UAE orders to withdraw drug due to wrong packaging

The UAE Ministry of Health and Prevention has ordered all medical facilities and hospitals to withdraw Brilinta 90 mg batch number JB504 by AstraZeneca, because of wrong packaging. The medicine - used to reduce risks of heart attacks and strokes - is being withdrawn because the package contains another drug called Zurampic (Lesinurad) 200mg tablet, also manufactured by AstraZeneca.

Dr Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licensing Sector of the UAE Ministry of Health and Prevention, and Chairman of the Supreme National Drug Registration, pointed out that the US Food and Drug Administration (FDA) has warned that the manufacturer has voluntarily withdrawn this batch of the product. He said that incorrect doses of Zurampic may lead to renal failure, while sudden discontinuation of Brilinta may increase the risk of heart attack and stroke. He added that Brilinta has been approved by the FDA for the prevention of preventing blood clotting to reduce incidents of cardiovascular death and heart attacks in patients with acute coronary syndrome (ACS).

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He clarified that Zurampic is not registered in the Ministry's Drug Department. However, to ensure the safety of patients, it has been decided to issue the warning and take the necessary action.

Dr Al Amiri emphasized that the Ministry is in regular contact with the FDA and the medicine authorities of Europe and Australia. He said that if any warning is issued regarding any drug, the Ministry immediately takes action and issues a circular to all health authorities concerned to remove these products and destroy them, ensuring health and safety of the community.

You are requested to inform the Ministry in case of any side effects from a drug. Fill in the ADR Side Effects Form which can be downloaded from http://www.cpd-pharma.ae, or write to pv@moh.gov.ae, or call on 971 02 3201448 or fax on 971 02

Source: Khaleej Times