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| __NOTOC__
| | #REDIRECT [[Clopidogrel#Adverse Reactions]] |
| {{Clopidogrel}}
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| {{CMG}}; {{AE}} {{JH}}
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| ==Adverse Reactions==
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| The following serious adverse reactions are discussed below and elsewhere in the labeling:
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| Bleeding [see Warnings and Precautions (5.2)]
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| Thrombotic thrombocytopenic purpura [see Warnings and Precautions (5.5)]
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| ====6.1 Clinical Studies Experience====
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| Because clinical trials are conducted under widely varying conditions and durations of follow up, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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| Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for 1 year or more. The clinically important adverse reactions observed in trials comparing Plavix plus [[aspirin]] to placebo plus aspirin and trials comparing Plavix alone to [[aspirin]] alone are discussed below.
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| ======Bleeding======
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| '''CURE'''
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| In CURE, Plavix use with aspirin was associated with an increase in major bleeding (primarily gastrointestinal and at puncture sites) compared to placebo with aspirin (see Table 1). The incidence of [[intracranial hemorrhage]] (0.1%) and fatal bleeding (0.2%) were the same in both groups. Other bleeding events that were reported more frequently in the clopidogrel group were [[epistaxis]], [[hematuria]], and [[bruise]].
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| The overall incidence of bleeding is described in Table 1.
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| {|
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| | [[File:Plav02.png|600px|thumb]]
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| |}
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| Ninety-two percent (92%) of the patients in the CURE study received heparin or [[low molecular weight heparin]] ([[LMWH]]), and the rate of bleeding in these patients was similar to the overall results.
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| '''COMMIT'''
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| In COMMIT, similar rates of major bleeding were observed in the Plavix and placebo groups, both of which also received aspirin (see Table 2).
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| {|
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| | [[File:Plav03.png|600px|thumb]]
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| |}
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| '''CAPRIE (Plavix vs. Aspirin)'''
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| In CAPRIE, gastrointestinal hemorrhage occurred at a rate of 2.0% in those taking Plavix vs. 2.7% in those taking aspirin; bleeding requiring hospitalization occurred in 0.7% and 1.1%, respectively. The incidence of intracranial hemorrhage was 0.4% for Plavix compared to 0.5% for aspirin.
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| Other bleeding events that were reported more frequently in the Plavix group were [[epistaxis]] and [[hematoma]].
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| ======Other Adverse Events======
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| In CURE and CHARISMA, which compared Plavix plus aspirin to aspirin alone, there was no difference in the rate of adverse events (other than bleeding) between Plavix and placebo.
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| In CAPRIE, which compared Plavix to aspirin, [[pruritus]] was more frequently reported in those taking Plavix. No other difference in the rate of adverse events (other than bleeding) was reported.
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| ====6.2 Postmarketing Experience====
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| The following adverse reactions have been identified during post-approval use of Plavix. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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| <u>'''Blood and lymphatic system disorders'''</u>: [[Agranulocytosis]], [[aplastic anemia]]/[[pancytopenia]], [[thrombotic thrombocytopenic purpura]] ([[TTP]]), acquired [[hemophilia A]]
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| <u>'''Eye disorders'''</u>: Eye (conjunctival, ocular, retinal) bleeding
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| <u>'''Gastrointestinal disorders'''</u>: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, [[colitis]] (including ulcerative or [[lymphocytic colitis]]), [[pancreatitis]], [[stomatitis]], gastric/duodenal ulcer, [[diarrhea]]
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| <u>'''General disorders and administration site condition'''</u>: [[Fever]], hemorrhage of operative wound
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| <u>'''Hepato-biliary disorders'''</u>: [[Acute liver failure]], [[hepatitis]] (non-infectious), [[abnormal liver function test]]
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| <u>'''Immune system disorders'''</u>: [[Hypersensitivity reactions]], [[anaphylactoid reactions]], [[serum sickness]]
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| <u>'''Musculoskeletal, connective tissue and bone disorders'''</u>: Musculoskeletal bleeding, [[myalgia]], [[arthralgia]], [[arthritis]]
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| <u>'''Nervous system disorders'''</u>: [[Taste disorders]], fatal intracranial bleeding, [[headache]]
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| <u>'''Psychiatric disorders'''</u>: [[Confusion]], [[hallucinations]]
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| <u>'''Respiratory, thoracic and mediastinal disorders'''</u>: [[Bronchospasm]], interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
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| <u>'''Renal and urinary disorders'''</u>: Increased creatinine levels
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| <u>'''Skin and subcutaneous tissue disorders'''</u>: Maculopapular, erythematous or exfoliative [[rash]], [[urticaria]], bullous dermatitis, eczema, toxic epidermal necrolysis, [[Stevens-Johnson syndrome]], [[angioedema]], drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), [[erythema multiforme]], skin bleeding, [[lichen planus]], generalized pruritus
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| <u>'''Vascular disorders'''</u>: Vasculitis, hypotension<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = PLAVIX (CLOPIDOGREL BISULFATE) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB/SANOFI PHARMACEUTICALS PARTNERSHIP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=01b14603-8f29-4fa3-8d7e-9d523f802e0b | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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