Safety of rapid-acting insulin analogues in pregnant women with diabetes in view of approved prescribing information

Abstract

Diabetes accompanying pregnancy exposes both the mother and the foetus to a number of risks. Good glycaemic control during pregnancy is a key factor to reduce those risks and, therefore, glycaemic goals in this condition are very restrictive. In Poland, only insulin is recommended for the pharmacological treatment of diabetes during pregnancy. Due to the specific situation of pregnant women, when the safety of medicines affects both the mother and the foetus, clinical trials are subject to significant limitations and their results are evaluated with extreme caution. For many years, there have been discussions about the safety of rapid-acting insulin analogues and the possibility of their use during pregnancy. The current records of registration in Poland (summaries of product characteristics) indicate that insulin aspart, lispro and glulisine are registered in all types of diabetes, and they do not explicitly prohibit use of any of them in pregnant women. At the same time they inform about the various states of knowledge on the safety of each of the analogues in pregnancy. The safety of insulin aspart and lispro appears to be well substantiated, but lack of data from studies with insulin glulisine makes it not possible to assess its safety in pregnancy.