Omacor Special Precautions

Omacor should be used with caution in patients with known sensitivity or allergy to fish.
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 effects of Omacor and concomitant anticoagulants. Patients receiving treatment with Omacor and an anticoagulant or other drug affecting coagulation (eg, acetylsalicylic acid, warfarin and coumarin) should be monitored periodically, and the dosage of anticoagulant therapy adjusted if necessary.
It is recommended that routine monitoring of the entire lipid profile is undertaken. As a possible rise in LDL-C has been shown in some studies with intake of Omacor 4 g/day (see Pharmacology: Pharmacodynamics: CLINICAL TRIALS under Actions), LDL-C should therefore be monitored on a regular basis, especially in patients with type IV and V dyslipidaemia.
Omacor is not recommended as monotherapy in Type IIb dyslipidaemia. Statins are to be used as first line treatment with Omacor indicated as add-on therapy when control of the triglyceride levels is required.
Hepatic Impairment: Regular monitoring of hepatic function (especially ALT - see ADVERSE REACTIONS, and AST) is required in patients with hepatic impairment, in particular with the higher dosage of 4 g per day.
Effects on Fertility: No adverse effects on fertility were observed in a rat fertility study at oral doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis).
Carcinogenicity: There was no evidence of a carcinogenic effect of Omacor from the carcinogenicity studies in rats and mice at oral doses of up to 2,000 mg/kg/day (35 times the human dose of 4 g/day on a mg/kg basis).
Genotoxicity: There was no clear evidence of a genotoxic effect of Omacor from the genotoxicity studies conducted (Ames test in Salmonella typhimurium, gene mutation at the HGPRT locus in Chinese hamster V79 cells, chromosome aberration study in cultured human lymphocytes and in vivo mouse micronucleus test).
Use in Pregnancy: Category B1: 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 components in human milk. Because many drugs are excreted in human milk, caution should be exercised when Omacor is administered to a woman who is breastfeeding.
Use in Children: In the absence of efficacy and safety data, the use of this medication in children is not recommended.