FDA: SSRI Use in Pregnancy (Potential Risk to Newborn)

[Retired]

Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn
Drugs.com
December 14, 2011

Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)

ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, 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 has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. FDA will update the SSRI drug labels to reflect the new data and the conflicting results.

BACKGROUND: SSRIs are marketed under various brand and generic drug names, and are used to treat depression and other psychiatric disorders. There are no adequate and well-controlled studies of SSRIs in pregnant women.

PPHN occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.

RECOMMENDATION: FDA advises health care professionals not to alter their current clinical practice of treating depression during pregnancy. See the Data Summary in the FDA Drug Safety Communication for additional information.

Source: FDA Drug Safety Communication

 

[David Baxter PhD]

FDA: Appropriate SSRI Use OK in Pregnancy

FDA: Appropriate SSRI Use OK in Pregnancy
By MICHELE G. SULLIVAN, Clinical Psychiatry News
December 15, 2011

Pregnant women taking selective serotonin reuptake inhibitors for depression may continue to do so, despite a 2006 warning that the drugs may predispose infants to persistent pulmonary hypertension, the Food and Drug Administration announced Dec. 14.

That earlier warning was based on a single study indicating that infants exposed to the drug in utero after the 20th week of pregnancy were six times more likely to develop persistent pulmonary hypertension (PPHN) than nonexposed infants (N. Engl. J. Med. 2006;354:579-87).

"Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause persistent pulmonary hypertension," the FDA said in a press statement.

The agency will update the drugs’ warning labels to reflect data from new studies, which have produced conflicting results about the risk SSRIs may pose to an unborn child.

Those studies include a large retrospective database study in 2009 that found no association between SSRI use and PPHN (Pharmacoepidemiol. Drug Saf. 2009;18:246-52), and a 2011 case-control study of 11,923 births that showed PPHN was associated with cesarean delivery but not with SSRI use in the second half of pregnancy (Am. J. Perinatol. 2011;28:19-24).

FDA officials concluded that the evidence is not sufficient to withhold SSRI treatment from pregnant women or take them off the antidepressants. "At present, FDA ... recommends that health care providers treat depression during pregnancy as clinically appropriate," according to the agency’s statement.

Physicians and their patients should carefully weigh the risks and benefits of any antidepressant use in pregnancy, the FDA added, given that there are "substantial risks associated with undertreatment or no treatment of depression during pregnancy."

Risks of untreated maternal depression can include low birth weight, preterm delivery, lower Apgar scores, poor prenatal care, failure to recognize or report impending labor, and increased risks of fetal abuse, neonaticide, or maternal suicide, the FDA warned.

Both the American Psychiatric Association and the American College of Obstetricians and Gynecologists recommend monitoring pregnant women for depression and treating them appropriately.

Physicians should continue to report any possible adverse effects to the FDA’s MedWatch program. Reporting forms can also be requested by calling 800-332-1088. The form can be submitted online or by fax to 800-FDA-0178.

 

[David Baxter PhD]

Link Between SSRIs and Rare Newborn Condition Still Unclear

Link Between SSRIs and Rare Newborn Condition Still Unclear
Yael Waknine, Medscape
December 14, 2011

The link between the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and persistent pulmonary hypertension of the newborn (PPHN) remains unclear, says the US Food and Drug Administration (FDA).

In a drug and safety communication released December 14, the agency says it is uncertain whether SSRIs cause PPHN because the data are conflicting.

"Two studies suggest an increased risk for PPHN with SSRI use in pregnancy. Three other studies do not support this association and the potential risk with SSRI use during pregnancy remains unknown," the FDA release notes.

As a result, the agency recommends that pregnant women who are taking antidepressants do not stop treatment.

The update follows an FDA advisory released in July 2006 and reported by Medscape Medical News at that time regarding the potential risk for PPHN associated with gestational exposure to SSRIs.

On the basis of a single study, those data suggested that the continued use of antidepressants past the 20th week of pregnancy was linked to a 6-fold increase in the risk for PPHN, and that discontinuance of antidepressants was associated with a 5-fold increased risk for depression relapse.

At that time, the FDA noted that the potential risk added to growing concerns regarding SSRI safety in pregnancy but that the risk had not been confirmed by other studies.

"Since then, 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 officials noted in the news release, adding that any conclusions regarding the potential connection are premature.

Clinicians are advised to weigh the small potential risk for PPHN against the substantial risks associated with untreated pregnancy during depression, which may lead to poor outcomes, such as low birth weight, preterm delivery, lower Apgar scores, poor prenatal care, failure to recognize and report signs of labor, and an increased risk for fetal abuse, neonaticide, or maternal suicide.

PPHN, which typically occurs in 1 or 2 per 1,000 births, often involves severe respiratory failure that requires intensive ventilator support to increase oxygen levels. Severe cases can result in multiple organ damage, including brain damage, and even death.

Healthcare professionals are encouraged to report SSRI-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.