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Drug Profile

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Generic drug name: ticlopidine (tye KLOE pi deen)
Brand name(s): TICLID
GENERIC: available FAMILIES: Adenosine Diphosphate Blockers, Blood-clotting Inhibitors
Find the drug label by searching at DailyMed.

Alternative Treatment [top]

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

TICLID can cause life-threatening hematological (blood) adverse reactions, including neutropenia/agranulocytosis, thrombotic throbocytopenia purpura (TTP) and aplastic anemia.

Neutropenia/Agranlocytosis: Among 2048 patients in clinical trials in stroke patients, there were 50 cases (2.4%) of neutropenia (less than 1200 neutrophils/mm3), and the neutrophil count was below 450/mm3 in 17 of these patients (0.8% of the total population).

TTP: One case of thrombotic thrombocytopenic purpura was reported during clinical trials in some patients. Based on postmarketing data, US physicians reported about 100 cases between 1992 and 1997. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine associated TTP may be as high as one case in 2000 to 4000 patients exposed.

Aplastic Anemia: Aplastic anemia was not seen during clinical trials in stroke patients, but US physicians reported about 50 cases between 1992 and 1998. Based on an estimated patient exposure of 2 million to 4 million, and assuming an event reporting rate of 10% (the true rate is not known), the incidence of ticlopidine associated aplastic anemia may be as high as one case in every 4000 to 8000 patients exposed.

Monitoring of Clinical Hematologic Status: Severe hematological adverse reactions may occur within a few days of the start of therapy. The incidence of TTP peaks after about 3 to 4 weeks of therapy and neutropenia peaks at approximately 4 to 6 weeks. The incidence of aplastic anemia peaks after about 4 to 8 weeks of therapy. The incidence of the hematologic adverse reactions declines thereafter. Only a few cases of neutropenia, TTP, or aplastic anemia have arisen after more than three months of therapy.

Hematological adverse reactions cannot be reliably predicted by any identified demographic or clinical characteristics. During the first 3 months of treatment, patients receiving TICLID must, therefore, be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, TICLID should be immediately discontinued.

Facts About This Drug [top]

Ticlopidine is approved by the Food and Drug Administration (FDA) to prevent stroke in people who have already had strokes or have signs of developing a stroke and who are unable to take aspirin or have not responded to aspirin therapy. It is also Approved for use to prevent clot formation after a procedure in which a thin tube called a stent is implanted to keep narrowed heart arteries open. 

Ticlopidine prolongs bleeding time so blood clots are less apt to form. The dose of ticlopidine...

Ticlopidine is approved by the Food and Drug Administration (FDA) to prevent stroke in people who have already had strokes or have signs of developing a stroke and who are unable to take aspirin or have not responded to aspirin therapy. It is also Approved for use to prevent clot formation after a procedure in which a thin tube called a stent is implanted to keep narrowed heart arteries open. 

Ticlopidine prolongs bleeding time so blood clots are less apt to form. The dose of ticlopidine is adjusted according to a test that measures bleeding time. Although somewhat more effective than aspirin in preventing strokes, ticlopidine causes significantly more adverse effects than aspirin, including life-threatening blood disorders. It lowers the white blood cell count, increasing risk of infections, and can injure the ability of bone marrow to make red blood cells. Ticlopidine also increases cholesterol about 10%. It should only be used by people who are allergic to aspirin. Ticlopidine should not be used by people who have had bleeding ulcers or liver disease. Anyone with kidney problems may need lower doses of ticlopidine.

Over half the individuals who take ticlopidine have had gastrointestinal adverse effects.[1] Older people are even more likely to experience adverse effects, especially gastrointestinal effects, such as nausea and diarrhea. Severe blood disorders have been reported, most frequently in women over 75 years of age.[2] 

Worldwide, through 1994, a total of 645 cases of serious blood disorders had been associated with the use of ticlopidine. Of these 645 cases, 102 (16%) resulted in death. Since ticlopidine was first marketed in late 1991 through March 1995, the FDA had received 209 reports associating various types of blood disorders with this drug. Of 188 people for whom complete information was available, 36 (19%) had died. In reports to the FDA, onset of the blood disorder occurred about 30 to 45 days after starting ticlopidine. In some of the reports, people had been taking other drugs that can cause blood disorders, but most had no known causes other than ticlopidine. The bone marrow’s ability to make blood cells returned to normal in most people after they stopped the drug.[2]

last reviewed June 30, 2021