Zoloft Information and Warnings
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UPDATED: Jul 16, 2021
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Zoloft is FDA approved to treat major depression (MDD), social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, premenstrual dyphoric disorder (PMDD), and obsessive-compulsive disorder (OCD) in adults and OCD in 6 to 17 year olds. Zoloft is not approved for the treatment of depression in children under 18, yet many physicians continue to prescribe Zoloft for this.
There are many concerns about the effect on infants when their mothers take Zoloft and other antidepressants. Patients who have stopped using Zoloft have reported an alarming array of symptoms, or side effects, that begin soon after the drug is discontinued. Infants whose mothers have taken the drug during pregnancy have also suffered from Zoloft withdrawal. An early study also showed sleep disturbances in these infants.
Even more disturbing is the fact that antidepressants have been linked to congenital malformations in infants exposed to them during pregnancy. Zoloft, as well as other SSRI antidepressants, operates by raising levels of serotonin, which plays a role in the development of the fetus. Changing the levels in the mother’s body might have serious side effects. Studies have not been conclusive and the risk is small, but several studies have linked these drugs to particular birth defects. A study published in the New England Journal of Medicine in 2007 found that there was an increased risk of omphalocele, a birth defect involving the abdominal wall and intestines in infants whose mothers took Zoloft. Another study published on the same day found a link between all SSRIs and three kind of birth defects: anecephaly and craniosynostosis, 2 forms of brain defect, and omphalocele.
These aren’t the only risks for infants. A 2006 study released by the University of California at San Diego found that infants whose mothers had taken SSRI antidepressants (including Zoloft) after the 20th week of pregnancy were at an increased risk for a sometimes deadly infant lung disorder called persistent pulmonary hypertension (PPHN). The FDA released an alert about the results of this study on July 19, 2006, but concluded at that time that the study results were inconclusive.
Even though the percentage of infants who suffer from these events is low, no mother wants her child to be the one who suffers from one of them. Mothers and their doctors must have accurate information to decide if the benefits of Zoloft are outweighed by the risks to the child. The antidepressant drug manufacturers, including Zoloft’s manufacturer Pfizer, have been accused of intentionally misleading doctors and the public about the benefits of SSRI drugs. As early as 2005, an article published in the British Medical Journal revealed that studies on the effectiveness of antidepressant showed that they were not significantly more effective than placebos. This means that although some people do get better when treated for depression, it may be because they are told they’re being helped. Almost as many people taking placebos, or “sugar pills,” get better as those who take antidepressants. These conclusions were later verified in a Canadian study.
In 2006, the Wall Street Journal revealed that the majority of the authors of a study claiming that many pregnant women who stop taking antidepressants during pregnancy relapse into depression, were receiving money from the antidepressant drug manufactures and had failed to reveal the connection (as required) when the study was published. In 2008, the New England Journal of Medicine published a study showing that the results of antidepressant effectiveness studies had also been misrepresented in U.S. publications. Studies showing that antidepressants were ineffective were usually not published or were published with misleading results.
All of these actions on the part of antidepressant drug manufacturers and researchers who work for them has caused women and their doctors to make decisions about birth defect risks based on incorrect and incomplete information. These companies could be held liable for any harm to infants that results from withholding information and misrepresenting the risks of discontinuing antidepressant use during pregnancy.
There has also been much concern that Zoloft and other antidepressants cause suicide or suicidal thoughts. The FDA posted a warning on its website at the beginning of February 2005 and required Zoloft’s manufacturer, Pfizer, to include a warning on the label that Zoloft was among the drugs that “increased the risk of suicidal thinking and behavior in short-term studies of adolescents and children.”
Later information indicated that Zoloft might pose a similar threat to adults and the FDA issued a Public Health Advisory warning on July 1, 2005 warning that studies had raised the possibility of increased risk of suicidal behavior in adults treated with antidepressants.
Check out the following articles for more information about Zoloft, filing a Zoloft lawsuit and finding a Zoloft attorney.
- For more information about Zoloft, see Drug Overview: Zoloft Side Effects and Claims.
- For more information about Zoloft side effects, see Zoloft Side Effects
- To find out more about the FDA warning, see Zoloft Side Effects and Risks
- If you would like to learn more about Zoloft lawsuits, see Zoloft Lawsuits, Litigation & Lawyers
- To learn more about Zoloft attorneys and how to find one, see Hiring a Zoloft Attorney and Lawyer