Important Safety Information
What is the most important information I should know about Effient?
Effient® (prasugrel) can cause bleeding. If you have unexplained or excessive bleeding while on Effient, contact your doctor right away as some bleeding can be serious, and sometimes fatal. Do not take Effient if you currently have abnormal bleeding, such as stomach or intestinal bleeding, bleeding in your head, or have a history of stroke, or “mini-stroke” (also known as transient ischemic attack or TIA), or if you are allergic to prasugrel or any of the ingredients in Effient.
Get medical help right away if you suddenly have slurring of speech, weakness or numbness in one part of your body, blurry vision, and/or severe headache. These may be symptoms of a stroke or TIA. If you have a stroke or TIA while taking Effient, your doctor will probably stop your Effient.
Before having any surgery, you should talk to your doctor about stopping Effient. If possible, Effient should be stopped at least 1 week (7 days) before any surgery, as instructed by the doctor who prescribed Effient for you.
You may also have a higher risk of bleeding if you take Effient and you: a) are age 75 or older, b) weigh less than 132 pounds, c) are taking anticoagulants (eg, warfarin) or regular daily use of NSAIDs, d) have had recent trauma, such as an accident or surgery, e) have severe liver problems, f) have moderate to severe kidney problems, or g) have a stomach ulcer.
Call your doctor right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, bleeding that is severe or you cannot control, pink or brown urine, red or black stool, bruises that happen without a known cause or get larger, cough up blood or blood clots or vomit blood or your vomit looks like coffee grounds.
Do not stop taking Effient without talking to the doctor who prescribes it for you. People who are treated with angioplasty and have a stent, and stop taking Effient too soon, have a higher risk of a blood clot in the stent, having a heart attack, or dying.
What should I tell my doctor before taking Effient?
Tell your doctor about all of your medical conditions, allergies, and medicines you are taking.
What are the possible side effects of Effient?
Bleeding is the most common side effect of Effient.
TTP, a rare but life-threatening condition, has been reported with Effient, sometimes after a short time (less than 2 weeks). Get medical attention right away if you develop the following unexpected symptoms of TTP: fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or dotted with purple spots.
Serious allergic reactions can happen with Effient, or if you have had a serious allergic reaction to the medicines Plavix® (clopidogrel) or ticlopidine. Get medical help right away if you get any of these symptoms of a severe allergic reaction: swelling or hives of your face, lips, in or around your mouth, or throat, trouble breathing or swallowing, chest pain or pressure, dizziness or fainting.
Other side effects may occur.
Effient is available by prescription only. For more information, talk to your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about Effient, please see the Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.