Newborns - SSRI's

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2004-44

August 9, 2004

For immediate release

http://www.hc-sc.gc.ca/english/protection/warnings/2004/2004_44.htm

 

Advisory

 

" Health Canada advises of potential adverse effects

of SSRIs and other anti-depressants on newborns "

 

 

OTTAWA - Health Canada is advising Canadians that newborns may be

adversely affected when pregnant women take Selective Serotonin Re-uptake

Inhibitors (SSRIs) and other newer anti-depressants during the third

trimester of pregnancy. This advisory is intended to increase awareness

among mothers and physicians of the possible symptoms that may occur in

the newborn, so that symptoms can be recognized and addressed quickly.

 

This advisory applies to the following anti-depressants: bupropion

(whether used for depression or for smoking cessation), citalopram,

fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline and

venlafaxine.

 

International and Canadian reports reveal that some newborns whose

mothers took these medications during pregnancy have developed

complications at birth requiring prolonged hospitalization, breathing

support and tube feeding. Reported symptoms include: feeding and/or

breathing difficulties, seizures, muscle rigidity, jitteriness and

constant crying. In most cases, the newer anti-depressant was taken

during the third trimester of pregnancy. These symptoms are consistent

with either a direct adverse effect of the anti-depressant on the baby,

or possibly a discontinuation syndrome caused by sudden withdrawal from

the drug.

 

When treating depression in pregnant women, physicians and patients

should carefully consider the potential risks and benefits of the various

treatment options for both the mother and the unborn baby. To date, there

is little evidence-based information on how best to treat depression

during pregnancy.

 

If a woman is pregnant and is taking an SSRI, or other newer

anti-depressant, she should discuss with the risks and benefits of the

various treatment options with her health care professional. It is very

important that patients do NOT stop taking these medications without

first consulting with their doctor.

 

The frequency of symptoms may vary with each drug. In the case of two of

the newer anti-depressants - bupropion and mirtazapine - discontinuation

problems appear to be less than with the other drugs. In the case of

mirtazapine, there are only two reports. Health Canada is issuing this

advisory to encompass all newer anti-depressants in order to alert

Canadians to the potential risk. Health Canada has also worked with the

manufacturers of these medications to update their labelling with new

precaution information.

 

Any suspected adverse reactions can be reported directly to the product

manufacturer or to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Marketed

Health Products Directorate

 

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

 

To report an Adverse Reaction, consumers and health professionals may

call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

 

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines

can be found on the Health Canada web site or in The Canadian Compendium

of Pharmaceuticals and Specialties.

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

 

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