"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
DDAVP Injection Consumer (continued)
Infrequently, desmopressin may affect your blood pressure. It may cause an increase or decrease in your blood pressure. A temporary drop in your blood pressure may result in dizziness and a fast heartbeat. Ask your doctor for more details, especially if you have heart problems or high or low blood pressure. Tell your doctor promptly if changes in your blood pressure occur or if any of these symptoms occur.
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.
Desmopressin can infrequently cause a low level of sodium in the blood, which can be serious and possibly life-threatening. Drinking too much water or other fluids increases the risk of having a low level of sodium in the blood. Therefore, follow your doctor's directions for limiting fluids. Seek immediate medical attention if you have any of these unlikely but serious symptoms of a low level of sodium in the blood: loss of appetite, severe nausea, vomiting, severe headache, muscle weakness/spasms/cramps, sudden weight gain, unusual tiredness, unusual severe drowsiness, mental/mood changes (such as confusion, hallucinations, irritability), loss of consciousness, seizures, slow/shallow breathing.
Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, weakness on one side of the body, slurred speech, sudden vision changes.
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 DDAVP Injection (desmopressin acetate injection) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using desmopressin, 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, a low level of sodium in the blood (current or past hyponatremia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high or low blood pressure, heart disease (such as blocked blood vessels in the heart), conditions that may increase your risk of fluid/mineral imbalance (such as cystic fibrosis, heart failure), the urge to drink too much water without being thirsty, history of blood clots.
If you have lost too much body water (become dehydrated), your doctor will correct that condition first before starting treatment with desmopressin.
This drug may 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. Alcohol can also interfere with how well desmopressin works.
Tell the doctor immediately if you develop any illness that can cause water/mineral imbalance (including fever, diarrhea, vomiting, infections such as the flu) or if you experience conditions that require drinking more fluids (for example, exposure to very hot weather, strenuous exercise, persistent sweating). The doctor may need to stop or adjust desmopressin treatment, especially in children and older adults.
Children may be more sensitive to the side effects of this drug, especially water/mineral imbalance and a low level of sodium in the blood.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for water/mineral imbalance and a low level of sodium in the blood while using this drug.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. 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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