New warnings Paxil + pregnancy:
There have been reports today in the media that some studies have found
increased birth defects attributable to Paxil use during the first trimester:
http://www.npr.org/templates/story/s...45096&ft=1&f=2
Quote:
Drugmaker GlaxoSmithKline has sent a warning letter to doctors, advising that the antidepressant Paxil may be linked to a slightly higher risk of birth defects in babies exposed to the drug during the first trimester of pregnancy. The company also has added the warning to its Paxil label. This comes on the heel of a new study requested by the Food and Drug Administration.
Glaxo described the findings as a surprise. Other studies had shown no increase in birth defects. In the latest study, the company looked at data from more than 3,500 pregnant women taking antidepressants. It found four percent of the women taking Paxil had babies born with birth defects, compared to two percent taking other antidepressants. For comparison, the rate of birth defects in the general population is about three percent. In this study, the most common birth defects with Paxil were heart problems.
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Here is the link to the warning letter: Notice it is dated Sept 2005
http://www.fda.gov/MedWatch/SAFETY/2...hcp_letter.pdf
Health Canada also has been involved. Here is a quote from Mar 06:
Quote:
Health Canada Issues Pregnancy Warning For Antidepressants
Newborns Whose Mothers Took SSRIs At Increased Risk Of Serious Lung Disorder
On March 10, 2006 Health Canada issued a warning for women taking antidepressant drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs) -- including Prozac and Paxil -- and who are pregnant or thinking of becoming pregnant.
Health Canada issued this advisory to draw attention to a recent study published in The New England Journal of Medicine which linked Prozac, Paxil, and other drugs in the SSRI class to a rare but potentially fatal condition in newborns called persistent pulmonary hypertension. According to the advisory, cases of persistent pulmonary hypertension have been reported in babies born to women who took SSRI antidepressants during the second half of their pregnancies.
Health Canada urged women using antidepressants in the SSRI class and who are pregnant or intend to become pregnant to immediately discuss the situation with their doctor due to the seriousness of this side effect risk to the baby. Specifically, the March 2006 advisory provided this information about the persistent pulmonary hypertension side effect:
“Newborns with this rare but life-threatening condition [persistent pulmonary hypertension] do not receive enough oxygen in the blood and require intensive-care treatment to survive."
“According to the study, babies born with [persistent pulmonary hypertension] were six times more likely than healthy babies to have been exposed to SSRIs. This information is considered to be preliminary at this time.”
The following antidepressant drugs in the SSRI class were mentioned in this Health Canada advisory:
* Wellbutrin (bupropion);
* Celexa (citalopram);
* Cipralex (escitalopram);
* Prozac (fluoxetine);
* Luvox (fluvoxamine);
* Remeron (mirtazapine);
* Paxil (paroxetine);
* Effexor (venlafaxine); and,
* Zoloft (sertraline).
This pregnancy warning from Health Canada included, also, Zyban (bupropion), a medication prescribed for smoking cessation.
Health Canada has emphasized that women should not stop taking their antidepressant SSRI drug before first consulting with their doctor. In providing some guidance to doctors, the Health Canada advised that a pregnant woman's use of SSRI drugs should only be continued where the doctor believes the benefits to the patient outweigh the risks to the fetus.
Lastly, the March 2006 advisory reminded women and their doctors that an increased risk of major birth defects has also been associated with the use of Paxil and other SSRI drugs.
(Posted by: Tom Lamb)
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from http://www.drug-injury.com/druginjur...ion/index.html
So the bottom line? Women who must take antidepressants, must consult with their doctors, and discuss this (benefits vs risk). There are fetal heart ultrasounds which may be useful in detecting damage. |
