In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing ketorolac [for systemic use], reached the following conclusions.
Given the data available in the literature on anastomotic leakage, the PRAC considers that a causal relationship between the use of ketorolac [for systemic use] and anastomotic leakage is at least possible. The PRAC concluded that the instructions for medical use of medicinal products containing ketorolac [for systemic use] should be amended accordingly.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions, the CMDh considers that the benefit/risk balance of medicinal products containing ketorolac [for systemic use] remains unchanged, taking into account the proposed amendments to the instructions for medical use.
Amendments to be included in the relevant sections of the package inserts (new text underlined in bold, deleted text struck through).
Section “Special warnings and precautions for use”
The following warning should be added:
Subsection "Gastrointestinal disorders":
[…]
NSAIDs, including ketorolac, may be associated with an increased risk of gastrointestinal anastomotic leak. Careful medical supervision and caution are recommended when using ketorolac after gastrointestinal surgery.
[…]
List of medicinal products containing ketorolac [for systemic use] and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 13.06.2023)
To analyze the published information, the applicant must use the original text available at the link:
