When Frequent, Uncontrollable Episodes of Crying and Laughing are a Medical Condition

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Certain neurologic conditions or brain injury can affect the signals that tell a person’s body when or how much to cry or laugh.

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Thursday, May 17, 2018




When Frequent, Uncontrollable Episodes of Crying and Laughing are a Medical Condition




Laughing and crying are normal human responses to emotion. But sudden, frequent, and uncontrollable episodes of crying or laughing that are exaggerated or don’t match how a person feels could be a sign of a medical condition called PseudoBulbar Affect (PBA).



What is PBA?
Certain neurologic conditions or brain injury can affect the signals that tell a person’s body when or how much to cry or laugh. This can trigger episodes of crying or laughing that are sudden and exaggerated (more intense or lasting longer than expected) or mismatched (not fitting the situation).iPBA affects about 2 million people in the United States, including men and women who have experienced a traumatic brain injury (TBI) or are living with certain neurologic conditions like stroke; Alzheimer’s disease (AD) and dementia; multiple sclerosis (MS); Parkinson’s disease; and amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.iiSymptoms of PBA are often overlooked or mischaracterized as depression. While these conditions can often coexist — meaning some people can have both PBA and depression — both conditions are manageable and should be independently diagnosed.i



How is PBA Treated?
The “short circuit” in the brain that triggers these involuntary episodes of crying or laughing was first described in medical literature over 130 years ago by Charles Darwin, but it is only in recent years that a treatment has become available.ivNUEDEXTA (dextromethorphan hydrobromide/quinidine sulfate) capsules were approved in 2010 and are the only pharmaceutical agent approved by the Food and Drug Administration for the treatment of PBA.Prior to treatment, patients experienced on average 30-50 episodes of uncontrolled laughing and/or crying per week. By the end of the 12-week clinical trial, patients on NUEDEXTA reported 82% fewer episodes, compared to patients on placebo who experienced a 45% reduction in PBA episodes. In addition, 51% of patients on NUEDEXTA experienced episode-free days, compared to 29% of patients taking placebo, in the final two weeks of the 12 week trial.iii


Find Out More About NUEDEXTA



Delanie's PBA Story





"I am very thankful to whoever came up with NUEDEXTA. It has made a positive impact on my life and helped lessen the number and severity of my episodes." Delanie Stephenson, 39, a stroke survivor living with PseudoBulbar Affect (PBA)
Delanie Stephenson, a married mother of two, was only 33 when she experienced a life-altering stroke. When she emerged from a medically induced coma, she began having difficulty controlling her laughing and crying. She initially thought the episodes were a temporary side effect of the stroke, but they lingered for months.
"I would have sudden laughing fits while at the movies, during church services, while we were out shopping," she says. "It wasn’t typical; it was uncontrollable and more exaggerated than I actually felt. It was like my brain was doing what it wanted to do, not what I wanted it to do."
She reached out to her neurologist in search of an answer. After hearing Delanie’s symptoms, her neurologist diagnosed her with PseudoBulbar Affect (PBA) and prescribed NUEDEXTA.
"To have a name for what I was going through was amazing," Delanie says. "I was so relieved to find out there was something to explain what I was experiencing and a way to treat my PBA episodes."
Delanie has been taking NUEDEXTA for five years. It has helped lessen the number of PBA episodes and their severity.
What is NUEDEXTA approved for?NUEDEXTA® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.NUEDEXTA is only available by prescription.


