European Union - The following Position Statement has been published by the Committee for Proprietary Medicinal products (CPMP) on use of fibrinolytics in diabetic patients.
Intravenous (iv) fibrinolytic agents are indicated for the treatment of acute myocardial infarction (AMI). Patients with diabetes mellitus are at an increased risk of AMI and subsequent morbidity and mortality, and thus clearly stand to benefit from fibrinolytic treatment. All i.v. fibrinolytic treatments currently licensed in the EU nonetheless include a contraindication or warning regarding use in patients with diabetic haemorrhagic retinopathy. Considering that in order to provide maximal benefit, fibrinolytic therapy should be administered as soon as possible after diagnosis of AMI, a full medical history and detailed medical examination including fundoscopy is often impossible.
The medical rationale for contraindication in these patients was based on a theoretically increased risk of retinal bleeding due to proliferative diabetic retinopathy, rather than on evidence from clinical trial or post-marketing findings. In this respect, the CPMP has recently undertaken a comprehensive review of published data and pharmacovigilance databases and found that the number of spontaneous and clinical trial reports of retinal haemorrhage following i.v. administration of fibrinolytic agents for the treatment of AMI is extremely small. On the other hand there is clear evidence of reduced cardiac morbidity and mortality and of a reduction in total mortality following the use of fibrinolytics in patients with AMI.
On the basis of all the data available, the CPMP concluded that the risk of intraocular haemorrhage is therefore outweighed by the increased chance of survival and reduced cardiac morbidity for the diabetic patient treated early with fibrinolytic therapy. The CPMP recommends the removal of the contraindications and warnings for use of iv fibrinolytics in diabetic patients or those with diabetic retinopathy.
Reference: CPMP Position Statement. The use of fibrinolytics in diabetic patients. 20 February 2003 EMEAI CPMP/82/03/en/Final