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Septal Heart Defects and SSRIs

Posted on July 08, 2014 in Birth Defects

Several years ago reports were released regarding antidepressant medications and the link to birth defects. In 2009, noted by WebMD, a study reported that women who take antidepressants during pregnancy may risk that their baby will have a heart defect. And the risk of the baby being born with a defect is greater when the used antidepressant is a selective serotonin reuptake inhibitor (SSRI). The same goes for moms who switch to an SSRI antidepressant medication early in the pregnancy. Many women experience hormonal changes during pregnancy are prescribed antidepressants as a result. However, it was not clear in the study if all SSRI medications led to the increased risk of heart defect.

In 2005, the U.S. Food and Drug Administration (FDA) issued warnings about Paxil, an antidepressant similar to the more widely used Zoloft, Celexa, or Prozac. The study found no link between heart defects in babies whose mothers were taking Prozac or Paxil. But, it did find a correlation in mothers taking Celexa or Zoloft. That study, which examined more than 400,000 babies between 1996 an 2003, found that “septal heart defects occurred in 0.5 percent of children born to mothers who did not take antidepressants and 0.9 percent of children born to mothers who did.”

Septal heart disease is when a hole occurs between the heart's chambers. According to the National Heart, Lung, and Blood Institute (NIH), the hole changes the normal flow of blood through the heart, which can result in several complications throughout life. While it used to be a life-threatening condition (and it is still considered severe), children who now have a hole in their heart tend to live on to adulthood. Some, according to the NIH, can “live normal, active lives because their heart defects close on their own or have been repaired.”


Around the world, selective serotonin reuptake inhibitors (often called SSRIs) are some of the most commonly prescribed depression medications. In the United States, one of the most popular SSRIs given to patients with depression is Zoloft, which has been linked to dangerous birth defects when taken by pregnant mothers. A new study from the British Medical Journal is the latest authority to lend credence to the risks posed by antidepressants.

The researchers, who reviewed a series of seven studies, found that the risk of persistent pulmonary hypertension of the newborn was different based on the period of the pregnancy in which the mother took the medication. When SSRIs like Zoloft were taken in the later stages of a pregnancy, mothers faced an increased risk that their children would be affected by PPHN.

Although researchers noted that the risk was comparatively low, PPHN is a serious condition that no parent wants to face. In this condition, the baby's lungs are unable to properly exchange oxygen and carbon dioxide. As a result, a newborn could have very low blood oxygen levels, possibly causing damage to organs.


Isotretinoin, also known as Accutane and one of the most effective medications for acne, is reported to cause severe birth defects to an exposed fetus. Because of this, the U.S. Food and Drug Administration created the computer-based risk management program iPledge, requiring women to review educational materials, complete tests and pledge to use two forms of birth control prior to using the drug.

However, a recent report indicates that the iPledge program been less than successful, and a small study suggests the focus be placed on more highly effective birth control methods. Dr. Eleanor Bimla Schwarz, director of the Women's Health Services Research Unit of the Center for Research on Health Care at the University of Pittsburgh and the senior author of the study, stated, “What we found is that people need a clear message about what birth control would be most effective, and currently the iPledge materials don't make it clear to most women who enroll in the program.” Schwarz also told Reuters Health that women who take isotretinoin need more information on IUDs and implants to better protect themselves from pregnancy.

While the iPledge website clearly states the high risk of severe birth defects that isotretinoin can have on an exposed fetus, earlier studies also indicate that the program and previous initiatives have had “limited or no success to prevent pregnancies among women taking the drug.” And according to the American College of Obstetricians and Gynecologists, IUDs and contraceptive implants are the most effective reversible contraceptive, and “do not require ongoing effort on the part of the user for long-term and effective use.” In an email to Reuters Health, a spokesperson for the FDA stated that the agency cannot comment on this specific study or the validity of the statements.


Morning Sickness Drug Returns

Posted on July 02, 2013 in Birth Defects

Recently, the FDA has approved the return of a prescription medicine used to treat morning sickness during pregnancy that was taken off the market about 30 years ago after leading to hundreds of lawsuits that claimed it led to birth defects.

The pill that has been brought back from the dead was called Bendectin in the past, but will now be sold as Diclegis. The FDA never actually stated that the pill was unsafe, but the pharmaceutical company who distributed the pill decided to pull it once the litigation costs outweighed profit.

During the time Bendectin was on the market, over 300 lawsuits were filed against Merrell Dow, the company behind it. These various lawsuits claimed that the drug led to babies being born with deformities. However, no direct link was made between Bendectin and the birth defects it supposedly caused. There was no scientific evidence.


In 1983, the FDA approved Depakote to treat certain issues with the central nervous system. It has successfully treated or controlled such disorders as epileptic seizures and episodes of manic or bipolar behavior. This medicine can also be prescribed for migraine headaches. It is primarily used as a mood stabilizer and anti-convulsant, which has also provided relief for certain off label conditions.

After years of tests and research, there have been recent studies that have identified issues with this medication. Unfortunately, this is a far too common, because even the vigorous tests that were run by the FDA can miss potentially fatal side effects. In 2009, the FDA warned pregnant mothers about certain congenital birth defects such as a cleft palate, spina bifida, malformed hands and autism.

Again, in 2011, the FDA notified consumers of other possible side effects. The results of studies by Emory University have given cognitive tests to children from 3 to 6 years old. The results have shown that children of mothers who took Depakote while pregnant tended to score lower on IQ tests than mothers who took other anti-seizure medications during pregnancy.

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