A preliminary assessment by the European Medicines Agency in relation to recalled valsartan medicines (PD 11 Jul) has estimated there could be one extra case of cancer for every 5,000 patients taking the affected drugs at the highest dose (320mg) every day for seven years.
The evaluation is based on average levels of the carcinogenic NDMA impurity detected in the active substance from Zhejiang Huahai Pharmaceuticals.
Companies that had used the Zhejiang Huahai active substance are requried to test their valsartan medicines to determine the actual NDMA levels in the final products.
All of the impacted drugs have been recalled in the UK, EU and US but the EMA said it was important to note there was no immediate risk to patients and that other non-impacted valsartan medicines continue to be available.
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