who warned about antidepressants in pregnancy, and what they said next
picture a woman on an antidepressant who has just found out she is pregnant, searching at midnight. what she finds is a pile of headlines about warnings. what she does not find is the order they came in, the numbers inside them, or the part where the same agency that warned came back five years later and said the evidence was conflicting. this page is the notices themselves, in order, from the regulators’ own pages, with the sentence every one of them ends on.
the notices, in order
six notices from two regulators, each read on the agency’s own page or its archived copy. the fourth row is the one the headlines never carry: the agency that warned in 2006 came back in 2011 and said the evidence was conflicting.
| when | who | what it said | the number inside it | how it ended |
|---|---|---|---|---|
| 8 December 2005 | US FDA[1] | Public Health Advisory on paroxetine: an epidemiology study suggested first-trimester exposure may be associated with cardiac birth defects; the label was changed. | no figure quoted in the notice we read; the 2005 advisory is cited by the 2006 one | its own text was not read today; it is known here through the 2006 advisory that cites it |
| 19 July 2006 | US FDA[1] | Public Health Advisory on all SSRIs and persistent pulmonary hypertension of the newborn (PPHN), based on one study; all SSRI labels to carry it. | PPHN “six times more common” after SSRI use past the 20th week; background about 1 to 2 per 1,000 births; study “too small to compare” drugs | “should not stop any antidepressant without first consulting their physician” |
| May 2010 | UK MHRA[3] | Drug Safety Update: SSRIs and SNRIs and PPHN, with the absolute numbers. | about 5 per 1,000 with late-pregnancy use vs 1 to 2 background: 3 to 4 extra cases per 1,000 | ask about use in late pregnancy; watch exposed newborns |
| 14 December 2011 | US FDA[2] | Drug Safety Communication: new studies conflict; the 2006 warning is not confirmed. | “unclear whether use of SSRIs during pregnancy can cause PPHN” | “not to alter their current clinical practice of treating depression during pregnancy” |
| 2014 | UK MHRA[4] | Drug Safety Update: fluoxetine and a possible small risk of congenital cardiac defects. | described in the title as a possible small risk; the notice body was not read today | no wording claimed |
| 7 January 2021 | UK MHRA[5] | Drug Safety Update: SSRIs and SNRIs in the month before delivery and postpartum haemorrhage. | risk increased “by less than two-fold” | consider “the risks of untreated depression in pregnancy” |
what the sequence says
the 2006 warning rested on one study and said so.[1] the 2010 uk notice turned “six times” into a count a person can hold: about five in a thousand instead of one or two, so three or four extra newborns per thousand late-pregnancy exposures.[3] by 2011 the fda had newer studies that pointed different ways, said it could not conclude the drugs cause the condition, and told doctors not to change how they treat depression in pregnancy.[2] the 2021 uk notice on bleeding after delivery put its own risk at less than double and, in the same paragraph, told clinicians to weigh the risk of untreated depression.[5] a warning, a number, a partial retraction, and a smaller warning with the other direction built in. that is the record. a headline that carries only the first row has picked a side.
the other direction
untreated depression in pregnancy carries its own measured risks, and the regulators say so inside the warnings. we keep that side on its own page, with the numbers and their caveats.[7] read the two together; neither is complete alone.
agencies we could not read today
these were asked for. their pages either refuse automated reading or render nothing without a browser, so nothing is claimed for them. they are listed so that “not shown” is never mistaken for “nothing there.”
| agency | status |
|---|---|
| European Medicines Agency | class labelling on PPHN and the paroxetine cardiac wording are in EU product information; the EMA site refused automated reading today, so no date or wording is claimed here. |
| Sweden, Norway, Denmark, Finland | the Nordic agencies’ pages are script-only from here. The honest sentence is that the Nordic countries are where much of the evidence came from (national birth and prescription registers), not where distinctive warnings were issued; that sentence is itself unverified today and appears only in this table. |
| Switzerland (Swissmedic) and Israel (Ministry of Health) | could not be read today. We know of no distinctive national warning from either, which is “unknown,” not “none.” |
| Health Canada, Australia (TGA) | Health Canada’s current alert search returned no SSRI-pregnancy notice; older advisories may sit in an archive we did not reach. The TGA site did not answer. |
| US FDA, 2025 | an FDA expert panel on SSRIs in pregnancy was convened in 2025; we did not read its record today and make no claim about it. |
questions people ask
Which countries have warned about SSRIs in pregnancy?
