Improving Patient Education and Reducing Risk

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2001;7(7) 

In This Article

Association with Depression and Suicide

While much work has been done in the area of preventing isotretinoin-exposed pregnancies, there has also been considerable attention recently to the association between psychiatric symptoms and this drug. In October 2000, Rep. Bart Stupak of Michigan began a public media campaign following the suicide of his 17 year old son. Stupak believes the suicide to be related to his son's use of isotretinoin over the 7 months prior to his death.[16]

The potential for a link between isotretinoin and depression or suicide has been suggested for many years. Reports of psychiatric adverse events began shortly after the introduction of the drug. Between 1982 and 2000, the FDA accumulated 431 reports of depression, suicidal ideation, suicide attempts, or suicide in patients taking isotretinoin. Thirty-seven of the reports were suicides. Of those patients, the overwhelming majority (84%) were male, with an average age of 17 years. A prior history of psychiatric illness was present in 8 of the cases.[17]

Roche first amended the product insert for Accutane® to list depression as an adverse effect in 1985. In February 1998, the FDA approved a further change in labeling to include a bold-face (black box) warning about psychiatric disorders, including suicide.[12,18] This last modification was made a full year after a similar change was made in France, calling into question the rapidity with which this important information was provided to prescribers in the United States.[18]

The role of isotretinoin in causing psychiatric illness remains unproven. A recent review of databases from Canada and the United Kingdom, including over 7,000 patients, failed to identify any evidence supporting a link between depression or suicide and isotretinoin.[19] Last September, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee reviewed all of the available data and concluded that causality had not been established.

Despite the lack of conclusive evidence, there is clearly a need to educate patients about this potential risk. A separate consent form has been developed by Roche which focuses on psychiatric adverse events. This new consent form was released in January 2001, with an initial mass mailing to prescribers at the same time it was added to the product insert. On the form, patients are required to disclose any symptoms of depression or psychosis in themselves or family members prior to initiating therapy. The form also stipulates that patients promptly inform their prescriber of any psychiatric symptoms during treatment.[2,12] The potential for psychiatric adverse events has also been included in the FDA MedGuide.[13]

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....