Dubai: The Ministry of Health and Prevention has issued a circular ordering the recall of some hypertension medicines containing the active ingredient Valsartan.
The medicines, manufactured by Chinese company Zhejiang Huahai Pharmaceutical, were recalled after the detection of impurities in the active ingredient, the ministry said.
The ministry’s action follows a report by the European Medicines Agency indicating contamination of the active ingredient with N-nitrosodimethylamine (NDMA), a chemical that might cause cancer.
Valsartan is used in the treatment of hypertension to prevent related cardiovascular complications.
The circular has been addressed to directors of medical districts, public and private hospitals, doctors, pharmacists and assistant pharmacists, and directors of government and private pharmacies.
The recall order has been sent to authorised agents and distributors of the recalled products with an order to quarantine all quantities of the products present within their warehouses. It has also directed that all health care practitioners and doctors should not prescribe or dispense the affected products and also advises patients to not discontinue use of the medicine unless they consult with the doctor to prescribe other alternatives registered with the ministry.
The ministry explained that other medicines, which are manufactured using the same active ingredient from other sources, are safe to use.
Swiss multinational pharmaceutical company Novartis informed the ministry that their products containing Valsartan — Diovan, Co-Diovan Entresto and Exforge — are not impacted because these products do not contain Valsartan from an external supplier. The active ingredient was manufactured in a Novartis site in Ireland and Switzerland.
The recall was issued after them ministry’s senior officials reviewed Ministerial Resolution No 366 of 2010 governing the withdrawal, suspension, or prevention of distribution of pharmaceutical and medical products to protect public health. The circular includes a list of affected products that have been registered with the ministry’s drug department.