GlaxoSmithKline's (GSK) Wellbutrin XL has been approved to be the first drug for treating patients with a history of seasonal affective disorder (SAD), the U.S. FDA announced. Wellbutrin XL (bupropion HCl extended-release tablets) was previously approved for treatment of major depressive disorder.
The approval, however, comes with requirement for a black box warning on the drug's labeling concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications. This stems from an FDA announcement in early 2004 that cited the possible risk of suicide with several antidepressants -- GSK's Wellbutrin and Paxil (paroxetine), Eli Lilly's Prozac (fluoxetine), Pfizer's Zoloft (sertraline), Solvay's Luvox (fluvoxamine), Forest Laboratories' Celexa (citalopram) and Lexapro (escitalopram), Wyeth's Effexor (venlafaxine), Bristol-Myers Squibb's Serzone (nefazodone) and Organon's Remeron (mirtazapine).
In addition, the FDA's announcement points out that "Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning."
SAD, which affects approximately 10 million people in the U.S., is characterized by recurrent major depressive episodes -- often lasting for up to six months -- that usually coincide with the decrease of daylight during autumn and winter.