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Precautions and Warnings With Prasugrel

If you have any active bleeding, such as a bleeding stomach, you should not take prasugrel. Precautions and warnings for the antiplatelet drug also apply to people with liver disease, people who have had a stroke, and women who are pregnant or breastfeeding. This drug should be avoided by anyone who is allergic to prasugrel or any of its active ingredients.

What Should I Tell My Healthcare Provider?

Prior to taking prasugrel (Effient®), talk to your healthcare provider if you have:
Also, let your healthcare provider know if you:
  • Will be having surgery
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding.
Make sure to tell your healthcare provider about any other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Prasugrel Warnings and Precautions

Precautions and warnings to be aware of prior to taking prasugrel include the following:
  • One of the most serious side effects of prasugrel is bleeding, including potentially fatal internal bleeding. People at the highest risk for this problem include those who:
    • Are 75 years of age or older
    • Undergo a heart bypass surgery
    • Weigh 132 pounds or less
    • Have suffered a recent physical trauma
    • Have had a recent surgery
    • Have recent or recurrent gastrointestinal bleeding or ulcers
    • Have severe liver disease
Prasugrel should not be given to any individual with active bleeding.
  • In general, the risks of prasugrel outweigh the benefits for people age 75 or older, except in special groups, such as those with diabetes or a history of a previous heart attack. Before recommending this medication to elderly individuals, healthcare providers must carefully consider the benefits and risks for the individual.
  • Let your healthcare provider know if you develop any signs of bleeding, such as:
    • Easy bruising
    • Cuts or scrapes that are slow to stop bleeding
    • Black, tarry stools; bright-red blood in the stool; or vomiting of blood (signs of gastrointestinal bleeding)
    • Signs of bleeding in the brain, such as vision or speech changes, weakness or numbness in an arm or leg, or a severe headache.
  • Prasugrel should not be given to people who have had a previous stroke or transient ischemic attacks (TIAs, commonly known as "mini-strokes"). Studies suggest that this medication increases the risk of strokes in such people.
  • This medicine should not be given to people who are likely to need heart bypass surgery. If a person already taking prasugrel needs to have a bypass, the procedure should be postponed for seven days if possible in order to decrease the risk of life-threatening bleeding.
  • Prasugrel should be stopped ahead of time for any elective surgery. Ask your healthcare provider when you should stop and restart it.
  • Prasugrel may interact with a few different medications (see Drug Interactions With Prasugrel).
  • At this time, it is not entirely clear how long people should continue to take prasugrel, and different healthcare providers may have different opinions on this matter. Your healthcare provider will take into account your particular situation when recommending how long you should take it. Stopping treatment too soon may increase your risk of heart attacks, blood clots in your stent, and death.
  • Medications like prasugrel have been linked to a serious condition known as thrombotic thrombocytopenic purpura (TTP). Be sure to let your healthcare provider know right away if you develop any symptoms of TTP, such as:
    • Pinpoint bruising on the skin
    • Fever
    • A general ill feeling
    • Low blood platelets (found using a blood test)
    • Kidney problems
    • Headache
    • Confusion
    • Seizures
    • Coma
    • Abdominal pain (stomach pain)
    • An irregular heart rhythm (arrhythmia).
  • Prasugrel is a pregnancy Category B medication, which means it is probably safe for use during pregnancy, although the full risks are currently unknown (see Effient and Pregnancy for more information).
  • At this time, it is unknown if prasugrel passes through breast milk in humans. If you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Effient and Breastfeeding for more information).
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