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Got the flu injection today

  • 26-01-2011 8:21pm
    #1
    Registered Users, Registered Users 2 Posts: 2,170 ✭✭✭


    Just a heads up that while it is recommended for pregnant women there some evidence that it is not deemed totally safe in the first trimester Got it in Boots for €30.

    The literature I was given stated that they had not done sufficient testing on first trimester trials to rule out any risks.


Comments

  • Registered Users, Registered Users 2 Posts: 2,921 ✭✭✭silja


    Interesting... where I currently live (USA) they say the shot is safe, but the mist is not.


  • Registered Users, Registered Users 2 Posts: 2,170 ✭✭✭Grawns


    The mist is a live virus and the shot is not. Maybe there's different versions of the shot, the one I got is Fluarix. This is the fact sheet

    and here's the relevent quote

    8.1 Pregnancy
    Pregnancy Category B
    A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 56 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to FLUARIX. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLUARIX should be given to a pregnant woman only if clearly needed.In a reproductive and developmental toxicity study, the effect of FLUARIX on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered FLUARIX by intramuscular injection once prior to gestation, and during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 56-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed.


  • Registered Users, Registered Users 2 Posts: 1,501 ✭✭✭lonestargirl


    Grawns wrote: »
    Just a heads up that while it is recommended for pregnant women there some evidence that it is not deemed totally safe in the first trimester Got it in Boots for €30.

    The literature I was given stated that they had not done sufficient testing on first trimester trials to rule out any risks.

    Remember that 'no evidence of it not being safe' is not the same as 'evidence of it not being safe'.

    You have this issue with pretty much any drug, no ethics committee is ever going to ok a trial where the unborn child cannot consent (except for chemo etc. where there is a real risk to the life of the mother). Thus the only data we have is from observation, i.e. paracetamol is deemed safe as people have been taking it for years, equally in the US (where bith Silja and I are) they are more pro-active with vaccination and many 1st trimester women have had it.

    The same issue arises with children's medication, mostly they say 'not for under 2s' not because they have found it dangerous but because it too costly to test. Of course people then go and prescribe it 'off-label' removing any responsibility from the drug company. The FDA now give extended patents to companies who test their drugs on children in order to incentivise them to do so.


  • Registered Users, Registered Users 2 Posts: 2,170 ✭✭✭Grawns


    This is just a heads up for those TTC as we're busy taking our folic acid not a discussion on medical testing and the pro's and cons of vaccinations.


  • Registered Users, Registered Users 2 Posts: 1,501 ✭✭✭lonestargirl


    Grawns wrote: »
    This is just a heads up for those TTC as we're busy taking our folic acid not a discussion on medical testing and the pro's and cons of vaccinations.
    I'm not talking about the pros and cons either I'm just explaining how there never will be any proof of it being safe except from retrospective analysis of those who have taken it as no company would ever test it in this situation.
    Grawns wrote: »
    some evidence that it is not deemed totally safe in the first trimester.
    As I said lack of evidence of safety is not equivalent to evidence that it is not safe.


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