"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Norpace Consumer (continued)
Dry mouth, constipation, nausea, abdominal pain/gas/bloating, blurred vision, dizziness, dry nose/eyes/throat, and urination problems (such as difficulty urinating or unusual frequent urge to urinate) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but serious side effects occur: symptoms of low blood sugar (such as shakiness with unusual hunger/headache/sweating), signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine), muscle weakness, worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).
Seek immediate medical attention if any of these rare but serious side effects occur: fainting, faster/more irregular heartbeat, severe dizziness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Norpace (disopyramide phosphate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking disopyramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, glaucoma, kidney disease, liver problems, myasthenia gravis, urinary problems (such as due to enlarged prostate, urinary retention).
This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist that you are using this medication.
Disopyramide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using disopyramide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using disopyramide safely.
This drug may cause low blood sugar (hypoglycemia), especially if you have diabetes, heart failure, decreased kidney/liver function, or nutrition problems. Tell your doctor immediately if you have symptoms of low blood sugar including sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. If you have diabetes, your diabetes medication, exercise program, or diet may need to be adjusted.
Older adults may be more sensitive to the side effects of this drug, especially urination problems and QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Rarely, disopyramide may cause early labor during pregnancy. Discuss the risks and benefits with your doctor.
This medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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