Based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing betamethasone, the Pharmacovigilance Risk Assessment Committee (PRAC) drew the following conclusions.
In view of literature data on cases of pheochromocytoma crisis closely associated in time with the use of medicinal products containing betamethasone, including two with a positive re-challenge test, PRAC concluded that the package inserts of medicinal products containing betamethasone should be amended accordingly.
In view of the literature data indicating an increased risk of neonatal hypoglycemia after antenatal use of medicinal products containing betamethasone, PRAC concluded that appropriate amendments should be made to the instructions for medical use.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the PRAC scientific conclusions.
The CMDh considers that the benefit/risk balance of medicinal products containing betamethasone remains unchanged, taking into account the proposed changes to the instructions for medical use.
Amendments to be included in the relevant sections of the package insert (new text underlined in bold, deleted text struck through).
For systemic (oral and parenteral) medicinal products
“Special precautions for use” section
Cases of pheochromocytoma crisis, including fatal ones, have been reported. In patients with identified pheochromocytoma or suspected pheochromocytoma, corticosteroids should be prescribed only after an appropriate assessment of the benefit-risk balance.
For parenteral medicinal products
Section “Use during pregnancy or breastfeeding”
Studies have shown an increased risk of neonatal hypoglycemia after a short antenatal course of betamethasone (betamethasone) in women at risk of late preterm birth.
List of medicinal products containing betamethasone (betamethasone) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products of Ukraine as of 05.11.2021). (11 KB) (Downloaded: 12.11.2021 06:51:16)
To analyze the published information, the applicant must use the original text available at the linkhttps://www.ema.europa.eu/en/documents/psusa/betamethasone-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00000391/202101_en.pdf
