NDA 17-037/S-158
Page 19
Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) and Heparin-induced
Thrombocytopenia and Thrombosis (HITT) and Delayed Onset of HIT and HITT
See WARNINGS
. Local Irritation
Local irritation and erythema have been reported with the use of Heparin Lock Flush Solution.
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 side of the feet, may occur.
Thrombocytopenia has been reported to occur in patients receiving heparin,
with a reported incidence
of 0 to 30
%. While often mild and of no obvious clinical significance, such thrombocytopenia can be
accompanied by severe thromboembolic complications
such as skin necrosis, gangrene of the
extremities that may lead to amputation,
myocardial infarction, pulmonary embolism, stroke, and
possibly death. (See
WARNINGS and
PRECAUTIONS.)
Certain episodes of painful, ischemic and cyanosed limbs have in the past
been attributed to allergic
vasospastic reactions. Whether these are in fact identical to the thrombocytopenia-associated
complications remains to be determined.
OVERDOSAGE
Symptoms
Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be
noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.
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