MHRA issues recall of irbesartan blood pressure meds over carcinogen contamination concerns
pharmafile | January 4, 2019 | News story | Manufacturing and Production, Medical Communications | MHRA, irbesartan, pharma, sartan, valsartan
Following a number of recalls issued in the US and Europe in the latter half of 2018 for the blood pressure drug valsartan over fears it had become contaminated with cancer-causing carcinogens, the Medicines and Healthcare products Regulatory Agency (MHRA) has called on pharmacies across the UK to recall blood pressure products containing irbesartan due to similar concerns.
The agency is taking precautionary measures to ensure that patients are not exposed to the medications after it was found that they were possibly contaminated with the carcinogen N‑nitrosodiethylamine (NDEA). The products originate from Accord Healthcare, formerly known as Actavis.
The MHRA said it was working closely with EU member states, the European Mecicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM) to thoroughly investigate the issue and determine what further action may be necessary.
“Our highest priority is making sure the medicines you take are safe,” commented Dr Sam Atkinson, the MHRA’s Director of the Inspection, Enforcement and Standards Division. “Our investigation into potential contamination of sartan containing medicines, including irbesartan, is ongoing. At present, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients. Because of the risk associated with suddenly stopping high blood pressure medication, people are advised not to stop any treatments without consulting their doctor or pharmacist.”
Last year, the agency issued two recalls for medicines containing valsartan; first in July after the impurity N-nitrosodimethylamine (NDMA) was detected in the manufacturing process at a Chinese facility, and again in November, concerning drugs from Mylan and Teva.
Matt Fellows
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