The Risks and
Side Effects of Prescription Acne Medications
Hull, Peter R.,
D’Arcy, Carl
Isotretinoin Use and Subsequent
Depression and Suicide: Presenting the Evidence.
American Journal of Clinical Dermatology;
2003, Vol. 4 Issue 7, p493-505
The purpose of this meta-analysis was to evaluate the evidence of a possible cause-effect relationship between the use of isotretinoin in the treatment of patients with acne and depression, suicide and other psychiatric adverse events. The growing number of reported cases of depression and suicide associated with isotretinoin use has received extensive media coverage and has caused increasing concern for physicians and patients alike. It has also triggered implicit warnings from regulators, including depression-related, patient-informed consent forms. Despite this, there is a clear trend toward using isotretinoin in the treatment of milder forms of acne with increasing numbers of patients being exposed to the drug.
The researchers reviewed available databases and studies and with a view to determining whether there is an association, what is the nature of that association, if there is a plausible biological mechanism of action, the validity and reliability of measures used and the strength of study designs.
The manufacturer of Accutane (isotretinoin) Hoffmann-La Roche estimated that by April 2001 approximately twelve million patients worldwide have used isotretinoin, five million of those were in the US. A Hoffmann-La Roche sponsored epidemiological study, which compared treatment with isotretinoin with antibiotic treatment, failed to find any evidence of an association between isotretinoin and depression or suicide. The study used Canadian and British databases to compare the incidence of adverse psychiatric events in the two groups. However, the design of the study was flawed and the evidence was deemed inconclusive.
The US FDA's Adverse Event Reporting System (AERS) contains almost 23,000 reports for isotretinoin from its approval in 1982 to December 2002. As of November 30, 2002, AERS contained 3,104 reports worldwide with at least one reported psychiatric event. There were 173 reports of suicide worldwide in association with isotretinoin, only 37 in the US. It should be noted that AERS is based on voluntary reporting by physicians and pharmacists either to the FDA directly or to the drug manufacturer. It is believed that adverse events are substantially under-reported.
The researchers conducted a MEDLINE search of medical literature published between January 1966 and May 14 2003. They found 24 documented cases of isotretinoin associated depression, with 3 suicides. One additional patient committed suicide during the fourth month of isotretinoin treatment and 3 further patients attempted suicide by taking an overdose of isotretinoin.
The study concluded that there is a strong signal pointing to an association between isotretinoin and depression. Although a pharmacological mechanism that would account for psychiatric symptomatology as a result of isotretinoin treatment has not been found, isotretinoin is a retinoid receptor agonist and retinoid receptors are widely distributed in the brain. More research is needed to ascertain whether they have a role in depression. However, the obvious benefit of isotretinoin in treating acne should encourage continued use, although "patients and their relatives must be informed and depressive symptoms should be actively assessed at each visit and, if necessary, referral to a psychiatrist, antidepressant therapy or discontinuation of isotretinoin should be considered."
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