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CCFA Pamphlet Error: Pregnancy, IBD, Remicade

July 10, 2006

The recent CCFA information on IBD and pregnancy fails to provide caution and contains a potentially dangerous factual error regarding Remicade and breast milk.

From the CCFA pamphlet on pregnancy:

"Infliximab (Remicade), a biologic compound approved for the treatment of both Crohn's disease and ulcerative colitis, [1] does not seem to be associated with increased risks to the developing fetus or with an increase in pregnancy complications. It also [2] does not appear in breast milk." [boldface added]

(1) Remicade and pregnancy: Failing to provide caution

Although the CCFA says Remicade "does not seem to be associated with increased risks to the developing fetus", according to the Remicade full prescribing information (pdf), no animal reproduction studies have been conducted with this drug. In addition:

"It is not known whether REMICADE can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. REMICADE should be given to a pregnant woman only if clearly needed." [boldface added]

The New Zealand Ministry of Health takes this a step further by advising:

"You should take adequate contraceptive measures to avoid pregnancy during treatment and for at least 6 months after the last infusion of REMICADE." [boldface added]

(2) Remicade and breast milk: Factual error

Regarding the CCFA statement that [2] Remicade does not appear in breast milk, this is incorrect. Remicade's "full prescribing information" page (downloadable PDF) for physicians reads:

"It is not known whether REMICADE is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from REMICADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother." [this may also be read on]

Somehow the CCFA jumped from "It is not known" whether Remicade is passed in breast milk to Remicade "does not appear in breast milk". This is despite knowledge that similar substances ("immunoglobulins") are indeed excreted in human milk. In addition, New Zealand's Ministry of Health gives the the following warnings regarding Remicade and breastfeeding:

"If you are breastfeeding, your doctor will advise you to discontinue breastfeeding for at least 6 months after treatment with REMICADE." [boldface added]

To sum it up, if you take Remicade and are considering having a baby, there is no evidence that the drug is safe for pregnancy or breastfeeding. Indeed, available evidence indicates that the drug is probably harmful! Do your research!

(disclaimer: Posts which criticize the CCFA are written in the interest of safety. It's hard for the CCFA to criticize the companies which provide their funding. BTW, I did receive a Certificate of Appreciation from the CCFA in 2004:)