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Birth-Defect Risks to Pregnant Women Taking Zoloft

Pregnancy should be one of the happiest times of a woman's life. However, it can be a physically and emotionally challenging time, especially for mothers with clinical depression. Even without a pre-existing mental-health challenge like depression, the physical symptoms of pregnancy like nausea and fatigue, the hormonal changes, and normal fears and anxieties about the baby can bring on the blues.

Women on medication like Zoloft, Prozac, Paxil and others to smooth out the symptoms of depression face a serious dilemma in the face of pregnancy: whether to continue their antidepressants. At first glance it may seem obvious that an expectant mother would stop taking such a drug because of the developing infant, but it is never quite that simple.

Depression in and of itself can be disabling, causing fatigue, sadness, hopelessness and inertia, and sometimes in response, people with depression do not take good care of themselves, shortchanging nutrition, sleep and exercise. Alarmingly, people with depression may even try to self-medicate with alcohol or drugs. Of course none of these risks paint a good picture for a pregnant woman, who needs to take even better than usual care of herself and her child during pregnancy.

In a serious case of depression, the doctor may consider advising the pregnant patient to continue the medication into pregnancy because of the risks that going off the medication may pose to the mother and fetus if severe symptoms of depression emerge during pregnancy. But such advice must be balanced against the potential for negative side effects and birth defects from the specific medication being taken.

One medication that has come under fire in this circumstance is Zoloft, pharmaceutical giant Pfizer's brand name for the antidepressant drug sertraline. Sertraline is a "selective serotonin reuptake inhibitor" or SSRI for short, a drug that treats depression by increasing the level of serotonin in the brain. Serotonin is a brain chemical that is known to stabilize mood when present at normal levels.

Personal injury lawsuits are pending nationwide against Pfizer for birth defects allegedly caused by taking Zoloft during pregnancy. Studies have been done on the effects of SSRIs generally and Zoloft specifically on the developing fetus with varying results, but some of serious concern.

Some of the conditions in newborns that have been possibly linked to maternal Zoloft use include:

  • Septal heart defects
  • Holes in the heart
  • Persistent pulmonary hypertension in newborns, or PPHN, a potentially fatal lung condition
  • Irritability
  • Trouble with feeding or breathing

The lawsuits reportedly allege that Pfizer knew or should have known of the congenital defects from Zoloft ingestion during pregnancy, that Zoloft is a dangerous and defective drug, and that proper warnings were not given.

The Federal Food and Drug Administration, or FDA, issued a public health advisory in 2006 about the dangers of SSRIs, including Zoloft, during pregnancy, and the difficulty in treating pregnant women with serious depression. The FDA cited two studies:

  • The first found that women who stopped taking antidepressants during pregnancy were five times more likely to have depression relapses than women who stayed on medication during pregnancy.
  • The second found that SSRIs may raise the risk of PPHN by six times when taken in the last half of pregnancy.

The health care community, personal injury attorneys and concerned consumers will watch the outcomes of the lawsuits with keen interest. In the meantime, a woman with depression facing pregnancy should question her physician in detail about the risks and benefits of taking an antidepressant in order to make a well informed decision.