What is Zoloft?

Zoloft (sertraline) is in a class of medications called Selective Serotonin Reuptake Inhibitors (SSRIs). Zoloft is used to treat:

• Depression
• Obsessive-compulsive disorder (OCD)
• Panic disorder
• Posttraumatic stress disorder (PTSD)
• Premenstrual dysphoric disorder
• Social anxiety disorder (SAD)

Zoloft is made by Pfizer Pharmaceuticals, and was approved by the U.S. Food and Drug Administration (FDA) in 1991.

Special Instructions for Taking Zoloft Oral Concentrate

When taking Zoloft oral concentrate, dilute it in only ½ cup of water, ginger ale, lemon/lime soda, or orange juice. Take immediately after mixing. Tell your doctor if you are allergic to latex, because the dropper used to measure Zoloft oral concentrate contains natural rubber.

Zoloft FDA Alert - Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Selective Serotonin Reuptake Inhibitors (SSRIs, such as Zoloft) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include:

• restlessness
• hallucinations
• loss of coordination
• fast heartbeat
• increased body temperature
• fast changes in blood pressure
• overactive reflexes
• diarrhea
• coma
• nausea
• vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Zoloft FDA Alert - Antidepressants and Pregnant Women

In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) to have PPHN, when compared to babies born to mothers who did not take antidepressants during pregnancy.

The FDA has announced that it plans to further examine the role of SSRIs in babies with PPHN.

Talk to your healthcare professional if you are taking Zoloft and are pregnant, or are planning to become pregnant. You and your healthcare professional can decide the best way to treat your depression during pregnancy.

More information on antidepressants is available from the FDA here.

Zoloft and the Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Zoloft-maker Pfizer Pharmaceuticals has since added a black box warning to Zoloft's prescribing information in response to the FDA advisory. Click here for more information on this advisory.

In June 2005, the FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, such as Zoloft. The FDA highlighted that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here for more information on this advisory.

Who Should Not Take Zoloft?

Never take Zoloft while taking another drug that treats depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking these two drugs close in time can result in serious (and sometimes fatal) reactions including high body temperature, coma, and seizures (convulsions).

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Also, never take Zoloft if you are taking Orap (pimozide), a drug used to treat Tourette's disorder. Doing so can result in serious heartbeat problems.

Finally, never take Zoloft oral concentrate if you are taking Antabuse (disulfiram), a medicine used to treat alcoholism. Zoloft oral concentrate contains alcohol.