Enoxaparin STADA Adverse Reactions

Enoxaparin has been evaluated in more than 15,000 patients who received enoxaparin in clinical trials. These included 1,776 for prophylaxis of deep vein thrombosis following orthopedic or abdominal surgery in patients at risk for thromboembolic complications, 1,169 for prophylaxis of deep vein thrombosis in acutely ill medical patients with severely restricted mobility, 559 for treatment of deep vein thrombosis with or without pulmonary embolism, 1,578 for treatment of unstable angina and non-Q-wave myocardial infarction and 10,176 for treatment of acute ST-elevation myocardial infarction. Enoxaparin sodium regimen administered during these clinical trials varies depending on indications. The enoxaparin sodium dose was 40 mg SC once daily for prophylaxis of deep vein thrombosis following surgery or in acutely ill medical patients with severely restricted mobility. In treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE), patients receiving enoxaparin were treated with either a 1 mg/kg SC dose every 12 hours or a 1.5 mg/kg SC dose once a day. In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 1 mg/kg SC every 12 hours and in the clinical study for treatment of acute ST-segment elevation myocardial infarction enoxaparin sodium regimen were a 30 mg IV bolus followed by 1 mg/kg SC every 12 hours.
The adverse reactions observed in these clinical studies and reported in post-marketing experience are detailed as follows.
Frequencies are defined as follows: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); and very rare (<1/10 ,000). Or not known (cannot be estimated from available data). Post-marketing adverse reactions are designated with a frequency "not known".
Haemorrhages: In clinical studies, haemorrhages were the most commonly reported reaction. These included major haemorrhages, reported at most in 4.2% of the patients (surgical patients). Some of these cases have been fatal. As with other anticoagulants, haemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed, invasive procedures or the concomitant use of medications affecting haemostasis (see Precautions and Interactions). (See Table 5.)

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Thrombocytopenia and thrombocytosis: See Table 6.

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Other clinically relevant adverse reactions: These reactions are presented as follows, whatever the indications, by system organ class, frequency grouping and decreasing order of seriousness. (See Table 7.)

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Post marketing experience: The following adverse reactions have been identified during post-approval use of enoxaparin. The adverse reactions are derived from spontaneous reports and therefore, the frequency is "not known" (cannot be estimated from the available data).
Immune System Disorders: Anaphylactic/anaphylactoid reaction including shock.
Nervous System Disorders: Headache.
Vascular Disorders: Cases of spinal haematoma (or neuraxial haematoma) have been reported with the concurrent use of enoxaparin as well as spinal/epidural anesthesia or spinal puncture. These reactions have resulted in varying degrees of neurologic injuries including long-term or permanent paralysis (see Spinal/epidural anesthesia in patients given prevent treatment with LMWH under Warnings).
Blood and Lymphatic System Disorders: Haemorrhagic anemia; Cases of immune-allergic thrombocytopenia with thrombosis; in some of them thrombosis was complicated by organ infarction or limb ischaemia (see Precautions for use: Laboratory tests: Platelet monitoring under Precautions); Eosinophilia.
Skin and subcutaneous disorders: Cutaneous vasculitis, skin necrosis usually occurring at the injection site (these phenomena have been usually preceded by purpura or erythematous plaques, infiltrated and painful). Treatment with enoxaparin sodium must be discontinued; Injection site nodules (inflammatory nodules, which were not cystic enclosure of enoxaparin). They resolve after a few days and should not cause treatment discontinuation; Alopecia.
Hepatobiliary disorders: Hepatocellular liver injury; Cholestatic liver injury.
Musculoskeletal and connective tissue disorders: Osteoporosis following long-term therapy (greater than 3 months).