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The Canadian equivalent of the Food and Drug Administration (FDA), Health Canada, issued a public advisory on August 9, 2004 warning that newborns may be adversely affected when their mothers take one of the family of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) and other newer anti-depressants during the third trimester of pregnancy.
The advisory applies to the following anti-depressants:
- bupropion (WELLBUTRIN; the warning also applies to ZYBAN when used...
The Canadian equivalent of the Food and Drug Administration (FDA), Health Canada, issued a public advisory on August 9, 2004 warning that newborns may be adversely affected when their mothers take one of the family of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) and other newer anti-depressants during the third trimester of pregnancy.
The advisory applies to the following anti-depressants:
- bupropion (WELLBUTRIN; the warning also applies to ZYBAN when used for smoking cessation) citalopram (CELEXA)
- fluoxetine (PROZAC)
- fluvoxamine (LUVOX)
- mirtazapine (REMERON)
- paroxetine (PAXIL)
- sertraline (ZOLOFT)
- venlafaxine (EFFEXOR)
Health Canada reported that some newborns whose mothers took these drugs during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support, and tube feeding. The symptoms reported include: feeding and breathing difficulties or both, 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 antidepressant on the baby, or possibly a withdrawal syndrome caused by sudden withdrawal from the mother’s blood levels of the drug after birth. A withdrawal syndrome is well recognized with all SSRI antidepressants in adults. The symptoms generally start within one to three days after stopping the drug, and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are: dizziness, vertigo, uncoordination, nausea and vomiting, and flu-like symptoms that include fatigue, lethargy, muscle pain and chills. DO NOT stop taking any of these drugs without medical supervision.
What is the FDA doing to address this issue? On June 10, 2004, two months before the Canadian warning was issued, the agency held an advisory committee meeting of outside experts to review the adverse effects seen in newborns whose mothers were taking these drugs during the third trimester.
The committee agreed with the need to change the professional product labeling, or package insert, to reflect the concern about newborns. A drug’s professional labeling is written for pharmacists and physicians and is not routinely distributed to patients at the time a drug is dispensed at the pharmacy. Therefore, patients usually do not know when new safety warnings are required on a drug’s professional labeling.
In a move that we find astoundingly paternalistic, the committee recommended against the issuance of an FDA public health advisory, as the Canadians did, for fear that it would unduly scare mothers from taking their antidepressants.
The committee supported physician education as a means of communicating the potential risks to newborns from the drugs. At the same time, the committee recommended against issuance of a “Dear Healthcare Professional” letter informing health professionals of the potential problem due to the “intricacies of the risk/benefit considerations.” We are unsure what the last part of this recommendation means.
The one committee recommendation we strongly support is the mandatory distribution by pharmacists of FDA-approved information written specifically for patients in non-technical language about the risks for the newborn and for the mother when choices must be made about the use of these drugs in pregnancy.
Warnings about the clinical worsening of depression and increased suicide risk when antidepressant treatment is started or when doses are changed are now required in the FDA-approved professional product labeling for a number of antidepressants (see Worst Pills, Best Pills News August 2004).
What You Can Do
If you are pregnant and must take one of the antidepressants listed in this article, be sure to inform the physician delivering the baby that you are on an antidepressant.
