Use of PEXEVA®
PEXEVA® (paroxetine mesylate) is approved for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD), panic disorder (PD), and generalized anxiety
disorder (GAD) in adults.
Depression is a serious medical condition that in some people can lead to suicidal thoughts. As with any medication, there are benefits and risks with PEXEVA. It is important to discuss these
with your doctor.
IMPORTANT SAFETY INFORMATION
What Is The Most Important Information You Should Know About PEXEVA®?
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should discuss with the healthcare professional right away any worsening depression symptoms, suicidal thinking or behavior, or unusual changes in behavior. PEXEVA is not approved for use in children and teens.
Who should not take PEXEVA®?
What should I tell my healthcare professional about before taking PEXEVA®?
Also talk with your healthcare professional about the following precautions:
- Talk with your doctor about your medical conditions, including kidney or liver problems,
diabetes, seizures, or bi-polar disease, and your alcohol use.
- Tell your doctor if you have glaucoma (high pressure in the eye).
- If you are pregnant or plan to become pregnant. The use of paroxetine during the first 3
months of pregnancy has been shown to increase the risk of severe health problems in the
unborn baby. Some of these health problems affect the baby's heart. Use during the last 3
months of pregnancy may cause dangerous lung complications in newborns. For these
reasons, women who are pregnant or who plan to become pregnant should discuss other
treatment choices with their doctor. Women who are breast feeding should also talk to
their doctor before taking PEXEVA.
- Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid
changes in heart rate and blood pressure. These may be signs of a rare but serious side
effect called Serotonin Syndrome.
What side effects may occur with PEXEVA®?
- All patients taking antidepressants should be watched closely for signs that their
condition is getting worse or that they are becoming suicidal, especially when they first
start therapy, or when their dose is increased or decreased. Patients should also be
watched for becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Such
symptoms should be reported to the patient's doctor right away. Please read the
accompanying Medication Guide.
- Before starting PEXEVA, tell your doctor if you're taking or plan to take any prescription
or over-the-counter drugs, including migraine headache medication (triptans), other
antidepressants or antipsychotics, herbal preparations, and nutritional supplements, to
avoid a potentially life-threatening condition.
- Taking PEXEVA with aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen),
warfarin, or other drugs that affect coagulation may increase the risk of bleeding events.
- Some studies have shown that taking PEXEVA with Tamoxifen for breast cancer may
reduce the efficacy of Tamoxifen.
- When people suddenly stop using or quickly lower their daily dose of PEXEVA,
discontinuation symptoms may occur. Talk to your doctor before discontinuing or
reducing your dose of PEXEVA.
- Until you see how PEXEVA affects you, be careful doing such activities as driving a car or operating machinery.
- You should avoid drinking alcohol while on PEXEVA.
As discussed above and in the Medication Guide, serious side effects can occur with PEXEVA.
The most common side effects that have been reported with PEXEVA include nausea,
sleepiness, weakness, dizziness, feeling anxious, trouble sleeping, sexual problems, sweating,
shaking, not feeling hungry, dry mouth, constipation, infection, and yawning.
Be sure to tell your doctor how you are feeling.
If you have any questions about PEXEVA, call your doctor. Be sure to let your doctor know if you notice any unusual changes while taking PEXEVA and never stop your medicine or change your dose before speaking with your doctor.
Please see accompanying Medication Guide for PEXEVA and the full Prescribing Information
including BOXED WARNINGS-Suicidality and Antidepressant Drugs.