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Clinical Trials Experience

The following serious adverse reactions are also discussed elsewhere in the labeling:

• Bleeding [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Thrombotic thrombocytopenic purpura [see WARNINGS AND PRECAUTIONS]

Safety in patients with ACS undergoing PCI was evaluated in a clopidogrel-controlled study, TRITON-TIMI 38, in which 6741 patients were treated with Effient (prasugrel tablets) (60 mg loading dose and 10 mg once daily) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year). The population treated with Effient (prasugrel tablets) was 27 to 96 years of age, 25% female, and 92% Caucasian. All patients in the TRITON-TIMI 38 study were to receive aspirin. The dose of clopidogrel in this study was a 300 mg loading dose and 75 mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another drug and may not reflect the rates observed in practice.

Drug Discontinuation

The rate of study drug discontinuation because of adverse reactions was 7.2% for Effient (prasugrel tablets) and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient (prasugrel tablets) and 1.4% for clopidogrel).

Bleeding

Bleeding Unrelated to CABG Surgery - In TRITON-TIMI 38, overall rates of TIMI Major or Minor bleeding adverse reactions unrelated to coronary artery bypass graft surgery (CABG) were significantly higher on Effient (prasugrel tablets) than on clopidogrel, as shown in Table 1.

Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)

Figure 1 demonstrates non-CABG related TIMI Major or Minor bleeding. The bleeding rate is highest initially, as shown in Figure 1 (inset: Days 0 to 7) [see WARNINGS AND PRECAUTIONS].

Bleeding rates in patients with the risk factors of age ≥ 75 years and weight < 60 kg are shown in Table 2.

Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38)

Bleeding Related to CABG - In TRITON-TIMI 38, 437 patients who received a thienopyridine underwent CABG during the course of the study. The rate of CABG-related TIMI Major or Minor bleeding was 14.1% for the Effient (prasugrel tablets) group and 4.5% in the clopidogrel group (Table 3). The higher risk for bleeding adverse reactions in patients treated with Effient (prasugrel tablets) persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleeding^a (TRITON-TIMI 38)

Bleeding Reported as Adverse Reactions - Hemorrhagic events reported as adverse reactions in TRITON-TIMI 38 were, for Effient (prasugrel tablets) and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%, 0.5%), subcutaneous hematoma (0.5%, 0.2%), post-procedural hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies

During TRITON-TIMI 38, newly diagnosed malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel and clopidogrel, respectively. The sites contributing to the differences were primarily colon and lung. It is unclear if these observations are causally-related or are random occurrences.

Other Adverse Events

In TRITON-TIMI 38, common and other important non-hemorrhagic adverse events were, for Effient (prasugrel tablets) and clopidogrel, respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions (0.36%, 0.36%), and angioedema (0.06%, 0.04%). Table 4 summarizes the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Effient (prasugrel tablets) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders — Thrombocytopenia, Thrombotic thrombocytopenic purpura (TTP) [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]

Immune system disorders — Hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS]

Warfarin

Coadministration of Effient (prasugrel tablets) and warfarin increases the risk of bleeding [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Non-Steroidal Anti-Inflammatory Drugs

Coadministration of Effient (prasugrel tablets) and NSAIDs (used chronically) may increase the risk of bleeding [see WARNINGS AND PRECAUTIONS].

Other Concomitant Medications

Effient (prasugrel tablets) can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see CLINICAL PHARMACOLOGY].

Effient (prasugrel tablets) can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H₂ blockers [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 10/6/2011
This monograph has been modified to include the generic and brand name in many instances.