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COMMENTS AND OPINIONS
Relationship Between Headache and Depression in Users of Isotretinoin
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Reports of depression and serious depression in patients treated with isotretinoin (eg, Accutane [Hoffmann-La Roche Inc, Nutley, NJ], Amnesteem [Mylan Bertek Pharmaceuticals Inc, Morgantown, WVa]; Sotret [Ranbaxy Pharmaceuticals Inc, Princeton, NJ]; and Claravis [Barr Laboratories Inc, Pomona, NY]) have been submitted to the Food and Drug Administration (FDA)1 and entered into the Adverse Event Reporting System (AERS; the FDA’s database of voluntarily submitted suspected adverse drug reaction reports). In reviewing these reports, we noticed that patients with depression frequently reported accompanying physical symptoms, particularly headache. As a result, we tested the hypothesis that a relationship between headache and depression exists for isotretinoin and for all drugs in AERS.
We obtained the number of case counts of adverse event reports for all suspect drugs (vs concomitant drugs) entered in AERS with and without headache and with and without depression, constructed a 2 x 2 table, and performed statistical tests of a . . . [Full Text of this Article]
AUTHOR INFORMATION
Diane K. Wysowski, PhD;
Lynette Swartz, MEd, MBA
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