiry date: 31/05/2025
  • Batch number 237T04 / Expiry date: 31/05/2025
  • Batch number 238V01 / Expiry date: 31/12/2025

What if I have one of the boxes affected?

People who are blind or partially sighted and rely on the braille on your medicine boxes should return any boxes of Naprosyne - opened or not - to their pharmacy. If their treatment has not ended, they are advised to consult their doctor so as to be given an alternative or different dosage of the drug.

If you are not blind or partially sighted, you are welcome to keep your boxes. The information printed on the box (all non-braille text) is correct.

What if I cannot get hold of my prescription Naprosyne?

If your doctor prescribes you Naprosyne and it is unavailable at pharmacies as a result of the recall, you can ask them to prescribe you an equivalent alternative until the drug becomes available again at the end of October.

The pharmacist may also be able to advise you on this.

What are the risks of an overdose?

If you accidentally take too much naproxen, you are advised to stop all treatment and consult a doctor immediately.

Side effects can include digestive problems (nausea, vomiting, bloating, diarrhoea, constipation, stomach pains, gastrointestinal discomfort, and more rarely, inflammation of the intestine), headaches, dizziness, high blood pressure, palpitations and muscle weakness.

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