Aggrastat Side Effects

The most common drug-related adverse event reported during therapy with Aggrastat when used concomitantly with heparin and aspirin, was bleeding (usually reported by the investigators as oozing or mild). The incidences of major and minor bleeding using the TIMI Criteria in the PRISM PLUS (Platelet Receptor Inhibition for Ischemic Syndrome Management - Patients Limited by Unstable Signs and Symptoms) and RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) studies are shown as follows: See Table 3.

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There were no reports of intracranial bleeding in the PRISM PLUS study for Aggrastat in combination with heparin or in the control group (which received heparin). The incidence of intracranial bleeding in the RESTORE study was 0.1% for Aggrastat in combination with heparin and 0.3% for the control group (which received heparin). In the PRISM PLUS study, the incidences of retroperitoneal bleeding reported for Aggrastat in combination with heparin, and for the control group were 0.0% and 0.1%, respectively. In the RESTORE study, the incidences of retroperitoneal bleeding reported for Aggrastat in combination with heparin, and the control group were 0.6% and 0.3%, respectively.
Female patients and elderly patients receiving Aggrastat with heparin or heparin alone had a higher incidence of bleeding complications than male patients or younger patients, respectively. The incremental risk of bleeding in patients treated with Aggrastat in combination with heparin over the risk in patients treated with heparin alone was comparable regardless of age or gender. No dose adjustment is recommended for these populations (see Other Patient Populations under Dosage & Administration).
Patients treated with Aggrastat, with heparin, were more likely to experience decreases in platelet counts than the control group. These decreases were reversible upon discontinuation of Aggrastat. The percentage of patients with a decrease of platelets to <90,000 cells/mm³ was 1.5%. The percentage of patients with a decrease of platelets to <50,000 cells/mm³ was 0.3%. Platelet decreases have been observed in patients with no prior history of thrombocytopenia upon readministration of GP IIb/IIIa receptor antagonists.
The most frequent drug-related nonbleeding side effects reported with Aggrastat, administered concomitantly with heparin, occurring at an incidence of >1% were nausea (1.7%), fever (1.5%), and headache (1.1%); nausea, fever and headache occurred at an incidence of 1.4%, 1.1% and 1.2%, respectively, in the control group.
In clinical studies, the incidences of adverse events were generally similar among different races, patients with or without hypertension, patients with or without diabetes mellitus, and patients with or without hypercholesterolemia.
The overall incidence of non-bleeding adverse events was higher in female patients (compared to male patients) and older patients (compared to younger patients). However, the incidences of non-bleeding adverse events in these patients were comparable between the Aggrastat with heparin and the heparin alone groups. (See previously mentioned for bleeding adverse events.)
The following additional adverse reactions have been reported in post-marketing experience: Bleeding: intracranial bleeding, retroperitoneal bleeding, hemopericardium, pulmonary (alveolar) hemorrhage and spinal-epidural hematoma. Fatal bleedings have been reported rarely.
Body As A Whole: Acute and/or severe decreases in platelet counts which may be associated with chills, low-grade fever or bleeding complications (see previously mentioned).
Hypersensitivity: Severe allergic reactions including anaphylactic reactions. The reported cases have occurred during the first day of tirofiban infusion, during initial treatment and during re-administration of tirofiban. Some cases have been associated with severe thrombocytopenia (platelet counts <10,000 mm³).
Laboratory Test Findings: The most frequently observed laboratory adverse events in patients receiving Aggrastat concomitantly with heparin were related to bleeding. Decreases in hemoglobin and hematocrit, and platelet count were observed. Increases in the presence of urine and fecal occult blood were also observed.