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Zoloft Overview What is Zoloft?
Zoloft (sertraline) is in a class of medications called Selective Serotonin Reuptake Inhibitors (SSRIs). Zoloft is used to treat:
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:
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.
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.
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.
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.
What Should I Discuss with my Healthcare Provider Before Taking Zoloft.
You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. Talk with your doctor about this risk. While you are taking Zoloft you will need to be monitored for worsening symptoms of depression and/or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks.
Do not use Zoloft if you are using pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with Zoloft. You must wait at least 14 days after stopping an MAO inhibitor before you can take Zoloft. After you stop taking Zoloft, you must wait at least 14 days before you start taking an MAOI. Before taking Zoloft, tell your doctor if you have:
If you have any of these conditions, you may not be able to use Zoloft, or you may need a dosage adjustment or special tests.
FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking Zoloft, do not stop taking the medication without first talking to your doctor. It is not known whether Zoloft passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Can Other Medicines or Food Affect Zoloft?
In order to avoid dangerous interactions with any medicines you might be taking, tell your healthcare professional about all prescription and non-prescription medicines, vitamins, and herbal supplements that you take. Tell your healthcare professional about all medications you take that affect bleeding or that treat anxiety, mental illness, depression, or heart problems. If you plan to drink alcohol while taking Zoloft, talk to your healthcare professional.
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