" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
Priftin Consumer (continued)
This medication may cause urine, sweat, saliva, or tears to turn reddish. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.
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 unlikely but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), painful/swollen joints, dark/bloody urine, easy bleeding/bruising, unusual tiredness, signs of a new infection (such as fever, persistent sore throat).
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
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 Priftin (rifapentine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking rifapentine, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); 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: HIV infection, a certain blood disorder (porphyria), liver disease, alcohol use.
Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Rifapentine may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.
During pregnancy, this medication should be used only when clearly needed. When this drug is taken during the last few weeks of pregnancy, the risk of bleeding in both mother and infant may be increased. Tell your doctor immediately if you notice any bleeding in your newborn. Discuss the risks and benefits with your doctor.
It is unknown if rifapentine passes into breast milk. However, similar drugs pass into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.
Additional Priftin Information
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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