New tablets of Neofordex, a corticosteroid medicine used in the treatment of certain cancers, are marketed in France from May 15, 2023 and are linked to a risk of medication error. Patients need to be very careful…
Patients and healthcare professionals should take particular care as there is a risk of medication error with Neofordex® 40 mg, a medicine containing dexamethasone, alert theMedicines Agency (ANSM) in a press release dated April 24, 2023. This drug is indicated, in combination with other drugs in adults with symptomatic multiple myeloma, a type of cancer affecting certain white blood cells. Attention, from May 15, 2023 and for a period of about two months, two different tablets will coexist: old tablets and new tablets. The old tablets have a score line allowing them to be cut in half and made into two tablets of 20 mg each. Problem: the half of the tablet that is not used must be discarded (out of its packaging, half has been in contact with the ambient air and its perfect effectiveness is no longer guaranteed). The new tablets will no longer have this breakbar and should not be cut in half at the risk of getting the dosage wrong. To avoid the risk of error, the new boxes will have a yellow sticker with the mention “Warning – unscored tablets” on their main face to clearly differentiate them from boxes containing scored tablets. In addition, the indication “40 mg” will be engraved on one of the faces of the new tablet.
What are the indications for Neofordex?
Neofordex® is a medicine marketed by the CTRS laboratory which has the active substance dexamethasone, a synthetic (gluco)corticoid that has an anti-inflammatory and immunosuppressive effect. This medicine is used to treat adult patients with symptomatic multiple myeloma, blood cancer affecting the white blood cells that produce the antibodies, together with other medicines to treat multiple myeloma. It acts on the body by preventing white blood cells from attacking healthy tissue, which decreases inflammation and the proliferation of cancer cells. It is a medicinal product subject for hospital prescription (list I), a prescription reserved for specialists in oncology or hematology, or doctors competent in oncology or blood diseases. It requires special monitoring during treatment
What precautions for patients?
→ Patients do not should never cut a Neofordex tablet® which features the engraving 40 mg and which does not have a break line (center line in the middle)
→ Patients should keep their tablets Neofordex® in their original blister until use.
→ The doctor decides the dose and the frequency of intake, which may vary according to the pathology and the other associated treatments. In general, the usual dose of Neofordex® is 40 mg once a day, but the dosage and frequency of intake vary depending on the other drugs being given and the condition of the patient. Some patients may be prescribed only half a tablet (20 mg). Note that for dosages below 40 mg, there are other dexamethasone-based drugs.
| Old Neofordex® 40 mg tablet | New Neofordex® 40 mg tablet (from May 15, 2023) |
|---|---|
| Comes with a score line to split them in half (two halves of 20mg each) | No score line (one 40mg tablet only) |
What precautions for health professionals?
If the dosage indicated for patients is less than 40 mg of dexamethasone, in particular for elderly and/or fragile patients, at the end of treatment or in situations where this is required by the therapeutic protocol, it is recommended to prescribe other dexamethasone-based specialties. In France :
- Pharmaceutical preparations of dexamethasone capsules can be produced at different dosages, in particular 6, 10 and 20 mg.
- The specialty Dexliq® 4mg/ml oral solution will soon be marketed.
Sources:
– Neofordex 40 mg (dexamethasone): beware of the risk of medication error with the new tablet without a score line, ANSM, 24 April 2023
– Public drug database
– Neofordex, INN-dexamethasone, European Medicines Agency (EMA)