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  1. Ron Batagol
    15/08/2016

    Having been involved in the safety of medicines in obstetrics area of providing assessment of risk versus benefit information for health professionals and more recently also in plain English format for patients, the comments of Karalyn about needing to thinking outside of the square, are certainly very relevant.:
    Just recently, I wrote in AJP Forum (14/6/16) about such an issue concerning the now very widely-used TNF Inhibitors, frequently, of course, as an option for treating a range of rheumatoid conditions.

    To briefly summarise:

    We know that TNF Inhibitors consist of an Fc component and an anti-TNF fragment (Fc is a component of igG1).

    Therefore, although these large molecules don’t cross the placenta by passive diffusion in early pregnancy, and are therefore not regarded as teratogenic, later in pregnancy, near the end of the 2nd. trimester, they may bind to the Fc receptor which the placenta produces to facilitate the transfer of IgG to the fetus to confer infant immunity , since, as noted, they (anti-TNFs) contain an FC component in their structure and:

    1. Get transferred across the placenta late in pregnancy and

    2. This binding to Fc prolongs the half-life of TNF inhibitors so there may be a reduced immunity in the newborn infant. Also –TNF inhibitors may be detectable in the infant’s system up to 6 months after birth.

    (Generally, If TNF inhibitors are used beyond the end of the 2nd trimester, the general advice is to avoid live vaccines in the infant for the first 6 months).

    However, when used during breastfeeding, the consensus of expert opinion is that these large molecules, which are not absorbed, and, indeed any residues which are present in breast milk would be destroyed in the infant G-I tract, may be safely given, so pharmacists and other health professionals should not be dissuaded by cautionary product information and the like- just look at what Lactmed and AMH and Thomas Hales have to say!
    Lactmed says as follows:
    Limited information indicates that maternal adalimumab injections produce low levels in milk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular
    weight of about 148,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Most experts feel that the drug is probably safe during nursing.

    Lactmed is a very reliable and easy to access resource on the safety of medicines in breastfeeding.

    Also, pharmacists should utilise the excellent obstetric information centres in the various States and Territories. The link to these, which is provided in TGAs Prescribing Medicines in Pregnancy database is:

    https://www.tga.gov.au/obstetric-drug-information-services

    Ron Batagol,
    Pharmacist and Obstetric Drug Information Consultant,
    Nunawading Vic 3131

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