- Prasugrel can cause significant, sometimes fatal, bleeding [See Warnings and Precautions and ADRs]
- Do not use this drug in patients with active pathological bleeding or a history of transient ischemic attack or stroke [See Contraindication]
- In patients at least 75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered [See Use in Specified Populations]
- Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery.
- Additional risk factors for bleeding include: body weight less than 60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of NSAIDs.
- Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of prasugrel.
- If possible, manage bleeding without discontinuing prasugrel. Discontinuing prasugrel, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events [see Warnings and Precautions].
FDA and Industry Communications
Patient Counseling Information
Updated January 2018