Impact of Pseudobulbar Affect (PBA)

Actor portrayal of patient with Pseudobulbar Affect, or PBA, crying symptoms

PBA’s impact on patients is substantial¹

Pseudobulbar Affect (PBA) presents a considerable, incremental burden to a patient with an underlying neurologic condition or injury, such as:

Stroke
Dementia or Alzheimer disease
Traumatic brain injury (TBI)

Parkinson's disease
Amyotrophic lateral sclerosis (ALS)
Multiple sclerosis (MS)

Although PBA is diagnosed secondary to another neurologic condition, it is a separate, treatable disorder that is not to be taken lightly. Uncontrolled laughing and/or crying episodes have a substantial impact—resulting in embarrassment for the patient and their family. Because of fear of having a PBA episode in public, patients may restrict their social interactions.² Your patients may not say something to you about their PBA symptoms for many reasons, but one question can help them open up to you about PBA’s impact on their life.

Why your patients aren’t talking about their PBA symptoms

Patients experiencing sudden, frequent, involuntary laughing and/or crying episodes may not talk to you about their symptoms for several reasons. According to the healthcare providers in the video below, these reasons may include:

1

They’re embarrassed by their outbursts.

PBA can strike anytime, anywhere. Because episodes are uncontrollable, patients may not be able to stop laughing and/or crying in inappropriate settings.

2

They may think it’s a symptom of a previously diagnosed condition.

For example, since crying is common in depression, patients may attribute their PBA crying symptoms to their depression. They may not bring up these symptoms because they don't realize that PBA is a separate condition.

3

They don’t realize that their symptoms are manageable.

If they don't know that treatment is available to reduce their episodes, they may not think to ask for help.

4

They don’t understand what’s happening to them.

Laughing and crying are normal displays of emotion, but in patients with PBA, they can be exaggerated or incongruent with their underlying mood. So, patients may not realize that what they're experiencing is part of a real, neurologic condition.

Just because a patient doesn’t say something to you doesn’t mean that PBA isn’t impacting them.

Identifying Patients with PBA

Two healthcare providers share real patient stories, discussing why they believe their patients didn’t say something sooner about their uncontrollable laughing and/or crying.

Download a transcript of this video.

Ask the question, understand the impact

In one web-based survey (N=1052) of patients with an underlying neurologic condition associated with PBA or their nonpaid caregivers, respondents who described their uncontrollable laughing and/or crying episodes as “extremely” or “very” burdensome had experienced²:

Patients with PBA symptoms (n=399) were defined as those who scored 13 or greater on the Center for Neurologic Study-Lability Scale (CNS-LS).*

*The CNS-LS was validated as a measure of perceived episode frequency in amyotrophic lateral sclerosis and multiple sclerosis populations. The scale does not confer a PBA diagnosis.^3,4

To find out if PBA is impacting your patient, simply ask them or their caregivers the following question:

Can you tell me about any changes in your laughing or crying since your [underlying neurologic diagnosis or brain injury]?

For more information about diagnosing PBA, visit our Diagnosing PBA page.

Co-Pay Card & Sample Requests

CO-PAY SAVINGS CARD

Share this card to help your patients save on their NUEDEXTA prescription and refills. By enrolling, your commercially insured patients may pay as little as $0 for a 90-day supply, or $20 for a 30-day supply.

Print Co-Pay Savings Card Restrictions apply. Most commercially insured patients pay as little as $0 for a 90-day supply or $20 for a 30-day supply. Benefit cap applies regardless of co-pay amount.

NUEDEXTA sample bottle for PseudoBulbar Affect (PBA) patients

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Eligible healthcare providers can request a free 10-day sample of NUEDEXTA for appropriate patients.

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References: 1. Ahmed A, Simmons Z. Pseudobulbar affect: prevalence and management. Ther Clin Risk Manag. 2013;9(1):483-489. 2. Colamonico J, Formella A, Bradley W. Pseudobulbar affect: burden of illness in the USA. Adv Ther. 2012;29(9):775-798.  3. Moore SR, Gresham LS, Bromberg MB, Kasarkis EJ, Smith RA. A self report measure of affective lability. J Neurol Neurosurg Psychiatry. 1997;63(1):89-93.  4. Smith RA, Berg JE, Pope LE, Callahan JD, Wynn D, Thisted RA. Validation of the CNS emotional lability scale for pseudobulbar affect (pathological laughing and crying) in multiple sclerosis patients. Mult Scler. 2004;10(6):679-685.

IMPORTANT SAFETY INFORMATION and INDICATION for NUEDEXTA^® (dextromethorphan HBr and quinidine sulfate)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Quinidine and Related Drugs: NUEDEXTA contains quinidine and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.
Hypersensitivity: NUEDEXTA is contraindicated in patients with a history of NUEDEXTA-, quinine-, mefloquine-, or quinidine-induced thrombocytopenia, hepatitis, bone-marrow depression, lupus-like syndrome, or known hypersensitivity to dextromethorphan (e.g., rash, hives).
MAOIs: NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping NUEDEXTA before starting an MAOI.
Cardiovascular: NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, heart failure, patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), patients with complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block.

Thrombocytopenia and Other Hypersensitivity Reactions:
Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs.

Hepatotoxicity: Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Discontinue immediately if this occurs.

Cardiac Effects: NUEDEXTA causes dose-dependent QTc prolongation. QT prolongation can cause torsades de pointes–type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating NUEDEXTA in patients at risk for QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3 to 4 hours after the first dose. Some risk factors include use with CYP3A4 inhibitors or drugs that prolong QT interval, electrolyte abnormalities, bradycardia, or left ventricular hypertrophy or dysfunction. If patients taking NUEDEXTA experience symptoms that could indicate the occurrence of cardiac arrhythmias (e.g., syncope or palpitations), NUEDEXTA should be discontinued, and the patient further evaluated.

Concomitant Use of CYP2D6 Substrates: NUEDEXTA inhibits CYP2D6 and may interact with other drugs metabolized by CYP2D6. Adjust dose of CYP2D6 substrates as needed.

Dizziness: NUEDEXTA may cause dizziness. Take precautions to reduce the risk of falls.

Serotonin Syndrome: Use of NUEDEXTA with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk of “serotonin syndrome.”

Anticholinergic Effects of Quinidine: Monitor for worsening in myasthenia gravis.

Adverse Reactions: The most common adverse reactions (incidence of ≥3% and two-fold greater than placebo) in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence.

These are not all the risks for use of NUEDEXTA.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION.

INDICATION

NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurologic disease or injury.