Monoethanolamine oleate Other names: cis-9-Octadecenoic acid, ethanolamine salt beta-Hydroxyethylammonium oleate

(Teratogenic Effects: Pregnancy Category C)

Animal reproduction studies have not been conducted with monoethanolamine oleate. It is also not known whether monoethanolamine oleate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Monoethanolamine oleate should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when monoethanolamine oleate is administered to a nursing woman.

The reported frequency of complications/adverse events per injection session was 13%. The most common complications were pleural effusion/infiltration (2.1%), esophageal ulcer (2.1 ), pyrexia (1.8), retrosterual pain (1.6%), esophageal stricture (1.3%), and pneumonia (1.2%).

Other adverse local esophageal reactions have also been reported at rates of 0.1 to 0.4%, including esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, ulceration, stricture, necrosis, periesophageal abscess and perforation. These complications appear to be dependent upon the dose and the patient’s clinical state.

Bacteremia has been observed in patients following injection of esophageal varices with ETHAMOLlN. Pyrexia and retrosternal pain are not infrequently observed during the post-injection period. Fatal aspiration pneumonia has occurred in patients with esophageal varices who underwent monoethanolamine oleate sclerotherapy. Anaphylactic shock and acute renal failure with spontaneous recovery have occurred. A case of disseminated intravascular coagulation has been reported.

Spinal cord paralysis due to occlusion of the anterior spinal artery has been reported in one child eight hours after monoethanolamine oleate sclerotherapy.