An analysis of reports of depression and suicide in patients treated with isotretinoin

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 isot retinoin and to consider the nature of a possible association between isotr etinoin 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 F DAs Adverse Event Reporting System database. Results. From marketing of isotretinoin in 1982 to May 2000, the FDA receiv ed reports of 37 US patients treated with isotretinoin who committed suicid e; 110 who were hospitalized for depression, suicidal ideation, or suicide attempt; and 284 with nonhospitalized depression, for a total of 431 patien ts. Factors suggesting a possible association between isotretinoin and depr ession include a temporal association between use of the drug and depressio n, positive dechallenges (often with psychiatric treatment), positive recha llenges, and possible biologic plausibility. Compared with all drugs in the FDAs Adverse Event Reporting System database to June 2000, isotretinoin ra nked within the top 10 for number of reports of depression and suicide atte mpt. Conclusion: The FDA has received reports of depression, suicidal ideation, suicide attempt, and suicide in patients treated with isotretinoin. Additio nal studies are needed to determine whether isotretinoin causes depression and to identify susceptible persons. In the meantime, physicians are advise d to inform patients prescribed isotretinoin (and parents, if appropriate) of the possibility of development or worsening of depression. They should a dvise patients (and parents) to immediately report mood swings and symptoms suggestive of depression such as sadness, crying, loss of appetite, unusua l fatigue, withdrawal, and inability to concentrate so that patients can be promptly evaluated for appropriate treatment, including consideration of d rug discontinuation and referral for psychiatric care.