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Zoloft FDA News

Zoloft treats depression and is linked to potential side effects such as angle closure glaucoma and heart and lung conditions in newborns. Doctors provide prescription guidelines for pregnant women taking the medication.

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In October 2004, the U.S. Food & Drug Administration (FDA) asked manufacturers of certain antidepressant drugs to include in their labeling a “boxed” warning statement that recommends close observation for worsening depression or thoughts of suicide in adult and pediatric patients treated with these agents. Zoloft (sertraline) was included in this warning, and the labeling was subsequently changed to reflect this. 1

Zoloft Safety Communications

July 2014 – Angle Closure Glaucoma

In July 2014, the FDA instructed pharmaceutical companies to add a new warning on the labels of medicines, like Zoloft, that treat symptoms of major depressive disorder. The new requirement warns users about a possible complication called angle-closure glaucoma that can be brought on by pupillary dilation, a side effect certain drugs. 2 Some projections indicate that as many as 5.3 million people could develop primary angle-closure glaucoma by 2020. 3

Angle-closure glaucoma symptoms may include:

  • Redness or swelling in or near the eye
  • Eye pain
  • Vision changes

Many people will never develop angle-closure glaucoma. If you have any questions, speak with your primary physician or a qualified specialist.

Heart and Lung Condition in Newborns

In a safety announcement, the FDA updated the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). A previous advisory in July 2006 was based on one study, and the FDA had since seen conflicting results making it unclear of the potential risks to using SSRIs during pregnancy given that these drugs are commonly used to treat depression during this time.

Patients were advised to consult their healthcare professionals and to discuss the risks and benefits of treatment. Doctors prescribing the medication should refer to the guidelines for managing depression during pregnancy. 4

  1. U.S. Food & Drug Administration. “Postmarket Drug Safety Information for Patients and Providers: Worsening Depression and Suicidality in Patients Being Treated With Antidepressants,” (Aug 7, 2009) FDA.gov. Accessed July 30, 2013 

  2. U.S. Food & Drug Administration. “Drugs to Treat Major Depressive Disorder — Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER).” (Aug. 15, 2014) FDA.gov. Accessed Oct. 23, 2014. 

  3. See, Jovina L. S. “Management of angle closure glaucoma.” (Jan. 2011) Indian Journal of Ophthalmology. Accessed Oct. 23, 2014. 

  4. U.S. Food & Drug Administration. “FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies.” (Jan 9, 2012) FDA.gov. Accessed July 30, 2013.