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Thread: AntiDepressants Warning in Pregnancy-Health Canada

  1. #1
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    Default AntiDepressants Warning in Pregnancy-Health Canada

    Advisory
    2006-11
    March 10, 2006
    For immediate release Source: Health Canada


    Newer antidepressants linked to serious lung disorder in newborns

    OTTAWA - Health Canada is advising women who are taking antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRI) and who are pregnant or intend to become pregnant to discuss the situation with their doctor due to potential risks to the baby.

    Health Canada stresses that patients should not stop taking SSRI medication without first consulting their doctors, as they could experience serious side effects.

    Generally, SSRI treatment should only be continued if the benefits to the individual patient are thought to outweigh the risks to the unborn child, while also considering the benefits and risks of switching to another treatment option or stopping treatment altogether. These precautions and the possibility of adverse health effects in newborns are mentioned in the current Canadian prescribing information and consumer information for SSRIs.

    SSRIs and other newer antidepressants prescribed for the treatment of depression include the following drugs: Wellbutrin (bupropion), Celexa (citalopram), Cipralex (escitalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Remeron (mirtazapine), Paxil (paroxetine), Zoloft (sertraline) and Effexor (venlafaxine), and Zyban (bupropion) for smoking cessation.

    A study published recently in the New England Journal of Medicine suggests that use of SSRIs during the second half of pregnancy may be associated with a condition called persistent pulmonary hypertension of the newborn. Newborns with this rare but life-threatening condition do not receive enough oxygen in the blood and require intensive-care treatment to survive. According to the study, babies born with this condition were six times more likely than healthy babies to have been exposed to SSRIs. This information is considered to be preliminary at this time.

    Numerous reports in Canada and abroad have already indicated that some children exposed to SSRIs and other newer antidepressants during pregnancy may develop serious complications at birth. An increase in the overall risk of major birth defects has also been associated with SSRI use.

    The safety of these drugs is vigilantly monitored and Canadians will continue to be informed if new concerns arise. Health Canada advisories on other SSRI-related complications in newborns are available on the Health Canada website (see August 9, 2004, October 6, 2005 and December 22, 2005).

    Managing the adverse reactions of marketed health products depends on the active participation of both healthcare professionals and consumers in reporting these reactions. The spontaneous reporting of adverse reactions generally underestimates the risks associated with the use of marketed health products.

    To report a suspected adverse reaction to SSRIs or other newer antidepressants, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

    Telephone: 866-234-2345
    Facsimile: 866-678-6789

    CADRMP
    Marketed Health Products Directorate
    Health Protection Building, Tunney?s Pasture, AL 0701C

    Email: cadrmp@hc-sc.gc.ca

    Consumers requiring more information about this advisory can contact the Health Canada public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

  2. #2

    Default Re: AntiDepressants Warning in Pregnancy-Health Canada

    I am trying to find an updated (extremely recent) study on Prozac. I have been told there is a new one just completed that is on the verge of being made public.

    If anyone knows where I can obtain this information I would be most appreciative.

  3. #3
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    Default Re: AntiDepressants Warning in Pregnancy-Health Canada

    Patti,

    Can you provide a few more details on the information you have to assist in finding some info.

    In what Country is the study being done?

    Who is performing the study...is it the manufacturer or an independent group? Name of the lead investigator of the institution.

    What is the goal of the study?

    In the meantime I'll see what I can dig up.

  4. #4
    Join Date
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    Default Re: AntiDepressants Warning in Pregnancy-Health Canada

    Patti,

    Please have a look at This New Forum Posting to see if your questions are addressed

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