Adverse reactions : תופעות לוואי

4.8      Undesirable effects
Undesirable effects observed during the administration of Omegaven:

Investigations:
Rare (≥ 1/10,000, <1/1,000): The infusion of Omegaven can lead to a prolonged bleeding time and an inhibited platelet aggregation. Clinically relevant abnormalities have not been observed.

Gastrointestinal Disorders:
Rare (≥ 1/10,000, <1/1,000): fishy taste

Undesirable effects observed during the administration of fat emulsions: 
Uncommon                 Rare                      Very rare
≥ 1/1,000 to <1/100      ≥ 1/10,000 to <1/1,000    < 1/10,000
Blood and                                                               Thrombocytopenia, lymphatic system                                                        haemolysis, reticulocytosis disorders
Gastrointestinal     Abdominal pain disorders            nausea, vomiting
General disorders    Rise in body and administration   temperature,
site conditions      shivering, chills,
tiredness
Immune system                                                           Anaphylactic reaction disorders
Investigations                                                          Transient increase in liver function test
Metabolism and      Hypertriglyceridaemia nutrition disorders
Nervous system      Headache disorders
Reproductive                                                            Priapism system and breast disorders
Skin and                                                                Rash, urticaria subcutaneous tissue disorders
Vascular disorders                                                      Circulatory effects (e.g. hyper/hypotension)
Trombocytopenia has been reported in association with prolonged treatment with fat emulsions in infants.
Transient increase in liver function tests after prolonged intravenous nutrition with or without fat emulsions have also been noted. The reasons are not clear at present.

Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolisms) and with respect to different previous illnesses with varying rapidity and following different doses, but has been observed mainly with the use of cottonseed oil emulsions.

- Metabolic overload might give the following symptoms:
- hepatomegaly with or without icterus
- a change or reduction of some coagulation parameters (e.g. bleeding time, coagulation time, prothrombin time, platelet count)
- splenomegaly
- anaemia, leucopenia, thrombocytopenia
- bleedings and tendency to bleed
- pathological liver function tests
- fever
- hyperlipidaemia
- headache, stomach pains, fatigue
- hyperglycemia.

Should these side-effects occur or should the triglyceride level during lipid infusion rise above 3 mmol/l, the lipid infusion should be stopped or, if necessary, continued at a reduced dosage.

Reporting of suspected adverse reactions
Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of Drug Treatment” that appears on the homepage of the Ministry of Health’s website (www.health.gov.il) which links to an online form for reporting side effects, or by following this link: https://sideeffects.health.gov.il, and by emailing the Registration Holder's Patient Safety Unit at: drugsafety@neopharmgroup.com