CCFA PREGNANCY PAMPHLET UPDATE: REMICADE AND BREAST MILK

Monday, July 17, 2006

Alerted to the error in their information, the CCFA pregnancy information on Remicade has been changed from:

"It also does not appear in breast milk." [bold added]

to the more correct:

"It has not been found in breast milk, nor does it damage sperm." [bold faced added]

The change is subtle. If read quickly, it seems that Remicade is not passed through breast milk. However, the truth is that no studies have been done and, as the National Institute of Health says:

"It is not known whether infliximab passes into breast milk."

source: http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/203667.html#SXX24

While the CCFA spins the information on the side of "it seems safe", the European Union prefers caution:

"It is not known if infliximab [Remicade] is excreted in human milk. If you are a nursing mother, your doctor will advise you to stop nursing after Remicade treatment."

source: www.emea.eu.int/pdfs/human/press/pus/003202.pdf

The EU is taking its lead from Centocor, the manufacturer of Remicade. Centocor also warns against breast feeding and pregnancy:

"The available clinical experience is too limited to exclude a risk, and administration of infliximab is therefore not recommended during pregnancy.

Women of childbearing potential
Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.

Lactation
It is not known whether infliximab is excreted in human milk or absorbed systemically after ingestion. Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment."

source: www.centocor.nl/Download.aspx?file=/Uploads/Producten/RemicadeEN.pdf

Note that these warnings are from Centocor's Netherlands site . . . why the disparity between US and European warnings for the same drug?