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Plavix: a blood thinner
Some side effects of Plavix may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Get emergency medical help if you have any of these signs of an allergic reaction while taking clopidogrel (the active ingredient contained in Plavix) hives; difficulty breathing; swelling of , lips, tongue, or throat.
Stop using clopidogrel and call your doctor at once if you have any of these serious side effects:
· nosebleed or other bleeding that will not stop;
· bloody or tarry stools, blood in your urine;
· coughing up blood or that looks like coffee grounds;
· chest pain or heavy feeling, pain spreading to the arm or shoulder, , sweating, general ill feeling;
· sudden numbness or weakness, especially on one side of the body;
· sudden headache, confusion, problems with vision, speech, or balance;
· pale , weakness, fever, or jaundice (yellowing of the skin or eyes); or
· easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under .
Less serious side effects may include itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Clopidogrel has been evaluated for safety in more than 17,500 patients, including over 9,000 patients treated for 1 year or more. The overall tolerability of clopidogrel (the active ingredient contained in Plavix) in CAPRIE was similar to that of aspirin regardless of age, gender and race, with an approximately equal incidence (13%) of patients withdrawing from treatment because of adverse reactions.
General complaints among at least 2.5% of treated patients in controlled trials have included chest pain, influenza-like syndrome, general body pain, or fatigue. A causal relationship has not been clearly demonstrated.
Hematologic side effects appear to be less commonly associated with clopidogrel (the active ingredient contained in Plavix) when compared with ticlopidine. Hemorrhage has been the most commonly reported and potentially serious, or fatal, side effect. Safety evaluation data from large clinical trials have shown that gastrointestinal hemorrhage occurred in 2.0% of patients and required hospitalization in 0.7%. In patients receiving aspirin the corresponding rates were 2.7% and 1.1%, respectively. The incidence of intracranial hemorrhage associated with the use of clopidogrel and aspirin was 0.4% and 0.5%, respectively. Purpura and epistaxis have been reported in 5.3% and 2.9% of patients, respectively. Similar incidences were observed among patients treated with aspirin in comparative trials.
Results from the CURE study (Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events) showed the use of clopidogrel with aspirin was associated with an increase in bleeding compared to placebo with aspirin. There was an excess in major bleeding in patients receiving clopidogrel plus aspirin compared with placebo plus aspirin (primarily gastrointestinal and at puncture sites). The incidence of fatal bleeding (0.2%) and intracranial hemorrhage (0.1%) was the same in both groups.
Rare incidences of granulocytopenia, leukemia, leukopenia, and a decrease in neutrophils have also been reported.
Thrombotic thrombocytopenic purpura (TTP), not noted during clinical trials, has been reported. A potentially life threatening event, the incidence of TTP usually occurred within 2 weeks of initiation of clopidogrel. Plasma exchange resulted in resolution of symptoms and laboratory abnormalities.
Agranulocytosis, aplastic anemia/pancytopenia, retroperitoneal hematoma, and conjunctival, ocular and retinal bleeding have been reported during postmarketing experience.
Severe neutropenia (less than 450 neutrophils/mcL) has occurred in approximately 4/10,000 patients. Although the risk of myelosuppression appears to be quite low, it is recommended in cases of fever or other signs of infection that possible neutropenia be evaluated. Gastrointestinal hemorrhage has been observed in approximately 1.0% to 2.5% of patients. Hemarthrosis, hematuria, hemoptysis, retroperitoneal hemorrhage, operative wound hemorrhage, ocular hemorrhage, pulmonary hemorrhage, allergic purpura, menorrhagia, thrombocytopenia, agranulocytosis, granulocytopenia, leukemia, leukopenia, neutropenia, aplastic anemia, and hypochromic anemia have occurred in less than 1% of patients. These adverse events were observed at similar rates among patients treated with aspirin in controlled trials.
Subarachnoid hemorrhage has been reported in a patient receiving clopidogrel and aspirin following lumbar puncture. Several attempts were required in order to reach the intrathecal space.
Rare GI adverse events included perforated gastric ulcer, hemorrhagic gastritis, and upper GI hemorrhage. Similar incidences were observed among patients treated with aspirin in comparative trials.
A randomized trial studied patients in Hong Kong who took aspirin to prevent vascular diseases. The patients were randomized to clopidogrel (the active ingredient contained in Plavix) 75 mg daily plus placebo twice daily or aspirin 80 mg daily plus esomeprazole 20 mg twice daily for 12 months. The study found that recurrent ulcer bleeding occurred in 8.1% of the clopidogrel/placebo group compared to 0.6% of the aspirin/esomeprazole group. There were no differences in rates of lower gastrointestinal bleeding (4.3% vs. 4.4%) or recurrent ischemic events (5.6% vs. 6.9%).
Gastrointestinal (GI) discomfort has occurred in 27.1% of patients (compared with 29.8% of patients who were treated with aspirin in comparative trials). Other GI side effects have included in 4.5%, dyspepsia in 5.2%, nausea in 3.4%, and abdominal pain in 5.6% of patients. Colitis, pancreatitis, and stomatitis have also been reported during postmarketing experience. Rarely, gastritis and constipation have been reported.
The development of ulcers have also been associated with the use of this drug. Results from a randomized trial in Hong Kong showed that patients taking clopidogrel may experience more than 12 times as many ulcers as patients who take aspirin plus esomeprazole.
Hypersensitivity reactions have been reported in less than 1% of patients. In addition, hypersensitivity reactions as well as anaphylactoid reactions and serum sickness have been reported in postmarketing experience.
