The UAE Ministry of Health and Prevention has issued a circular to all medical facilities and hospitals to withdraw Brilinta 90 mg batch number JB504 by AstraZeneca, with immediate effect because of wrong packaging. The medicine, which is used by patients who have experienced a heart attack or stroke, has been withdrawn because the packaging contains another drug called Zurampic, Lesinurad, 200mg tablet, also manufactured by AstraZeneca.
Dr. Amin Hussein Al Amiri, Assistant Under-Secretary for Public Health Policy and Licensing Sector of the UAE Ministry of Health and Prevention, and Chairman of the Supreme National Drug Registration, stated that the US Food and Drug Administration, FDA, has issued a warning that the manufacturer has voluntarily withdrawn this batch of the product.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.
The Assistant Under-Secretary clarified that Zurampic is not registered in the Ministry’s Drug Department, however, to ensure the safety of patients, the ministry decided to issue the circular and take the necessary action.
Dr. Al Amiri went on to emphasise 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 concerned health authorities to remove these products and destroy them, ensuring the health and safety of the community.
The public is requested to inform the Ministry of Health and Prevention in case of any side effects from a drug.
MoH warns against taking one lot of Brilinta 90 mg for heart attacks and strokes
The Ministry of Health and Prevention has warned against taking one lot of JB504 of Brilinta 90 mg tablets BRILINTA, which is indicated to reduce the rate of CV death, heart attacks and strokes in patients with acute coronary syndrome (ACS) or a history of heart attack.
The ministry has asked hospitals and medical zones to withdraw the pharmaceutical product from the market.
The ministry said the package also contains another medicine called ZURAMPIC (lesinurad) 200 mg tablet which is also manufactured by AstraZeneca.
Dr. Amin Hussain Al Amiri, Assistant Under-Secretary for Medical Practice and Licence Sector in the MoH, and Chairman of the Supreme Pharmacovigilance Committee, said the US Food and Drug Administration (FDA) issued a warning stating that manufacturer AstraZeneca has voluntary recalled the product saying the unintentional dosing with ZURAMPIC has the potential to lead to adverse renal effects including acute renal failure which is more common when ZURAMPIC is given alone.
BRILINTA has a warning in its prescribing information regarding discontinuation of the medicine. Missed doses of BRILINTA increases the risk of heart attack and stroke.
''The medicine is not registered with the ministry's drug department and the warning was issued as precautionary measures are taken out of concern for the safety of patients,'' he noted.
The ministry is maintaining daily contacts with the FDA, and European and Australian medicines agencies for an update on drug safety alerts.
He requested patients who experienced side-effects with the use of any medicine to fill the online Adverse Reaction form on http://www.cpd-pharma.ae.