What is the most important information I should know about PAXIL?

Generic Name: paroxetine (pa ROX a teen)

Brand Names: Paxil, Paxil CR, Pexeva,

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, Paxil especially if you are a child or young adult. Talk with your doctor about this risk. While you are taking Paxil 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 of treatment.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself. Paxil may cause heart defects or serious, 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 Paxil, do not stop taking the medication without first talking to your doctor. Do not take Paxil together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

What is Paxil?

• Paxil is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paxil affects chemicals in the brain that may become unbalanced.
• Paxil is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
• Paxil may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Paxil?

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are a child or young adult. Talk with your doctor about this risk. While you are taking Paxil 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 Paxil if you are using pimozide (Orap), thioridazine (Mellaril), 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 Paxil. You must wait at least 14 days after stopping an MAO inhibitor before you can take Paxil. After you stop taking Paxil, you must wait at least 14 days before you start taking an MAOI.

Before taking Paxil, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;
• seizures or epilepsy;
• bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use Paxil, or you may need a dosage adjustment or special tests.

FDA pregnancy category D. Paxil may cause heart defects or serious, 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 Paxil, do not stop taking the medication without first talking to your doctor. Paxil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Contact Bailey & Galyen at 800 529 8008, if you or your loved one has been effected by taking Paxil Drug.

Additional information concerning is available on FDA's Web site at: Public Health Advisory and CDER Information Sheets

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