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 Adverse Cases

Back Reported Adverse Drug Reaction Cases
Ezetimibe and depression - A possible signal

Ezetimibe (Ezetrol, Indian Brands: Ezedoc, Ezenta, Ezet, Ezetib, Ezzicad, Imbiba and Zetica) was registered in Australia in June 2003 for treatment of hypercholesterolaemia. Since then, ADRAC has received 265 reports of suspected adverse reactions associated with the use of this drug. Twelve of the reports describe depression (9) or depressed mood (3) in patients aged 60 to 82 years. In all cases, ezetimibe was the sole suspected drug. An unusual feature was the rapid onset of symptoms - within four days in 7 of the reports and at 4-6 weeks in another 3. In one report, the symptoms resolved after the dose was reduced from 10 mg to 5 mg daily, and another report described exacerbation of pre-existing depression after the second dose. In 5 patients, symptoms abated on withdrawal of ezetimibe but recurred on rechallenge. One of these documented 2 positive rechallenges with identical time to onset and noted suicidal ideation after continued use of ezetimibe. In addition to the 5 reports of positive rechallenges 4 patients had recovered after ceasing ezetimibe and a further patient was recovering with antidepressant treatment after withdrawal of ezetimibe.

Reports of depression/depressed mood, as a proportion of total reports received, are higher for ezetimibe (4.5%) than for other hypolipidaemic agents: 3% for pravastatin (16/511) and simvastatin (86/2,784); 2.4% for atorvastatin (39/1,573) and fluvastatin (6/255); 1.9% for gemfibrozil (12/619); and for the database as a whole (1.4%).

The Ezetrol Product Information does not mention depression as a finding in clinical trials of this medicine.1 Further, depression occurs commonly from other causes. However, the pattern of reporting suggests a possible causal association between ezetimibe and depression, particularly in elderly patients in the early phase of treatment, where careful monitoring is advisable. ADRAC will continue to monitor reports of depression in association with ezetimibe.

  1. Ezetrol (ezetimibe) Product Information. Merck Sharp & Dohme (Aust.) Pty Ltd (version dated Nov. 2005).
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Australian Adverse Drug Reactions Bulletin, Volume 5, Number 5, October 2006
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