Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Lethargy
Clinical narrative: Information has been received from a physician concerning a 66 year old male with a history of gall bladder disease, cholelithiasis and stent insertions for known cardiovascular disease who in 2002, prior to traveling, was vaccinated with a dose of hepatitis B virus vaccine. On 10/4/03, the patient was found to have a positive IgM core antibody for hepatitis B which implied acute hepatitis B. A hepatologist was consulted who said that this finding can rarely be seen with a drug reaction. The reporting physician was leaning towards a diagnosis of failed hepatitis B vaccine with subsequent hepatitis B infection, although drug induced hepatitis was still in the differential. The patient was doing fair with weakness, lethargy, anorexia and jaundice. As of 10/14/03, his bilirubin was between 12-15 and his prothrombin time was slightly elevated. Clopidogrel bisulfate and aspirin were recently discontinued, and the patient continued on a beta blocker and metoprolol succinate. The patient was noted to be taking the following medications: ezetimibe, pravastatin Na, clopidogrel bisulfate, aspirin, a beta blocker and metoprolol succinate. The patient began taking ezetimibe around 7/23/03. Subsequently, the patient experienced acute hepatitis B. On 8/11/03 the patient presented to the physician's office with a severe right upper quadrant pain. On 8/19/03 the patient's liver function tests were found in the 400 ranges. On 8/11/03 therapy with ezetimibe was discontinued. The physician described the reaction as a severe liver reaction. The patient had been taken off pravastatin Na and ezetimibe. The patient outcome was not reported. Follow up information was received from the nurse who reported that on 8/3/03, the patient was seen by the physician, a GI specialist, for complaints of abdominal pain, jaundice and abnormal LFT's. The nurse had no information pertaining to treatment for the events. On 8/11/03 therapy with ezetimibe was discontinued. On 10/2/03, the patient had repeat lab findings. As of 10/8/03 the patient's right upper quadrant pain was reported as intermittent. The nurse reported that the physician was questioning if ezetimibe may have caused the increase in the liver function tests. As of 10/8/03, the patient remained off ezetimibe. Additional follow up was received from the physician who reported that the patient was placed on therapy with ezetimibe and in July 2003, after 3 weeks of therapy with ezetimibe, the patient complained of abdominal pain. Pravastatin Na and ezetimibe were discontinued at that time. The patient had a known history of gall stones disease. The patient also received the hepatitis B vaccine 1 year ago, prior to traveling, after it was determined that he had negative serology for hepatitis B. Since 7/03, he has had cholestasis and slowly rising liver function tests with transaminases currently in the 600-700. He was felt to have obstructive jaundice but ERCP, MRCP and CT scan showed a normal liver, stones in bladder and no common duct disease. Upon internal review, acute hepatitis B was considered to be an other important medical event (OMIC). Additional information is not expected.