Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions reported in at least 3% and at a greater rate than placebo for subjects treated with LOVAZA based on pooled data across 23 clinical trials are listed in Table 1.
Table 1: Adverse Reactions Occurring at Incidence
> 3% and Greater than Placebo in Clinical Trials of LOVAZA
|Adverse Reactiona||LOVAZA (N = 655)||Placebo (N = 370)|
|Taste perversion||27||4||1||< 1|
|a Trials included subjects with HTG and severe HTG.|
Additional adverse reactions from clinical trials are listed below:
Digestive System: Constipation, gastrointestinal disorder and vomiting.
Metabolic and Nutritional Disorders: Increased ALT and increased AST.
Skin: Pruritus and rash.
In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of LOVAZA. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.
The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.
Read the Lovaza (omega-3-acid ethyl esters) Side Effects Center for a complete guide to possible side effects
Anticoagulants Or Other Drugs Affecting Coagulation
Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of LOVAZA and concomitant anticoagulants. Patients receiving treatment with LOVAZA and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Drug Abuse And Dependence
LOVAZA does not have any known drug abuse or withdrawal effects.
Read the Lovaza Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/2/2014
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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