Paxil and PPHN: The risk of Birth Defects versus the risk of Depression

Houston, TXMore organizations are recommending that women who are pregnant avoid taking Paxil due to the risk of Primary Pulmonary Hypertension of the Newborn (PPHN).

However, as they make their recommendations some doctors say that the risk of relapsing into depression is also a serious cause for concern, leaving expectant mothers to decide whether the benefits of Paxil outweigh the risks.

Recently, The American College of Obstetricians and Gynecologists (ACOG) issued a news release stating that women who are pregnant or planning on becoming pregnant should avoid the use of Paxil when possible because of the high risk of birth defects, including PPHN.

Paxil (known generically as paroxetine) is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression, anxiety, obsessive-compulsive disorder, premenstrual dysphoric disorder, and post traumatic stress disorder. In addition to PPHN, Paxil has also been linked to congenital malformations, withdrawal symptoms in newborns that can last weeks after birth, and possibly long-term motor skill developmental problems.

SSRIs are the most commonly prescribed of the antidepressants and work by affecting a person's serotonin levels. Serotonin is a chemical that plays a role a person's mood, sleep behavior, appetite, and memory. After serotonin is released from the nerve cell, any serotonin that is not used is removed. SSRIs work by preventing the removal of excess serotonin, thereby increasing the amount of serotonin in a person's brain.

Some questions have come up as to whether or not it is safe for women to stop taking Paxil and other SSRIs because they run the risk of relapsing into depression. A study published last year in the Journal of the American Medical Association (JAMA, February 2006) found that discontinuing the medication had a huge impact on the risk of a relapse. However, most of the authors of the study were paid consultants or lecturers for the makers of antidepressants. In fact, the authors of the study did not disclose at least 60 ties to drug companies.

According to a Wall Street Journal Report (July 11, 2006, found at healthcoalition.ca), "In the case of antidepressant use during pregnancies, the industry-paid opinion leaders have become dominant authorities in the field. They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed."

Based on what these experts with their ties to the drug industry are saying, women are making decisions about whether or not to take antidepressants, not knowing that they are being given information that is most likely biased.

Around the same time that the JAMA study came out, a different study of antidepressants was published in the New England Journal of Medicine. This study showed that women who took SSRIs late in their pregnancy had six times the risk of giving birth to a baby with PPHN. The author of this study receives research funding from generic drug makers, however this study was funded by government grants.

Paxil is classified Category D by the US Food and Drug Administration, meaning that the drug has been found to cause harm to human fetuses. Previously, Paxil was Category C, meaning that the drug caused harm to fetuses in animal studies, but had not yet been fully studied in humans.

Women who are taking Paxil and are pregnant or planning on becoming pregnant should sit down with their doctor to discuss the risks and benefits of continuing with this medication.