Cymbalta

Since September 2005, information has been emerging that certain antidepressants may cause birth defects, including cardiac (heart), pulmonary (lung), craniosynostosis (skull defect) and infant omphalocele (abdominal wall defects).

New York, NY: Cymbalta, the brand name for duloxetine, has been recently linked to an increased risk of birth complications and serious birth defects including Persistent pulmonary hypertension of the newborn (PPHN), which occurs when a newborn’s circulation system does not adapt to breathing outside the womb.

Cymbalta is used to treat major depressive disorder and pain caused by nerve damage associated with diabetes. It is in a class of drug known as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). SSNRIs are similar to SSRIs which have been linked to serious side effects in newborn babies including PPHN and heart defects.

A study published last year in the New England Journal of Medicine found that infants with mothers who took prescription antidepressants like Cymbalta after the 20th week of pregnancy were six times more likely to be born with PPHN or heart defects than infants with mothers who did not take such antidepressants.

Without SSRIs, the number of babies born with PPHN is one to two infants per 1,000 births. However, in babies exposed to SSRIs during the second have of pregnancy, the number increases to between six and twelve infants per 1,000 births.

Meanwhile, a study published in Epidemiology (November, 2006) found that the use of SSRIs (which are similar to SNRIs) early in pregnancy raises the risk of congenital malformations in infants. According to the study, the risk of having a baby with congenital malformations is 34 percent higher for women who used SSRIs during pregnancy. Furthermore, women who used SSRIs during the second or third months of their pregnancies had an 84 percent higher risk of having an infant with a congenital malformation. This is because the second and third month of pregnancy are key times for organ development.

Yet another study published in the American Journal of Obstetrics and Gynecology (June, 2006) found that one-third of women included in the study who took SSRIs during pregnancy experienced some form of birth complication, including having a fetus die, premature delivery, having newborns with seizures, or delivering an underweight baby.

According to the study, almost 20 percent of women who took SSRIs gave birth prematurely compared with around 12 percent for those not taking SSRIs. Just over one percent taking SSRIs suffered fetal death compared with 0.4 percent who did not take the antidepressants.

These studies and subsequent lawsuits have not seemed to hurt Eli Lilly, the drug manufacturer. On January 26, 2007 Bank of America analysts said that they expect Cymbalta sales should reach $405 million in the first quarter. According to health information company IMS Health, sales of their big sellers Prozac and Cymbalta brought in $12.5 billion in 2005.

The Food and Drug Administration has classified Cymbalta as pregnancy category C. Category C means that the drug can be harmful to an unborn baby and can also pass through breast milk and harm nursing babies. Make sure you notify your doctor if you are pregnant or planning on becoming pregnant and are taking Cymbalta. The long-term effects of exposure to Cymbalta are still not known.

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