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355 Tysabri Pregnancies were similar to the general population

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    355 Tysabri Pregnancies were similar to the general population

    Pregnancy and Natalizumab

    Friend S, Richman S, Bloomgren G, Cristiano LM, Wenten M.
    Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study.BMC Neurol. 2016 Aug 24;16(1):150. doi: 10.1186/s12883-016-0674-4.


    BACKGROUND: Patients with multiple sclerosis (MS) or Crohn's disease (CD) being treated with natalizumab (Tysabri®, Biogen) who are planning to become pregnant or discover they are pregnant after exposure to natalizumab are currently advised to balance the potential benefits and potential risks of exposure when considering treatment options. This study was undertaken to evaluate pregnancy outcomes of women with MS or CD who were exposed to natalizumab at any time within 3 months prior to conception or during pregnancy. A pregnancy registry was created to better understand the effect of natalizumab exposure on pregnancy outcomes.

    METHODS:The Tysabri Pregnancy Exposure Registry was a global, observational exposure registration and follow-up study. Evaluations included spontaneous abortions (<22 weeks gestational age), fetal losses (≥22 weeks gestational age), ectopic pregnancies, elective or therapeutic terminations, stillbirths, birth defects, and live births. Birth defects were reviewed and coded in accordance with the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of birth defects.

    RESULTS:A total of 369 patients with MS and 7 patients with CD were enrolled, of whom 355 patients (99.4 %; 349 MS and 6 CD) had known pregnancy outcomes (including 8 twin sets). The spontaneous abortion rate was 9.0 % (n = 32; 95 % confidence interval [C. I.], 6.3-12.5 %). An independent advisory committee review determined the major birth defect rate to be 5.05 % (16 of 316 live births + 1 elective abortion; 95 % C. I., 2.9-8.1 %). The mean gestational age of the live-born infants was 38.3 weeks, and the mean birth weight was 3158.3 g.

    CONCLUSIONS: Although the overall rate of birth defects was higher than that observed by the MACDP, these registry outcomes showed no specific pattern of malformations that would suggest a drug effect, and the spontaneous abortion rate was consistent with that of the general population.


    My comments...This study presents strong evidence that women on Tysabri getting pregnant largely track the general population. Pregnancy warnings logically must be placed on drugs when they are too new to identify what the risk may be. But for FDA says pregnancy risk cannot be ruled out. Dear God! When the heck can it be for anyone taking any drug?!!!!! Or, not taking a drug for that matter!


    Based exclusively on the study above I encourage prospective mothers on Tysabri to seriously consider not switching meds if they are doing well with Tysabri. What is like to happen, IMO, is that MS can get worse on clearly less effective meds, you may become much less healthy to raise a child, and you will probably feel so crappy because of the sucky side effects of other meds it makes pregnancy even more difficult to achieve.

    JMHO, but most neuros, most thinking, is ***-backwards concerning Tysabri and pregnancy, if I can put it that way. Let's separate the BS from the science and make clear minded decisions regarding Tysabri and pregnancy. Nothing is more important than having healthy children being raised by moms who are in the best health possible.

    Best wishes, please know my heart and prayers are with each person struggling with these issues. Blessings to you!
    Last edited by Mamabug; 06-23-2018, 01:24 PM. Reason: Corrected spelling per request of OP
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