LOVAZA (omega-3 acid ethyl esters)

There are 0 contraindications.

There are 0 severe contraindications.

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Atrial fibrillation
Disease of liver

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Hemorrhage Increased alanine transaminase Increased aspartate transaminase

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysgeusia Dyspepsia Eructation Skin rash

Rare/Very Rare
Abnormal hepatic function tests Constipation Pruritus of skin Urticaria Vomiting

Available data are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes with the use of omega-3-acid ethyl esters in pregnant women. No teratogenic or adverse developmental effects have been observed in animal reproduction studies.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Omega-3 Acids Ethyl Esters	2	Insuff human data; consider maternal benefit	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

Omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have been detected in human milk. Higher levels of omega-3 fatty acids have been observed in the milk of lactating women receiving omega-3 fatty acid supplementation. There are no data on the effects of omega-3 fatty acid ethyl esters on the breast-fed infant or on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Omega-3 Acid Ethyl Esters	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insufficient human data available

Experience in patients >65 years of age is limited. No substantial differences in safety and efficacy were observed between patients >60 years of age and younger patients.