Health News Update: Paxil and Pregnancy, Fluoride and Infant Formula

By Christine Cupaiuolo |

In other medical news, one year after the FDA identified concerns about the antidepressant Paxil and the increased risk of birth defects, ACOG is now recommending that women avoid Paxil if they are pregnant or planning on becoming pregnant. From HealthDay News (via Forbes):

ACOG’s Committee on Obstetric Practice “recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible,” read the statement, which is in the December issue of Obstetrics & Gynecology.

The guidelines come a full year after the U.S. Food and Drug Administration (FDA) issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy.

This warning was based on two studies. The first found about a 2 percent risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared with a 1 percent risk in the general population.

The second study found that the risk of heart defects was 1.5 percent in babies whose mothers took Paxil in the first three months of pregnancy, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester. The most common defects were cardiovascular.

ACOG’s statement also notes that “the potential risk of SSRIs during pregnancy must be weighed against the risk of depression relapse if the medication is discontinued. Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications.”

In December 2005, the FDA released a public health advisory stating that “exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D and added new data and recommendations to the Warnings section of paroxetine’s prescribing information.” Category D is the FDA’s second-highest category for risk of birth defects.

News that the American Dental Association issued “interim guidance” on infant formula and fluoride last month, urging parents and caregivers to avoid fluoridated water when reconstituting infant formula, comes to us via the Environmental Working Group.

EWG is trying to get Wal-Mart to stop selling Nursery Water, the leading fluoridated water for babies. The concern is over the risk for enamel fluorosis, a disruption in tooth enamel formation that occurs only during tooth development in early childhood, before the teeth appear.

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