- BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Paroxetine and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline is started or when the dose is changed.
- You should not drive, operate heavy machinery, or do other dangerous activities until you know how paroxetine affects you.
Do not take paroxetine if you:
- Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. Do not take an MAOI within 14 days of stopping paroxetine unless directed to do so by your healthcare provider. Do not start paroxetine if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider. People who take paroxetine close in time to an MAOI may have serious or life-threatening side effects. Get medical help right away if you have any of these symptoms:
- High fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- Confusion
- loss of consciousness (pass out).
- Take thioridazine or pimozide. Do not take thioridazine or pimozide together with paroxetine because this can cause serious heart problems or sudden death.
- Are allergic to paroxetine.
- Are pregnant. paroxetine is not for pregnant women. Paroxetine can harm your unborn baby.
Call your healthcare provider right away if you have any of the following symptoms:
- Suicidal thoughts or actions: paroxetine, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when paroxetine is started. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you: Attempts to commit suicide; acting on dangerous impulses; acting aggressive or violent; thoughts about suicide or dying; new or worse depression; new or worse anxiety or panic attacks; feeling agitated, restless, angry, or irritable; trouble sleeping; an increase in activity or talking more than what is normal for you or other unusual changes in behavior or mood.
- Serotonin Syndrome. This condition can be life-threatening and may include: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
- Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken at the same time as paroxetine. If you are taking tamoxifen, tell your healthcare provider before starting paroxetine.
- Abnormal bleeding: paroxetine may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen, or aspirin.
- Visual symptoms.
- Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this. Symptoms may include: headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems.
- Bone Fractures: Women who take paroxetine may have a higher risk of bone fractures.
- Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
- Seizures or convulsions.
- Restlessness: Women who take paroxetine may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking paroxetine.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Paroxetine (10 mg, 20 mg, 30 mg, 40 mg) is approved by the FDA for treatment of Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Order, and Posttraumatic Stress Disorder (PTSD). Paroxetine (7.5 mg) is approved by the FDA under the brand name Brisdelle® for the treatment of moderate to severe vasomotor symptoms associated with menopause, and is not approved for the treatment of any psychiatric condition.
Before starting paroxetine, tell your healthcare provider if you have:
- liver or kidney problems
- bipolar disorder or mania
- low sodium levels in your blood
- glaucoma (high pressure in the eye)
- have or had seizures, convulsions, or bleeding problems
- have any other medical conditions
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines such as migraine headache medication (triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements. If you take paroxetine, you should not take any other medicines that contain paroxetine, including Paxil® , Paxil CR® , and Pexeva® .
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
The most common possible side effects of paroxetine include:
- Headache
- tiredness
- nausea
- and vomiting
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of paroxetine. Please read the Medication Guide within the full Prescribing Information, including information about the BOXED WARNING, before taking paroxetine.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
Product names referenced herein are trademarks of their respective owners.
This Important Safety Information has been adapted from the Prescribing Information for Effexor XR®.
- BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, teens, and young adults under the age of 25 compared to placebo. 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. Venlafaxine is not approved for use in children and teens.
- 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.
- Before taking venlafaxine, tell your doctor and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take, including those to treat migraines or psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome.
- Venlafaxine may raise blood pressure in some patients. Your blood pressure should be controlled before starting treatment and should be monitored regularly.
- Taking venlafaxine with aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or other blood thinners may increase the risk of bleeding events.
- Some people are at risk for visual problems such as eye pain, changes in vision, or swelling or redness around the eye. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.
- When people suddenly stop using or quickly lower their daily dose of venlafaxine, serious discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of venlafaxine.
Do not take venlafaxine if you:
- Have a history of suicidal thoughts or attempts, unless venlafaxine is used under the direction of a psychiatrist
- Have a history of self-injurious behavior, unless venlafaxine is used under the direction of a psychiatrist
- Have a history of bipolar disorder, unless venlafaxine is used under the direction of a psychiatrist
- Have a history of manic or depressive episodes, unless venlafaxine is used under the direction of a psychiatrist
- Have uncontrolled high blood pressure
- Have a history of serotonin syndrome
- Take medication for depression, bipolar disorder, or anxiety-including a TCA, SSRI, or SNRI (see the full list of potential drug interactions here in the drug interactions section)
- Take MAOIs or who have taken MAOIs in the previous 2 weeks
- Have a history of long QT syndrome or who are taking drugs that lengthen the QT interval
- Have moderate-to-severe liver disease
- Have moderate-to-severe kidney disease
- Are pregnant, trying to become pregnant, or nursing
- Are under the age of 18
People with bleeding disorders, or who are taking medications that increase their risks of bleeding, should discuss this with their doctor before taking venlafaxine. In most cases, an alternative treatment strategy will be used. Until you see how venlafaxine affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking venlafaxine.
In clinical studies, the most common side effects of venlafaxine (reported in at least 5% of patients and at least twice as often as with placebo) were:
- Constipation
- Dizziness
- Dry mouth
- Insomnia
- Loss of appetite
- Nausea
- Nervousness
- Sexual side effects
- Sleepiness
- Sweating
- Weakness
Contact your Rory-affiliated physician and your primary healthcare provider if you experience any new symptoms after beginning venlafaxine for hot flashes.
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Venlafaxine is a prescription medicine that is FDA approved for the treatment, in adults, of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia.
Venlafaxine is recommended by the North American Menopause Society (NAMS) for the treatment of hot flashes. While clinical data supports the use of venlafaxine for the treatment of hot flashes, this is not an FDA-approved use of the drug.
Tell your Rory-affiliated provider if you have any of the following prior to taking venlafaxine:
- Thoughts of doing harm to yourself at any point in the past
- History of mental illness in you or your family (e.g., depression, psychosis, bipolar disorder, manic depression)
- Glaucoma
- Irregular heartbeats (arrhythmia)
- High blood pressure
- All medications taken now and within the past two weeks
- History of illicit drug use
- History of drug addiction
- History of serotonin syndrome
- A list of all your current medical problems, including, but not limited to, liver disease, kidney disease, heart disease, seizure disorder, and bleeding disorders
- Allergy or negative reaction to venlafaxine or other serotonin norepinephrine reuptake inhibitors (SNRI) under different names or any components (e.g., Cymbalta, Effexor, Fetzima, Pristiq, venlafaxine, desvenlafaxine, duloxetine, levomilnacipran)
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information, including the BOXED WARNING, for complete safety information.
