FDA label 1e88b000-0e22-44d4-9934-7c0e47876685

WARNINGS Ethiodol is not intended for use in bronchography and, therefore, is not to be introduced into the bronchial tree. A history of sensitivity to iodine or to other contrast materials is not an absolute contraindication to Ethiodol, but calls for extreme caution. All procedures utilizing contrast media carry a definite risk of adverse reactions. While most reactions are minor, life threatening and fatal reactions may occur without warning. The risk/benefit factor should always be carefully evaluated. At all times a fully equipped emergency cart and resuscitation equipment should be readily available, and personnel competent in recognizing and treating reactions of all severity should be on hand.

WARNINGS The use of intralymphatic Ethiodol presents a significant hazard in patients with pre-existing pulmonary disease characterized by a decrease in pulmonary diffusing capacity and/or pulmonary blood flow. A few fatalities have been noted in such patients. With reference to this potential complication, recent studies indicate a significant decrease in both pulmonary diffusing capacity and pulmonary capillary blood flow following Ethiodol lymphography without appreciable concomitant clinical manifestations. Also, care should be exercised in patients with other types of pulmonary disease in view of the more frequent incidence of overt pulmonary complications such as pulmonary infarction, in these groups. However, it is to be noted that pulmonary infarction, although rare, has occurred in patients without evidence of pre-existing pulmonary disease. The safety of intralymphatic Ethiodol has not been established in pregnant women, and accordingly, its use should be restricted to such situations where it is deemed necessary.

ADVERSE REACTIONS Hypersensitivity reactions, foreign body reactions and exacerbation of pelvic inflammatory disease, although infrequent, have been reported. In an occasional patient, abdominal pains may occur. Such pains may be the result of tubal torsion, or possibly due to too rapid a rate of instillation or excessive pressure, or both. The condition is usually only transitory, lasting one or two hours at most, and may be relieved by the administration of any of the commonly used analgesics.

ADVERSE REACTIONS The occasional observation of pulmonary Ethiodol embolization (infarction) several hours after injection has been reported. This was noticed more frequently when excessive amounts of Ethiodol have been injected, in the presence of marked lymphatic obstruction or through accidental intravenous injection. Radiologic manifestations are fine, granular stippling throughout both lung fields. The clinical symptoms usually noted have been mild, consisting of moderate temperature elevation, dyspnea, and cough. However, severe acute symptoms developed in two patients both of whom were severely ill and required extensive care. 2 Fuchs 3 experienced 1 severe and 3 minor complications in a series of 20 bilateral procedures. Two are described by the author as cardiovascular collapse occurring at two hours respectively following the completion of the procedure. It was postulated that minute emboli may have been causative. Recovery was rapid and complete in both instances. The occurrence of pulmonary invasion may be minimized if radiographic confirmation of intralymphatic (rather than venous) injection is secured, and the procedure discontinued when the medium becomes visible in the thoracic duct or the presence of lymphatic obstruction is noticed. While rare, other side effects reported include transient fever, lymphangitis, iodism (headache, soreness of mouth and pharynx, coryza and skin rash), allergic dermatitis, and lipogranuloma formation. Delayed wound healing at the site of incision and secondary infection are occasionally seen, and can be prevented or minimized by adhering to a strict sterile technique. Transient edema or temporary exacerbation of preexisting lymphedema, as well as thrombophlebitis have also been reported. In the extremely rare presence of concomitant lymphatic and inferior vena cava obstruction the contrast medium may be shunted partially to the liver, resulting in hepatic embolization. Also, when accidental intravenous administration of Ethiodol results in a considerable amount of this medium entering the circulation, embolization other than pulmonary may occur as reported in 2 cases 4 . Both cases developed a transient, psychotic-like manifestation, which in all probability stemmed from the entrance of fine oil droplets into the cerebral circulation. Recovery was uneventful and complete without evidence of neurological sequelae.