DUBAI 6 June 2017: 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.
By Angel Chan