Important Safety Information
Before you take NUEDEXTA, tell your doctor:
If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.If you have had heart disease or have a family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.If you have myasthenia gravis.While taking NUEDEXTA, call your doctor right away: If you feel faint or lose consciousness.If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA. If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.If you feel dizzy, since it may increase your risk of falling.If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.The most common side effects of NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 800-FDA-1088
Please see NUEDEXTA Brief Summary of Important Facts.
IMPORTANT FACTS
ABOUT NUEDEXTANUEDEXTA® is approved for the treatment of PseudoBulbar Affect (PBA). PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.NUEDEXTA is only available by prescription.DO NOT TAKE NUEDEXTA IF YOUAre taking other drugs that contain quinidine, quinine, or mefloquine.Have a history of allergic reactions or intolerance (including hepatitis, low blood cell count, or lupus-like syndrome) to quinidine, quinine, or mefloquine.Have ever been allergic to dextromethorphan (commonly found in some cough medicines).Are taking, or have taken, drugs called monoamineoxidase inhibitors (MAOIs). MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.Have had heart disease or have a family history of heart rhythm problems.Are taking drugs such as thioridazine and pimozide that interact with NUEDEXTA and cause changes in heart rhythm.
If you have certain heart conditions or are taking certain medicines, your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.NUEDEXTA MAY CAUSE SERIOUS SIDE EFFECTSStop NUEDEXTA if these side effects occur:
Symptoms including lightheadedness, chills, fever, nausea, or vomiting may be a sign of an allergic reaction, or thrombocytopenia which if left untreated can be fatal.
Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
Abnormal heart. Stop NUEDEXTA and tell your doctor immediately as it may be a sign of Torsadesde Pointes. In some cases NUEDEXTA can interact with antidepressants causing confusion, high blood pressure, fever, restlessness, sweating, and shivering. Tell your doctor if you experience any of these side effects.
Tell your doctor if you’ve ever been diagnosed with my asthenia gravis. If so, NUEDEXTA may not be right for you.
POSSIBLE COMMON SIDE EFFECTS OF NUEDEXTA
The most common side effects in patients taking NUEDEXTA were diarrhea, dizziness, cough, vomiting, weakness and swelling of feet and ankles.If you are unsteady on your feet or if you have fallen before, be careful while taking NUEDEXTA to avoid falling.This is not a complete list of side effects.Tell your doctor if you have any side effect that bothers you or does not go away.
TAKING NUEDEXTA ALONG WITH OTHER MEDICATIONS
Tell your doctor about all medicines, supplements, and vitamins you take before starting NUEDEXTA.
NUEDEXTA may interact with other medications causing potentially serious side-effects, and may affect the way NUEDEXTA or these other medicines work. Your doctor may adjust the dose of these medicines if used together with NUEDEXTA:
Antidepressants.
Certain heart or blood pressure medications. Your doctor may test your heart rhythm before you start NUEDEXTA.
Digoxin.
Alcohol. Limit alcohol intake while taking NUEDEXTA.
These are not the only medicines that may cause problems when you take NUEDEXTA.
Before starting a new medicine, remind your doctor if you are taking NUEDEXTA.
ADDITIONAL IMPORTANT INFORMATION
If your PBA symptoms do not improve or if they get worse, contact your healthcare provider.NUEDEXTA has not been studied in patients less than age 18 or in pregnant women. Tell your doctor if you may be pregnant.Nursing mothers: Because many drugs are excreted in human milk, discuss with your healthcare provider if you are nursing.Take NUEDEXTA exactly as your doctor prescribes it.You and your healthcare provider should talk regularly about whether you still need treatment with NUEDEXTA. NUEDEXTA may be taken with or without food.Keep NUEDEXTA and all medicines out of reach of children.The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients.NEED MORE INFORMATION?
This information about NUEDEXTA is important but is not complete. To learn more:Talk to your healthcare provider or pharmacist.Visit www.Nuedexta.com for FDA-approved Prescribing Information or call 1-855-4NUEDEX (1-855-468-3339).
©2018 Avanir Pharmaceuticals, Inc. All rights reserved. AVANIR and NUEDEXTA are trademarks or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries. NUE-0934-EML-0518


i Miller A, Pratt H, Schiffer RB. Pseudobulbar affect: the spectrum of clinical presentations, etiologies and treatments. Expert Rev. Neurother. 11(7), 1077–1088 (2011).
ii Work SS, Colamonico JA, Bradley WG, Kaye RE. Pseudobulbar affect: an under-recognized and under-treated neurological disorder. Adv Ther. 2011;28:586-601.
iiiPioro EP, Brooks BR, Cummings J, et al. Dextromethorphan plus ultra-low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010;68:693-702.
ivDarwin C. The expression of the emotions in man and animals. New York and London, D Appleton and company, 1872.

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