Other safety alerts
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| European Union: Advice to postpone use of live vaccines in infants exposed to infliximab during pregnancy or via breastfeeding |
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The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) informs healthcare professionals on the need to postpone the use of live vaccines in infants who are exposed to infliximab during pregnancy or via breastfeeding.
Infliximab is an anti-inflammatory medicine authorised for the treatment of adults with rheumatoid arthritis (an immune system disease causing inflammation of the joints), Crohn’s disease (a disease causing inflammation of the digestive tract), ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut), ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) or psoriasis (a disease causing red, scaly patches on the skin). Infliximab is also authorised in patients aged between 6 and 17 years with severe, active Crohn’s disease or severely active ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Following treatment during pregnancy, it has been reported that infliximab crosses the placenta and it has been detected in infants up to 12 months after birth. Live vaccines should not be given to infants for 12 months after birth if they have been exposed to infliximab during pregnancy. If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier time point if there is a clear clinical benefit for the individual infant.
Infliximab has also been detected at low levels in breast milk, therefore, administration of a live vaccine to a breastfed infant while the mother is receiving the medicine is not recommended unless infant infliximab serum levels are undetectable.
It is important that women treated with infliximab who become pregnant or who breastfeed their infant inform the healthcare professional responsible for vaccination of their infant about their treatment with infliximab.
The DHPC for infliximab will be forwarded to EMA’s human medicines committee, the CHMP.
Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holders according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in the EU Member States.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-february-2022
In Hong Kong, there are 3 registered pharmaceutical products containing infliximab. So far, the Department of Health (DH) has received 15 cases of adverse drug reaction related to infliximab, but these cases are not related to use of live vaccines in infants exposed to infliximab during pregnancy or via breastfeeding. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Feb 12, 2022
Issued at HKT 12:00
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