Abstract:
BACKGROUND:The Food and Drug Administration (FDA) has received reports of depression and suicide in patients treated with isotretinoin. OBJECTIVE:Our purpose was to provide the number and describe the cases of depression and suicide reported to the FDA in US patients treated with isotretinoin and to consider the nature of a possible association between isotretinoin and depression. METHODS:An analysis was made of reports of depression, suicidal ideation, suicide attempt, and suicide in US isotretinoin users voluntarily submitted to the manufacturer and the FDA from 1982 to May 2000 and entered in the FDA's Adverse Event Reporting System database. RESULTS:From marketing of isotretinoin in 1982 to May 2000, the FDA received reports of 37 US patients treated with isotretinoin who committed suicide; 110 who were hospitalized for depression, suicidal ideation, or suicide attempt; and 284 with nonhospitalized depression, for a total of 431 patients. Factors suggesting a possible association between isotretinoin and depression include a temporal association between use of the drug and depression, positive dechallenges (often with psychiatric treatment), positive rechallenges, and possible biologic plausibility. Compared with all drugs in the FDA's Adverse Event Reporting System database to June 2000, isotretinoin ranked within the top 10 for number of reports of depression and suicide attempt. CONCLUSION:The FDA has received reports of depression, suicidal ideation, suicide attempt, and suicide in patients treated with isotretinoin. Additional studies are needed to determine whether isotretinoin causes depression and to identify susceptible persons. In the meantime, physicians are advised to inform patients prescribed isotretinoin (and parents, if appropriate) of the possibility of development or worsening of depression. They should advise patients (and parents) to immediately report mood swings and symptoms suggestive of depression such as sadness, crying, loss of appetite, unusual fatigue, withdrawal, and inability to concentrate so that patients can be promptly evaluated for appropriate treatment, including consideration of drug discontinuation and referral for psychiatric care.
journal_name
J Am Acad Dermatoljournal_title
Journal of the American Academy of Dermatologyauthors
Wysowski DK,Pitts M,Beitz Jdoi
10.1067/mjd.2001.117730subject
Has Abstractpub_date
2001-10-01 00:00:00pages
515-9issue
4eissn
0190-9622issn
1097-6787pii
S0190-9622(01)28089-Xjournal_volume
45pub_type
杂志文章abstract:BACKGROUND:Drug-specific T cells are involved in the pathogenesis of cutaneous adverse drug reactions (CADRs). OBJECTIVE:We sought to evaluate the diagnostic role of in vitro drug-induced release of interferon gamma in CADRs. METHODS:The study group consisted of 36 patients with CADRs after intake of 106 drugs that w...
journal_title:Journal of the American Academy of Dermatology
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abstract:BACKGROUND:The twin goals of long-term disease control and minimizing toxicities related to immunosuppression necessitate efforts to find effective steroid-sparing agents in the management of patients with autoimmune bullous diseases. Pemphigus especially requires a long view, because the disease can persist throughout...
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abstract::A patient who developed exfoliative erythroderma 11 days after the initiation of hydroxychloroquine treatment for psoriatic arthritis is presented. Our experience with her and the continued controversy regarding the incidence of adverse reactions in psoriatic patients to antimalarials prompted a detailed review of the...
journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
pub_type: 共识发展会议,杂志文章,评审
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更新日期:2000-01-01 00:00:00
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journal_title:Journal of the American Academy of Dermatology
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更新日期:1996-07-01 00:00:00
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journal_title:Journal of the American Academy of Dermatology
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更新日期:2003-12-01 00:00:00
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journal_title:Journal of the American Academy of Dermatology
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更新日期:1989-11-01 00:00:00
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
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journal_title:Journal of the American Academy of Dermatology
pub_type: 杂志文章
doi:10.1016/j.jaad.2005.02.015
更新日期:2005-08-01 00:00:00
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journal_title:Journal of the American Academy of Dermatology
pub_type: 杂志文章
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更新日期:2005-09-01 00:00:00
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