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During treatment with Omacor, there is a fall in thromboxane A2 production. No significant effect has been observed on the other coagulation factors. Some studies with omega-3-acids demonstrated a prolongation of bleeding time, but the bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes.
Clinical studies have not been done to thoroughly examine the combined effect of Omacor and concomitant anticoagulants. Patients receiving treatment with Omacor and an anticoagulant or other drug affecting coagulation (eg, acetylsalicylic acid, warfarin, coumarin) should be monitored periodically (see Interactions).
In some patients, a small but significant increase (within normal values) in aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) was reported, but there are no data indicating an increased risk for patients with hepatic impairment. Alanine aminotransferase and ASAT levels should be monitored in patients with any signs of liver damage (in particular with the high dosage ie, 4 capsules).
Omacor is not indicated for exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). There is only limited experience in secondary endogenous hypertriglyceridaemia (especially uncontrolled diabetes) so the physician should check the patient carefully before prescribing Omacor if the patient suffers from this condition.
Effects on the Ability to Drive or Operate Machinery: Effects on ability to drive and use machines have not been studied. Nevertheless, Omacor is expected to have no or negligible influence on the ability to drive and use machines.
Use in Pregnancy: There are no adequate data from the use of Omacor in pregnant women. The potential risk for humans is unknown. Therefore, Omacor should not be used during pregnancy unless clearly necessary.
Use in Lactation: There are no data on the excretion of Omacor in human milk. Omacor should not be used during lactation.
