Table 1 Serious adverse effects included into the benefit-risk assessment, listed alphabetically

Acute severe allergy

Yes

No

Yes

Cardio-pulmonary distress

Yes

Yes

Yes

Diabetes

Yes

Yes

Yes

Gastrointestinal haemorrhage

Yes

Yes

Yes

Hepatotoxicity

Yes

Yes

Yes

Myopathy

No

Yes

Yes

Osteonecrosis

No

Yes

No

Pancreatitis

Yes

No

No

Psychosis

No

Yes

Yes

Seizure

Yes

Yes

Yes

Ventricular arrhythmia/cardiac arrest

Yes

Yes

Yes