Clopidogrel-induced hypersensitivity syndrome has been associated with febrile pancytopenia, elevated liver enzymes, tachycardia, nausea, , rash, pruritus, fever, and neutropenia. In at least one case, hypersensitivity syndrome resolved with dechallenge and recurred upon rechallenge.
Cardiovascular side effects have included chest pain (8.3%), edema (4.1%), and hypertension (4.3%) in treated patients during controlled trials (compared with 8.3%, 4.5% and 5.1%, respectively, in patients who were given aspirin). Cardiovascular adverse events that have occurred in 1.0% to 2.5% of patients included syncope, palpitations, atrial fibrillation, and heart failure. Generalized edema has been reported in less than 1% of treated patients. A relationship between these adverse events and clopidogrel (the active ingredient contained in Plavix) administration has not been clearly defined. Similar rates were observed among patients treated with aspirin in controlled trials.
Rarely, heart failure has been associated with the use of clopidogrel. Vasculitis, angioedema, and hypotension have also been reported during postmarketing experience.
Nervous system side effects have included headache (7.6%) and dizziness (6.2%). Similar incidences were observed among patients treated with aspirin in comparative trials. Rarely, hypoesthesia, neuralgia, paresthesia, and vertigo like symptoms have been reported. Confusion and hallucinations were also reported during postmarketing experience.
Musculoskeletal side effects including arthralgias and back pain have been reported in approximately 6% of patients. A similar incidence was observed in patients treated with aspirin in comparative trials. Myalgia has been reported during postmarketing experience.
Psychiatric side effects including depression (3.6%), anxiety, and insomnia have been reported. The incidence of depression among patients treated with aspirin in comparative trials was 3.9%. The baseline incidence among patients prior to drug therapy was not reported. Less than 0.1% of patients discontinued therapy due to depression. Anxiety and insomnia were observed at similar rates among patients treated with aspirin in controlled trials.
Respiratory tract side effects have included upper respiratory tract infection (8.7%), dyspnea (4.5%), rhinitis (4.2%), bronchitis (3.7%), and cough (3.1%). Less than 0.1% of patients discontinued therapy due to these symptoms. Bronchospasm and interstitial pneumonitis have been reported in postmarketing experience.
Dermatologic adverse events that occurred in 1.0% to 2.5% of patients included eczema and skin ulceration. Rare cases of serious skin eruptions, such as bullous eruptions, erythematous or maculopapular rashes, or urticaria have occurred in less than 1.0% of patients. These adverse events were observed at similar rates among patients treated with aspirin in controlled trials.
Two case reports of patients developing maculopapular pruritic rashes following administration of clopidogrel (the active ingredient contained in Plavix) have been reported. The rash recurred in both patients after switching to ticlopidine. In one patient, rechallenge resulted in recurrence of the rash. These two cases illustrate the possibility of cross-sensitivity between thienopyridines.
Dermatologic side effects have manifested primarily as hypersensitivity reactions. Rash and pruritus have occurred in 4.2% and 3.3% of patients, respectively. However, the incidence of rash and all skin disorders has been as high as 16% (0.7% serious). The incidence of patient withdrawal due to skin and appendage adverse reactions has been 1.5%.
Erythema multiforme, lichen planus, Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported during postmarketing experience. At least one case of suberythrodermic pustular psoriasis has been reported following administration of clopidogrel.
Hepatic side effects including elevated hepatic enzymes have occurred in 1.0% to 2.5% of patients. Hyperbilirubinemia, hepatitis, and fatty liver have been reported in fewer than 1% of patients. A relationship between these adverse events and clopidogrel (the active ingredient contained in Plavix) is not clear and the incidences were similar among patients treated with aspirin in controlled trials. Abnormal liver function tests, hepatitis (non-infectious), and acute liver failure have been reported in postmarketing experience.
A patient experienced elevated liver enzymes and fever within days of initiating treatment with clopidogrel. Following discontinuation of clopidogrel, liver enzymes returned to normal and fever disappeared. Upon rechallenge, these signs and symptoms returned. However, the patient was able to tolerate treatment with ticlopidine without adverse effects.
Metabolic side effects have occurred at an incidence of 1.0% to 2.5%, however, their relationship to clopidogrel (the active ingredient contained in Plavix) has not been clearly defined. Adverse effects included hyperuricemia, gout, and increased plasma concentrations of nonprotein nitrogen.
Genitourinary side effects have been extremely rare. Cystitis has been reported among 1.0% to 2.5% of patients in controlled trials, although the relationship to drug therapy is questionable. Cystitis occurred at similar rates among patients treated with aspirin in controlled trials. Glomerulopathy and elevated creatinine levels have also been reported during postmarketing experience.
Ocular side effects have been extremely rare. Cataracts or conjunctivitis have been reported in 1.0% to 2.5% of patients, although the relationship to drug therapy has not been established. These adverse events occurred at similar rates in patients treated with aspirin in controlled trials.
Other side effects reported during clinical trials have included accidental injury (7.9%), influenza-like symptoms (7.5%), pain (6.4%), and fatigue (3.3%). The incidence of these effects was similar to that reported with aspirin use. Taste disorders have also been reported during postmarketing experience.
Renal side effects including glomerulonephropathy and increased creatinine levels have been reported during postmarketing experience. In addition, membranous nephropathy has been associated with clopidogrel (the active ingredient contained in Plavix) use.
Immunologic side effects including a possible link between autoimmune acquired hemophilia and clopidogrel (the active ingredient contained in Plavix) has been reported. Systemic inflammatory response syndrome has also been associated with clopidogrel use.
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