Medicines recall drug alert issued for potentially contaminated ranitidine products
Pharmacists are being advised to stop supplying some ranitidine (Zantac; GSK) products after it was revealed that they may be contaminated with the impurity N-nitrosodimethylamine (NDMA).
On 8 October 2019, the Medicines Healthcare products Regulatory Agency (MHRA) issued a Class 2 medicines recall drug alert for all unexpired stock of four products: Zantac syrup (150mg/10mL), Zantac injection (50mg/2mL), Zantac tablets (150mg) and Zantac tablets (300mg).
This is a precautionary measure as NDMA is a probable human carcinogen.
Pharmacists and pharmacy teams are required to stop supplying the affected products immediately, and quarantine and return all remaining stock of these products to their supplier using their agreed process.
However, patients should be advised not to stop taking their medicines as stopping treatment could pose more of a health risk than the contaminant that may be present. The MHRA also confirmed that a treatment review was not necessary until the patient’s next routine appointment.
Ranitidine medicines, which belong to a class of medicines known as histamine-2 blockers, are used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. They are available over-the-counter and on prescription.
The European Medicines Agency (EMA) announced that it would start a review of ranitidine medicines in September 2019 after tests revealed some products could contain the impurity. In 2018, NDMA and was also found in several blood pressure medicines, known as ‘sartans’, leading to recalls and an EU review.
The MHRA is working with the EMA on this issue and an investigation into other potentially impacted products is continuing.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20207180
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