The Medicines and Healthcare Products Regulatory Agency (MHRA) has recalled three additional batches of Irbesartan today as part of a continuing investigation into a potential N nitrosodiethylamine (NDEA) contamination.
These sartan containing medicines belong to a class of drugs used to treat blood pressure, heart attack, and heart failure. There is currently no evidence that NDEA impurity can cause harm and patients are being advised to continue taking their medication.
Previous Recalls
The MHRA had begun an investigation in 2018 after another impurity, N-nitrosodimethylamine (NDMA), was found in a valsartan active substance manufactured in a facility based in China, leading to recalled batches of valsartan last July and November due to possible NDMA contamination.
Testing then revealed possible NDEA contamination, and the MHRA recalled batches of Irbesartan made by Actavis Pharm UK Limited in early January 2019. The MHRA Irbesartan recall widened in late January 2019 to include batches made by Macleods Pharma UK.
Latest Recalls
The MHRA has been continuing to monitor the situation and its investigation uncovered more affected products. Working with pharmacies, it has announced the recall of another three batches of Irbesartan, all manufactured by Actavis Pharma UK Limited:
- Irbesartan 300mg film-coated tablets, PL 30306/0108; batch number 191018, expiry date 05/2020, pack size 1 x 28; first distributed 30th Nov 2018
- Irbesartan 300mg film-coated tablets, PL 30306/0108; batch number 191118, expiry date 05/2020, pack size 1 x 28; first distributed 20th Dec 2018
- Irbesartan/Hydrochlorothiazide 300/25mg film-coated tablets, PL 30306/0267; batch number 263918, expiry date 06/2020, pack size 1 x 28; first distributed 21st Nov 2018
Advice for Healthcare Professionals
The MHRA has provided the following advice to both wholesalers and healthcare professionals:
- Stop supplying the batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
- If you receive queries about this issue from patients, advise them to continue taking their medication as the health 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.
- Shortages of Irbesartan-containing products are not anticipated. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments.
The MHRA is continuing to investigate the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM), and say they will continue to monitor the situation in the UK.
Dr Sam Atkinson, MHRA's director of the inspection, enforcement and standards division, has assured "there is no evidence at present that medicines containing NDMA or NDEA have caused any harm to patients" and noted that the recall is occurring as a precaution.
He said: "Patient safety is our top priority and we will take any necessary steps to protect public health. Today's Irbesartan recall shows we are continuing to investigate potential contamination of sartan containing medicines."
