Black Box Warning

WARNING: LIFE-THREATENING HEMATOLOGIC ADVERSE REACTIONS. Ticlopidine can cause life-threatening hematologic adverse reactions, including neutropenia/agranulocytosis, thrombotic thrombocytopenic purpura (TTP), and aplastic anemia. Neutropenia/agranulocytosis typically occurs within the first 3 months, and TTP usually develops within the first few weeks of therapy. Aplastic anemia may occur within the first 3 months. Monitor patients for hematologic adverse reactions and obtain complete blood counts with white blood cell differential and platelet counts every 2 weeks for the first 3 months of therapy. Discontinue ticlopidine immediately if any hematologic abnormality is identified.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Ticlopidine.

Other warnings & precautions

Life-threatening hematologic reactions (neutropenia/agranulocytosis, TTP, and aplastic anemia) can occur, especially during the first 3 months of therapy - see boxed warning.
Complete blood counts with white cell differential and platelet estimates are mandatory every 2 weeks from initiation through the third month, and whenever symptoms suggest infection or bleeding.
Discontinue immediately and permanently if the neutrophil count falls below 1,200/mm3, if platelets fall, or if there is any evidence of TTP or aplastic anemia.
Patients must be told to report fever, chills, sore throat, mouth ulcers, unusual or prolonged bleeding or bruising, pallor, jaundice, dark urine, light-colored stools, or neurologic symptoms at once.
Contraindicated in patients with hematopoietic disorders (neutropenia, thrombocytopenia, or a prior history of TTP or aplastic anemia), active pathological bleeding such as peptic ulcer or intracranial hemorrhage, hemostatic disorders, severe hepatic impairment, or known hypersensitivity to the drug.
Ticlopidine prolongs bleeding time; it should be stopped about 10 to 14 days before elective surgery unless antiplatelet effect is specifically desired.
Elevations in serum cholesterol and triglycerides (total cholesterol rises 8-10% within the first month) occur and persist during therapy.
Use caution in patients at increased risk of bleeding from trauma, surgery, or other pathological conditions, and in those with renal or hepatic impairment.

Other warnings & precautions

Life-threatening hematologic reactions (neutropenia/agranulocytosis, TTP, and aplastic anemia) can occur, especially during the first 3 months of therapy - see boxed warning.

Complete blood counts with white cell differential and platelet estimates are mandatory every 2 weeks from initiation through the third month, and whenever symptoms suggest infection or bleeding.

Discontinue immediately and permanently if the neutrophil count falls below 1,200/mm3, if platelets fall, or if there is any evidence of TTP or aplastic anemia.

Patients must be told to report fever, chills, sore throat, mouth ulcers, unusual or prolonged bleeding or bruising, pallor, jaundice, dark urine, light-colored stools, or neurologic symptoms at once.

Contraindicated in patients with hematopoietic disorders (neutropenia, thrombocytopenia, or a prior history of TTP or aplastic anemia), active pathological bleeding such as peptic ulcer or intracranial hemorrhage, hemostatic disorders, severe hepatic impairment, or known hypersensitivity to the drug.

Ticlopidine prolongs bleeding time; it should be stopped about 10 to 14 days before elective surgery unless antiplatelet effect is specifically desired.

Elevations in serum cholesterol and triglycerides (total cholesterol rises 8-10% within the first month) occur and persist during therapy.

Use caution in patients at increased risk of bleeding from trauma, surgery, or other pathological conditions, and in those with renal or hepatic impairment.

Ticlopidine Black Box Warning

Black Box Warning

Other warnings & precautions

Ticlopidine Black Box Warning

Black Box Warning

Other warnings & precautions