Letters and drug alerts sent to healthcare professionals in February 2019
Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone). Alerts were issued about irbesartan, amoxicillin, atropine sulfate, and paracetamol infusion.
Letters
The following letters were sent to healthcare professionals in February 2019:
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; provide English-language patient information leaflets with imported Nordic batches
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OZURDEX 700 micrograms intravitreal implant (dexamethasone): Update on silicone particle issue: Supply of new (defect-free) stock and recall of remaining stock in the market
Irbesartan recall
You should also be aware of a European-level recall from pharmacies of certain batches of Actavis irbesartan-containing products as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA). See the recall notice on the MHRA website (issued 13 February 2019).
Advice for healthcare professionals:
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stop supplying the affected products/batches listed immediately; quarantine all remaining stock and return it to your supplier using your supplier’s approved process
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advise patients not to stop taking their medication as the risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment
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although shortages of irbesartan-containing products are not anticipated, there may be some local supply issues – should this be the case, patients should be advised to speak to their doctor to discuss alternative treatments
The MHRA continues to thoroughly investigate the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM). We will continue to monitor the situation in the UK and consider what actions are necessary to protect public health. Subscribe to MHRA drug alerts for updates.
Other drug alerts
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Class 4 defect information: Amoxicillin 500mg Capsules BP (MDR 92-12/18). Issued 4 February 2019. A change to the Patient Information Leaflet (PIL) for this product has not been implemented by the required timeline. The change concerns the addition of the symptoms of a potential side effect, ‘Drug Reaction with Eosinophilia and Systemic Symptoms’ (DRESS), which is a potentially life-threatening condition. If dispensing a batch listed in the alert, healthcare professionals are requested to remove the PIL in the pack and provide a copy of the correct version, which can be downloaded here.
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Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19). Issued 18 February 2019. There is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3 mg/10 ml Solution for injection in pre-filled syringe.
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Drug Alert Class 4: Paracetamol Infusion, Accord. (MDR 07-02/19). Issued 28 February 2019. There is an error on the portion of the Patient Information Leaflet (PIL) for the Paracetamol Infusion intended for healthcare professionals. This error relates to an unmarketed presentation in the UK. The corrected PIL can be accessed here.
Article citation: Drug Safety Update volume 12, issue 8: March 2019: 4.