SSRIs are among the most prescribed medications in the United States and are the most poplar antidepressants prescribed in recent years. Little data was available to determine the risks on fetuses, thus many women were under the assumption that the drugs were safe. However, studies began to question that safety record.

Most of the concern focused on paroxetine, known by the brand name Paxil. Earlier studies resulted in Paxil being downgraded to a Category D pregnancy drug, meaning studies have shown the drug can cause birth defects if used during pregnancy.

The latest study suggests other SSRIs, including Zoloft, Celexa, Lexapro and Prozac, may be just as dangerous to developing fetuses. Researchers reviewed data from nationwide birth registries covering 11 years. The cohort included 635,583 babies, of whom 6,976 were exposed to SSRIs during the first trimester. The data showed that babies exposed to SSRIs were at greater risk for major cardiovascular anomalies than babies who were not exposed to SSRIs during gestation.

Specific defects linked to SSRI exposure include ventricular septal defects and right ventricular outflow tract defects. There was also a risk for neural tube defects.

The study also found that fetal alcohol syndrome disorders were nearly 10 times mere common in SSRI-exposed babies than in unexposed children. Therefore, the researchers advised, special attention should be given to alcohol use in pregnant women who use SSRIs.

Source: MedScape

SOURCE: Paxil and Pregnancy › Study raises more concerns about SSRIs and birth defects

This month, 13 Americans are suing Grunethal GmbH and companies now merged into GlaxoSmithKline and Sanofi, claiming the drug companies conspired to withhold the results of studies that showed their drug Thalidomide, used to treat morning sickness in pregnant women, caused birth defects, including missing and malformed limbs.

The plaintiffs were all born with birth defects between 1957 and 1962. The drug companies claim that the birth defects associated with Thalidomide were known in Europe, and that they could not have happened in the United States because the drug was only used in a limited clinical trial. The drug companies allege that the link between birth defects and Thalidomide was not known until 1961, however the lawsuits claim the companies were aware of the risks as early as 1955.

It’s taken 50 years for the victims of Thalidomide to seek justice, but lawsuits are already mounting against manufacturers of another class of drugs that studies show may cause serious birth defects – selective serotonin reuptake inhibitors, or SSRIs. These antidepressants are among the most prescribed medications in America, and many women are under the belief that these drugs are safe to use during pregnancy.

The truth is drug companies do receive complaints about their medication but are often slow to share the news. For example, women who used the SSRI Paxil during pregnancy and delivered babies with serious brain, heart and lung defects found out too late that their babies could have been spared injury if only they had been made aware of the possible risks associated with the drug.

It took several complaints for the Food and Drug Administration (FDA) to order stronger warnings on Paxil use during pregnancy. Many of those mothers are waiting for their day in court.

Source: Business Week

SOURCE: Paxil and Pregnancy › Drug companies should not hide risk for birth defects

Researchers looked at data collected between 1990 and 1996 from a larger study investigating heart disease risk, and pulled data from 555 women who were 24 years old on average when they gave birth. Researchers studied that data for links between race, preterm birth and pre-pregnancy depressive mood. The data showed that 18.1 percent of the 249 black women gave birth prematurely – at less than 37 weeks gestation – compared to 8.5 percent among the 306 white participants.

The prevalence of pre-pregnancy depression was also higher among black women compared with white women – 9.4 percent compared to 7.2 percent, respectively. Researchers say the findings suggest that a woman’s overall health must be viewed when considering reproductive outcomes.

But it also points to a need for health care professionals to address a woman’s emotional presence especially if she is pregnant or considering pregnancy. Depression during pregnancy can be dangerous for both the mother and her unborn child, leading to poor nutrition; dependence on alcohol, drugs or cigarettes; and suicidal behavior, all of which can contribute to premature birth. Psychotherapy and antidepressants are a viable option but doctors and patients must both be advised of the potential risks that antidepressants carry. Some SSRIs commonly used to treat depression, such as Paxil, can increase the risk of birth defects, especially heart defects, which have led manufacturers like GlaxoSmithKline to include warnings of potential birth defects on the medication’s label.

Source: Reuters

SOURCE: Paxil and Pregnancy › Depressed, black women at higher risk of delivering prematurely

The findings are based on a study published in the online journal Fertility & Sterility. It is touted as one of the first studies to investigate the effects of antidepressants on sperm quality. While fertility wasn’t a direct focus of the study, “we can infer that as many as half of men taking SSRIs have a reduced ability to conceive,” says Dr. Peter Schlegel the study’s senior author.

More than a third of participants in the study also reported significant changes in erectile function and ejaculatory difficulties. Both sexual function and compromised sperm DNA returned to normal one month after discontinuation of the antidepressant.

Antidepressants also can have a more serious effect on fertility. Women who take antidepressants during the first trimester of pregnancy are at greater risk of having a baby with serious birth defects. Studies show that while a number of birth defects have resulted from use of antidepressants, paroxetine (Paxil, Seroxat) poses the greatest risk to an unborn child. Those defects include cardiac defects such as ventricular septal defects, pulmonary hypertension, omphalocele, and craniosynostosis.

Those who are pregnant or are considering pregnancy should consult with their doctors about any medications, including antidepressants, they are taking. In some cases, doctors may recommend an alternative that is safer for the unborn child and won’t interfere with conception.

SOURCE: Paxil and Pregnancy › Paxil, Seroxat may interfere with man’s ability to conceive