Lovenox Adverse Reactions

The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed as follows.
Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1 000, <1/100), rare (≥1/10 000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data). Frequency for undesirable effects reported during the post-marketing period is defined as "not known" (cannot be estimated from the available data).
Clinical trials experience: Enoxaparin was evaluated in more than 15,000 patients in clinical trials.
The number of patients, indication and dosage regimen are presented in detail in the following table. (See Table 2.)


Click on icon to see table/diagram/image


Hemorrhage: In clinical studies, hemorrhages were the most commonly reported reaction. These included major hemorrhages, reported in 4.2 % of patients (surgical patients). Some of these cases were fatal.
Bleeding complications were considered major in the following cases: If the hemorrhage caused a significant clinical event; If accompanied by a hemoglobin decrease of ≥ 2 g/dl or transfusion of 2 or more units of blood products; Retroperitoneal and intracranial hemorrhages were always considered major.
As with other anticoagulants, hemorrhage may occur in the presence of associated risk factors such as: organic lesions liable to bleed; invasive procedures or concomitant use of medications affecting hemostasis. (See Table 3.)


Click on icon to see table/diagram/image


Thrombocytopenia and Thrombocytosis: (See Table 4.)


Click on icon to see table/diagram/image


Other adverse reactions observed in clinical studies: These reactions are presented below, irrespective of the indication, by system organ class, frequency grouping and decreasing order of seriousness. (See Table 5.)


Click on icon to see table/diagram/image


Post Marketing Experience: The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily, the frequency is “not known” (cannot be estimated from the available data).
Immune System Disorders: Cutaneous or systemic allergic effects (anaphylactic or anaphylactoid reactions, including shock), which, in certain cases, may lead to treatment discontinuation.
Nervous System Disorders: Headache.
Vascular Disorders: Hemorrhagic episodes that mainly occur in the following context: associated risk factors: organic lesions likely to bleed and certain drug combinations (see Interactions), age, renal failure, low body weight; failure to comply with therapeutic recommendations, particularly duration of treatment and dose adjustment based on body weight.
Rare cases of spinal hematoma have been reported with low molecular weight heparins (LMWH) in patients receiving spinal anesthesia, analgesia or epidural anesthesia. These hematomas have resulted in more or less serious neurologic injury, including long-term or permanent paralysis.
Blood and Lymphatic System Disorders: Thrombocytopenia has been reported.
There are two types: Type I, i.e. the most common cases, usually moderate (more than 100
000/mm3), of early onset (before the fifth day) which do not require treatment discontinuation; Type II, i.e. rare, serious immunoallergic thrombocytopenia (HIT). The incidence remains poorly evaluated.
Asymptomatic and reversible elevation of the platelet count.
Hemorrhagic anemia.
Hypereosinophilia, occurring in isolated cases or along with skin reactions, resolving on treatment discontinuation.
Skin and Subcutaneous Disorders: Vasculitis due to skin hypersensitivity.
Skin necrosis observed in most cases at the injection site. These reactions may be preceded by purpura or by infiltrated and painful erythematous plaques. Treatment must be discontinued immediately in these cases.
Alopecia.
Hepatobilary Disorders: Hepatocellular or cholestatic liver injury.
Musculoskeletal and Connective Tissue Disorders: Osteoporosis following long-term therapy.