Paxil, Prozac Linked to Birth Defects in Study

Another study has linked antidepressants such as <"">Prozac and <"">Paxil to birth defects. This study, said Reuters, involves two antidepressants and a risk of birth defects based on a review of national data from Finland.

The research team discovered that woman taking Prozac (fluoxetine) and Paxil (paroxetine) experienced an increased risk of giving birth to babies with certain heart defects, said Reuters. Although the risks are small and the link has to be confirmed, study author Dr. Heli Malm told Reuters Health that the drugs in this class—selective serotonin reuptake inhibitors or SSRIs—”should only be used during pregnancy when clearly indicated.”

Reuters Health points out that while some data have revealed conflicting results, some studies have linked SSRIs with increased birth defect risks, including a Danish study that found the risk in mothers who took SSRIs such as Prozac, Zoloft (sertraline), and Celeza (citalopram). Reuters Health also discussed a 2010 study involving U.S. infants whose mothers used Wellbutrin (bupropion) in early pregnancy; the babies revealed a more than two-fold risk for specific heart defects known as left outflow tract defects.

This study looked at national data collected on 635,583 births from 1996 through 2006 and revealed that mothers taking Prozac (fluoxetine) in early pregnancy were likelier to give birth to babies with a specific type of birth defect, a ventricular septal defect which involves a hole between the heart’s left and right sides, said Reuters health. Also babies born to mothers taking Paxil (paroxetine) in early pregnancy were likelier to be born with defects of the heart’s right ventricular outflow tract; this affects blood flow from heart’s right chambers to body, Reuters Health explained.

An increased risk of neural tube defects was also seen in babies exposed to SSRIs as were increased risks related to disorders linked to alcohol. “The only explanation to this finding is that alcohol consumption is more abundant among women using SSRIs,” said Malm. “This may result from psychiatric problems,” quoted Reuters Health. The report appears in the journal Obstetrics & Gynecology

Earlier this year we reported that U.S. health regulators ordered cautions be added to ALL antipsychotic drug labels regarding their risk of abnormal muscle movements (extrapyramidal symptoms or EPS) and withdrawal syndromes in newborns when used in pregnancy. The new cautions will apply to older and new generation antipsychotics, including Haldol, FazaClo, Fanapt, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, Invega, Loxitane, Moban, Navane, Orap, Saphris, Stelazine, Thorazine, and Symbyax, according to an alert from the Food & Drug Administration (FDA).

The FDA identified 69 episodes of neonatal EPS or withdrawal in adverse event reports submitted to the agency through October 2008. Among the symptoms listed in the reports: Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. Onset of symptoms ranged from birth to one month later, and severity varied, as well. The FDA indicated that some infants recovered within hours while others needed intensive care and prolonged hospitalization.

As we’ve mentioned, the FDA recommends that healthcare professionals be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment.

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