Several batches of Naprosyne 1,000 mg are recalled by the ANSM. There is a risk of overdose for visually impaired or blind people linked to a braille transcription error.
- The National Medicines Safety Agency is recalling a non-steroidal anti-inflammatory drug due to a risk of overdose.
- Lots of Naprosyne 1,000 mg have a braille transcription error.
- It is written that these are 500 mg tablets, whereas they are 1,000 mg.
The National Medicines Safety Agency is recalling batches of Naprosyne 1,000 mg. “This recall follows the identification of an error in Braille transcription of the dosage on the secondary packaging: it is mentioned ‘500 mg’ instead of ‘1,000 mg“, she explains in a communicated. This medication is a non-steroidal anti-inflammatory and anti-rheumatic drug based on naproxen: it is prescribed to people over 15 years of age to relieve inflammation around the joints, acute osteoarthritis pain or even acute lower back pain.
A transcription error that can lead to an overdose
This error creates a risk of overdose for blind or visually impaired people. To reduce it, the ANSM is calling on pharmacists. “We ask you to contact, by all means at your disposal, patients likely to have the batches affected by this recall, in order to present to them the reasons and terms of the recall.”alerts the ANSM in its communicated.
Medication recall: what to do if you have a box?
In detail, the Grunenthal laboratory, which manufactures the drug, is recalling 4 batches: No. 237T02, expiry date: 05/31/2025; batch no. 237T03, expiry date: 05/31/2025; batch no. 237T04, expiry date: 05/31/2025; batch no. 238V0, expiry date: 12/31/2025. These are boxes of eight tablets. “If you are blind or visually impaired, we ask you to return the boxes to your pharmacy, even if opened, recommends the ANSM. If your treatment is not completed, consult your doctor to prescribe an alternative treatment or another dosage of Naprosyn.” Those affected will have to wait until the end of October to find boxes of Naprosyn 1,000 mg compliant. Waiting for, “this specialty will no longer be available in pharmacies”underlines the ANSM.
On the other hand, for non-visually impaired people, she explains that there is “no impact”. Indeed, the error in transcription of the dosage only concerns the writing in Braille. “The information mentioned on the box being compliant, you can keep and use your boxes”specifies the agency.
Naprosyne: what are the risks in case of overdose?
In the event of an overdose of Naprosyne, consult a doctor immediately. “Medicines such as NAPROSYNE 1,000 mg tablet could increase the risk of heart attack (‘myocardial infarction’) or stroke.noted there instructions. Taking this treatment may also lead to allergic respiratory skin reactions or angioedema. Digestive disorders, headaches, dizziness, skin reactions to the sun, concentration problems are also possible side effects.
