Antidepressants Increase Risk of Birth Defects With First Trimester Use: Study

A new study involving birth defect side effects associated with antidepressant use during pregnancy found that selective serotonin reuptake inhibitors (SSRIs), like Zoloft and Celexa, can increase the risk of heart defects when taken in the first trimester.

The study, which was published in the September 2009 edition of the British Medical Journal, looked at data from half a million births between 1996 and 2003, finding that the use of SSRIs during the first three months of pregnancy could double the risk of septal heart defects in newborns.

Dutch researchers conducted a population-based cohort study, looking at nationwide data in Denmark on prescriptions and birth defects. They concluded that the risk of septal heart defects increased from 0.5% for infants whose mothers did not take the antidepressants to 0.9% when the mother used an SSRI during the first three months of pregnancy. Mothers who took more than one SSRI during their first trimester had a 2.1% chance of giving birth to a child with a heart defect, more than four times higher than women who did not take the drugs.

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Septal heart defects occur when the wall between the right and left side of the heart is not correctly formed. They are the most common form of heart defect found among babies born to women taking SSRIs. In many cases, the defects will correct themselves over time, but sometimes they require surgery to treat.

The study looked specifically at sertraline, used in the brand name drugs Zoloft and Lustral, and citalopram, which is used in the brand name drug Celexa. All are part of the SSRI class of drugs, which are used to treat depression, obsessive compulsive disorder, panic disorders and social phobias.

The risk of SSRI antidepressant birth defects has been a known issue for several years. In 2006, the FDA released a public health advisory that antidepressant side effects could cause serious injury to infants if taken by the mother after the 20th week of pregnancy, including a six-fold increase in the risk of the child suffering from Persistent Pulmonary Hypertension in Newborns (PPHN).

In December 2005, the FDA released an alert about the risk of birth defects from Paxil, another type of SSRI antidepressant, after studies showed the drug could increase the risk of heart problems in infants when taken during the first three months of pregnancy. At that time, the agency also required the GlaxoSmithKline, the drug’s maker, to update the warning label to include the information about the risk of birth defects from Paxil side effects.

A number of Paxil lawsuits over birth defects have been filed against GlaxoSmithKline, alleging that the company was aware of the risk and failed to adequately warn doctors and consumers. Although the drug maker has maintained that they did nothing wrong, testimony presented last week during some of the first Plavix trials suggested that a Glaxo official determined as early as 2001 that Paxil was responsible for an adverse event report involving a heart problem in a newborn.


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