Clexane Adverse Reactions

Clinical Trial Data: The following information relates to adverse events observed in controlled clinical trials with patients given enoxaparin sodium prophylactically or for the treatment of deep vein thrombosis (n=1170) or with patients given enoxaparin sodium for the treatment of unstable angina or non-Q-wave myocardial infarction, administered concurrently with aspirin (n=1578).
Haematological: Common: Haemorrhage. During enoxaparin therapy, bleeding may occur in the presence of associated risk factors eg, organic lesions liable to bleed, invasive procedures or the use of medications affecting haemostasis (see Interactions). The origin of the bleeding should be investigated and appropriate treatment instituted.
Blood Disorders: Uncommon: Thrombocytopaenia. Mild, transient, asymptomatic thrombocytopaenia has been reported during the 1st days of therapy.
Hepatic: Uncommon: Asymptomatic and reversible increase in liver enzymes (eg, transaminases) levels have been reported (Note: Liver enzymes were not assessed in the unstable angina population).
Post-Marketing Data: The following information relates to events observed following the marketing of enoxaparin sodium. Voluntary reports of adverse events that have been received since market introduction (without causal relationship) that are not listed previously are cited as follows:
Haematological: Very Rare: There have been rare reports of intraspinal haematomas with the concurrent use of enoxaparin and spine/epidural anaesthesia and postoperative indwelling catheters. These events have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see Precautions).
Rare cases of immunoallergic thrombocytopaenia with or without thrombosis have been reported (see Precautions).
Asymptomatic and reversible increases in platelet counts levels have been reported.
Hypersensitivity and Skin: Injection Site: Very Rare: Pain, haematoma and mild local irritation may follow the SC injection of enoxaparin.
Hard inflammatory nodules, which are not cystic enclosures of enoxaparin, have been observed at the injection site. They resolve after a few days and should not cause treatment discontinuation.
Cases of skin necrosis at the injection site have been reported with both unfractionated and low-molecular weight heparins. These phenomena are usually preceded by purpura or erythematous plaques, infiltrated and painful. Treatment must be discontinued immediately.
Systemic Allergic Reactions: Very Rare: Cutaneous (bullous) or systemic allergic reactions (eg, pruritus, rash and urticaria) including anaphylactoid reaction, may occur. In some cases, discontinuation of the treatment may be necessary.