THE Spanish Health System has withdrawn medication to treat hypertension after N-nitrosamines2 was reportedly detected in certain batches.
The Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, Consumption and Social Welfare, has ordered the withdrawal of Irbesartan medicines for hypertension containing the active substance N-nitrosamines 2.
The substance also caused the drug valsartan to be withdrawn from sale last July over concerns it could cause cancer and the EU banned this particular medication in November.
After additional health controls were put in place for all the medicines of the group called ‘sartanes’, the N-nitrosamines2 component has been detected in certain batches of the active substance Irbesartan manufactured by the Chinese company Zhejiang Huahai Pharmaceutical.
The Chinese company manufactures drugs that are marketed in European countries, including Spain.
Consequently, the AEMPS has ordered the withdrawal of the lots of medication from two companies, Aurovitas Spain and Glenmark Arzneimittel Gmbh.
Consumers using this medication have been recommended to go to their local pharmacy with the affected dose and request a replacement.
The affected batch, Aurovistas Spain, lot number 149918 of the drug Rbesartan / Hydrochlorothiazide Aurovitas Spain 300 mg / 25 mg film-coated tablets has been removed.
And from Glenmark Arzneimittel Gmbh, the EIZ805A lot from Irbesartan Viso Pharmaceutical 150 mg tablets coated with EFG film; lots EIA1808A and EIA1809A of Irbesartan Viso Pharmaceutical 300 mg film-coated tablets EFG; and the batches EIA3801A, EIA3802A and EIA3803A of Irbesartan / Hydrochlorothiazide Viso Pharmaceutical 150 mg / 12.5 mg film-coated tablets EFG.