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Table 1 Summary of the various AEMPS safety alert criteria

From: Impact of a system to assist in clinical decision-making in primary healthcare in Catalonia: prescription Self Audit

Drug

Alert criteria

Citalopram

High doses:

 Above 40 mg/day

 Above 20 mg/day in patients > 65 years of age

 Above 20 mg/day in patients suffering from liver dysfunction

Administered in combination with other drugs that also prolong the QT interval of the electrocardiogram

Escitalopram

High doses (> 10 mg/day in patients > 65 years of age)

Administered in combination with other drugs that also prolong the QT interval of the electrocardiogram

Aliskiren

In patients with a diagnosis of diabetes mellitus II or undergoing treatment with antidiabetic drugs

Jointly administered with ACE inhibitors

Cilostazol

In patients suffering from a health problem where its use is contraindicated, i.e., cerebral haemorrhage, severe ventricular arrhythmias, or heart failure

Or, in concomitant treatment with:

 2 Antiplatelet agents

 Antiplatelet + oral anticoagulant

Trimetazidine

In patients with a diagnosis of extrapyramidal and movement disorders

Raloxifene or bazedoxifene

In patients suffering from any health problem where it is contraindicated, e.g., venous thromboembolism, uterine sac, endometrial cancer, or liver failure of any degree

COXIBS

In patients suffering from any health problem where it is contraindicated, e.g., ischemic heart disease, peripheral arterial disease, cerebrovascular disease, heart failure, or inflammatory bowel disease

Diclofenac or Aceclofenac

In patients suffering from any health problem where its use is contraindicated, e.g., ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or heart failure

Agomelatine

In patients ≥ 75 years of age

Ivabradine

Co-administration with verapamil

“Triple Whammy” (NSAIDs + RAS inhibitors + diuretics)

In patients ≥ 75 years of age or undergoing treatment for diabetes

Canagliflozin

In patients suffering from a health problem in which it is necessary to be more careful due to an increased risk of amputation