OBJECTIVES

To evaluate the safety issues assessed under 107i referral in the EU and to identify the regulatory actions taken by the health authorities to prevent these safety issues.

METHODS

A thorough search was carried out on the EMA website from May 2013 to Jun 2019, to identify the safety issues associated with the group of medicines which were assessed under 107i referral and the regulatory actions taken by the health authorities to prevent these safety issues.

RESULTS

During the assessment period, 8 group of medicines were found to have prominent safety issues that required urgent regulatory action. Of these, the MA of 4 groups of medicines were revoked due to: heart rhythm problems (caused by fenspiride containing medicinal products), misuse of oral methadone formulations by injecting them into a vein (caused by methadone oral solution containing povidone), severe hypermagnesaemia (caused by Numeta G13% emulsion for infusion) and serious skin reactions including SJS, TEN and DRESS syndrome (caused by tetrazepam containing medicines). For other 4 groups of medicines, the MA was granted, however the use of aRMMs were recommended. The safety issues associated includes- kidney injury & death when used in critically ill patients and patients with sepsis (associated with HES containing medicinal products and HES solutions for infusion), liver problems including high liver-enzyme levels and liver failure (associated with flupirtine containing medicines) and thromboembolism (associated with cyproterone and ethinylestradiol containing medicines).

CONCLUSIONS

Safety of patients is always of prime importance for the health authorities who are giving approval to the medicines in the EU. For this purpose, 107i referral is followed for those medicines which require immediate regulatory action. During the study period, recommendation of aRMMs were given to majority of the medicine and complete revocation was followed only when the safety issues could not be managed by aRMMs.