heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml Adverse Reactions

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Hemorrhage [see Warnings and Precautions (5.2)]
Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis [see Warnings and Precautions (5.3)]
Thrombocytopenia [see Warnings and Precautions (5.4)]
Heparin Resistance [see Warnings and Precautions (5.6)]
Hypersensitivity [see Warnings and Precautions (5.7)]
Hyperkalemia [see Warnings and Precautions (5.8)]
Elevations of Serum Aminotransferases [see Warnings and Precautions (5.9)]

6.1 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of heparin sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Hemorrhage - Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and Precautions (5.2)]. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug [see Overdosage (10)]. Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect:
a.
Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases.during anticoagulant therapy.
b.
Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
c.
Retroperitoneal hemorrhage.
Vascular Disorders – Contusion, vasospastic reactions (including episodes of painful, ischemic, and cyanosed limbs).
HIT and HITT, including delayed onset cases, and Thrombocytopenia - [see Warnings and Precautions (5.3, 5.4)]
Histamine-like reactions – Such reactions have been observed at the site of injections. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting.
Hypersensitivity – Generalized hypersensitivity reactions have been reported with chills, fever, and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar site of the feet, may occur [see Warnings and Precautions (5.7)].
Musculoskeletal, Connective Tissue and Bone Disorders – Osteoporosis with long-term administration of heparin.
Metabolism and Nutrition Disorders – Hyperkalemia.
General Disorders and Administration Site Conditions – Erythema, mild pain, ulceration.
Elevations of Serum Aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin.
Others – Osteoporosis following long-term administration of high-doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.

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Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Hemorrhage [see Warnings and Precautions (5.2)]
Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis [see Warnings and Precautions (5.3)]
Thrombocytopenia [see Warnings and Precautions (5.4)]
Heparin Resistance [see Warnings and Precautions (5.6)]
Hypersensitivity [see Warnings and Precautions (5.7)]
Hyperkalemia [see Warnings and Precautions (5.8)]
Elevations of Serum Aminotransferases [see Warnings and Precautions (5.9)]

6.1 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of heparin sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Hemorrhage - Hemorrhage is the chief complication that may result from heparin therapy [see Warnings and Precautions (5.2)]. An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug [see Overdosage (10)]. Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect:
a.
Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred with heparin therapy, including fatal cases.during anticoagulant therapy.
b.
Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy.
c.
Retroperitoneal hemorrhage.
Vascular Disorders – Contusion, vasospastic reactions (including episodes of painful, ischemic, and cyanosed limbs).
HIT and HITT, including delayed onset cases, and Thrombocytopenia - [see Warnings and Precautions (5.3, 5.4)]
Histamine-like reactions – Such reactions have been observed at the site of injections. Necrosis of the skin has been reported at the site of subcutaneous injection of heparin, occasionally requiring skin grafting.
Hypersensitivity – Generalized hypersensitivity reactions have been reported with chills, fever, and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar site of the feet, may occur [see Warnings and Precautions (5.7)].
Musculoskeletal, Connective Tissue and Bone Disorders – Osteoporosis with long-term administration of heparin.
Metabolism and Nutrition Disorders – Hyperkalemia.
General Disorders and Administration Site Conditions – Erythema, mild pain, ulceration.
Elevations of Serum Aminotransferases – Significant elevations of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels have occurred in patients who have received heparin.
Others – Osteoporosis following long-term administration of high-doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.
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