The two regulators whose notices we read on their own pages are the US FDA (2005 paroxetine, 2006 all SSRIs and newborn lung pressure, then a 2011 update saying the evidence conflicted and advising doctors not to change practice) and the UK MHRA (2010 newborn lung pressure with the absolute numbers, 2014 fluoxetine, 2021 postpartum bleeding). EU product information carries class wording. The Nordic countries, Switzerland and Israel are listed on this page as not verified today, not as absent.
Did the FDA withdraw its SSRI pregnancy warning?
It softened it. In July 2006 the FDA said newborn lung pressure was six times more common after SSRI use late in pregnancy, on the strength of one study. In December 2011 it said new studies conflicted, that it did not find sufficient evidence to conclude SSRIs cause the condition, and that doctors should not alter how they treat depression in pregnancy. The label language stayed, updated to reflect the conflict.
How big is the newborn lung risk in numbers?
The UK regulator put it at about five cases per 1,000 pregnancies with late-pregnancy SSRI use, against a background of one to two, so three to four extra cases per thousand. That is the number the 2006 “six times” headline turns into once you know the baseline.
Should I stop my antidepressant because I am pregnant?
Every notice on this page ends with the same instruction, and so does this page: not on your own. The 2006 FDA advisory says women should not stop any antidepressant without first consulting their physician; the 2021 UK notice tells clinicians to weigh the risks of untreated depression in pregnancy. The decision is a conversation with your prescriber, with this page in your hand.
sources
- US Food and Drug Administration. Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns. 19 July 2006. Archived copy (the live FDA page has moved). States that PPHN was “six times more common in babies whose mothers took an SSRI antidepressant after the 20th week,” that the study was “too small to compare the risk in one drug compared to another,” that FDA asked all SSRI sponsors to add PPHN to prescribing information, and refers to the FDA Public Health Advisory for Paxil dated December 8, 2005 on first-trimester cardiac birth defects. Verbatim: “Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician.” https://web.archive.org/web/2012/https://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm124348.htm
- US Food and Drug Administration. Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies. 14 December 2011. Archived copy. Verbatim: “there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN”; “FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy”; “FDA does not find sufficient evidence to conclude that SSRI use in pregnancy causes PPHN, and therefore recommends that health care providers treat depression during pregnancy as clinically appropriate.” https://web.archive.org/web/2016/https://www.fda.gov/Drugs/DrugSafety/ucm283375.htm
- UK Medicines and Healthcare products Regulatory Agency. Drug Safety Update, May 2010 (republished on gov.uk 11 December 2014): SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn. Background rate one to two cases per 1,000 pregnancies; with SSRI use in late pregnancy approximately five per 1,000; an extra three to four cases per 1,000. Advice: ask about use in later pregnancy; observe exposed newborns. https://www.gov.uk/drug-safety-update/ssris-and-snris-risk-of-persistent-pulmonary-hypertension-in-the-newborn
- UK Medicines and Healthcare products Regulatory Agency. Drug Safety Update (republished 11 December 2014): Fluoxetine: possible small risk of congenital cardiac defects. https://www.gov.uk/drug-safety-update/fluoxetine-possible-small-risk-of-congenital-cardiac-defects
- UK Medicines and Healthcare products Regulatory Agency. Drug Safety Update, 7 January 2021: SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery. Verbatim: use in the month before delivery “increases the risk by less than two-fold”; healthcare professionals should “continue to consider the benefits and risks for use of antidepressants during pregnancy, and the risks of untreated depression in pregnancy.” https://www.gov.uk/drug-safety-update/ssri-slash-snri-antidepressant-medicines-small-increased-risk-of-postpartum-haemorrhage-when-used-in-the-month-before-delivery
- UK Medicines and Healthcare products Regulatory Agency. SSRIs and SNRIs: use and safety. Overview page, 18 December 2014. https://www.gov.uk/government/publications/ssris-and-snris-use-and-safety
- Untreated depression in pregnancy, both directions, with the numbers: veisund.com/topics/depression-and-anxiety-in-pregnancy. https://www.veisund.com/topics/depression-and-anxiety-in-pregnancy
related: depression and anxiety in pregnancy · paroxetine: the legal record
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