Prasugrel

Last Reviewed: Sep 11, 2024

Warnings


Prasugrel (Effient) Risks, Warnings, and Complications


Prasugrel can cause or worsen health problems in some people. Talk to your doctor or pharmacist about other treatment options if you are at an increased risk of adverse reactions from this drug.

  • RISK OF BLEEDING: Prasugrel is a thienopyridine antiplatelet agent. It lowers the risk of blood clot formation by preventing platelet aggregation. Taking this medicine increases the risk of serious bleeding. Clinical trials such as TRITON-TIMI 38, TIMI Major, and TIMI Minor have found that bleeding is more common on prasugrel compared to clopidogrel. The increased bleeding risk is highest when treatment is first started. Other risk factors for fatal and intracranial bleeding include:

    Age 75 years or older (prasugrel is generally not given to patients 75 years of age and older except in high-risk situations where the patient has diabetes or a history of myocardial infarction (heart attack) and the benefits are greater than the risks. 

    Patients with a body weight less than 60 kg (132 lbs). A lower (5 mg) maintenance dose may be given to such individuals.

    Patients who have undergone coronary artery bypass graft surgery (CABG) or other surgical procedures.

    Patients with an increased risk of bleeding, for example, due to recent surgery, recent trauma, active peptic ulcer disease, recent or recurrent gastrointestinal bleeding, or severe hepatic impairment.

    Patients taking other medications that also increase the risk of bleeding, for example, oral anticoagulants (blood thinners) and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) and fibrinolytic agents. 

    Prasugrel is contraindicated in patients with active pathological bleeding and those who have had a prior transient ischemic attack (TIA or mini-stroke) or stroke. 

  • CABG RELATED BLEEDING RISK: The risk of bleeding is higher in patients who undergo coronary artery bypass graft surgery (CABG) or heart bypass surgery while on prasugrel. This drug is therefore discontinued at least 7 days before the planned CABG.

  • DISCONTINUATION OF PRASUGREL: The optimum duration of treatment with prasugrel is unclear. However, in patients who undergo percutaneous coronary intervention (PCI) and stent placement, stopping treatment too soon can lead to an increased risk of blood clot formation in the stent, heart attack, and death. 

    Do not stop taking prasugrel without your doctor’s approval. Your health care professional may, however, discontinue prasugrel if you develop active bleeding, have a transient ischemic attack (TIA) or stroke, or need to undergo elective surgery. 

  • THROMBOTIC THROMBOCYTOPENIC PURPURA: Thrombotic thrombocytopenic purpura (TTP) has been reported after the use of prasugrel. This is a serious, potentially fatal condition that requires emergency treatment. TTP can develop after a short time on prasugrel (less than 2 weeks). Seek immediate medical attention if you develop symptoms such as fever, decreased urination, confusion, headache, or purple patches in your skin.


Precautions Before Starting Prasugrel (Effient)

Tell your doctor if you have ever had an allergic reaction to prasugrel, similar antiplatelet drugs such as clopidogrel (Plavix) or ticlopidine (Ticlid), any of the active or inactive ingredients in prasugrel tablets, or any other medications. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of your medications, including prescription medications, over-the-counter medicines, vitamins, dietary supplements, and herbal products. This can help avoid possible interactions between prasugrel and your other medicines.

Give your doctor a complete medical history. Prasugrel may not be safe for people with certain medical conditions such as easy bruising or bleeding, recent surgery, recent trauma, stomach ulcers, gastrointestinal bleeding, brain bleeds, stroke, transient ischemic attack (TIA or mini-stroke), intestinal polyps, diverticulitis, liver disease, and end-stage renal disease (severe renal impairment). 

Tell your doctor if you are pregnant, could be pregnant, plan to get pregnant, or are breast-feeding.

Talk to your doctor about the benefits versus risks of taking prasugrel if you are over 75 years of age. Discuss dosage adjustment with your provider if you have low body weight (less than 60 kg or 132 lbs).

Precautions During Use of Prasugrel (Effient)

Keep all your medical and lab appointments while on prasugrel. 

Tell your doctor if you become pregnant while on prasugrel.

Tell all your healthcare providers you are on prasugrel, especially before any surgery, including dental procedures. Prasugrel can lead to an increased risk of bleeding. Your health care providers will likely ask you to temporarily stop this medication at least 7 days before planned surgical procedures.

You are likely to bruise and bleed more easily and have more prolonged bleeding while on prasugrel. You may also have nosebleeds. Seek emergency medical care if you develop clinically significant bleeding (bleeding that is severe, unexplained, uncontrollable, or long-lasting). Also, seek medical care urgently for pink or brown-colored bloody urine; black, tarry stools; blood in vomit or coffee grounds vomit; coughing up blood clots or blood; unexplained bruises or bruises that are growing in size.

Prasugrel (Effient) Drug Interactions

Concomitant use of certain medicines can affect how prasugrel works. Possible interactions with other medicines can increase the risk of severe adverse events. The following medications can have drug interactions with prasugrel:

  • Anticoagulants (blood thinners) such as warfarin (Jantoven, Coumadin) and heparin that also increase bleeding risk
  • Other medications that affect platelet function or are used to treat or prevent blood clots
  • Regular or chronic use of nonsteroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin), and naproxen (Aleve)
  • Opioid drugs such as codeine, morphine (Astramorph, Kadian), hydrocodone (Zohydro ER, Hysingla, in Vicodin), oxycodone (in Percocet, in Roxicet, others), and fentanyl (Duragesic, Subsys)

The above list may not include all the potential drug interactions of prasugrel. Give your doctor or pharmacist a complete list of your medications. This includes prescription drugs, nonprescription drugs, dietary supplements, and herbal remedies. Also, tell your healthcare professional if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.