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Bupropion FDA Alerts

The FDA Alerts below may be specifically about bupropion or relate to a group or class of drugs which include bupropion.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for bupropion

Antidepressant Medication Products

May 2, 2007 | Audience: Healthcare professionals, consumers[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes.

[May 02, 2007 - Press Release - FDA]
[May 02, 2007 - Antidepressant Information Page - FDA]

Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults

Mar 22, 2004 | Audience: Neuropsychiatric healthcare professionals and consumersThe FDA asked manufacturers of the following antidepressant drugs to include in their labeling a Warning statement that recommends close observation of adult and pediatric patients for worsening depression or the emergence of suicidality when treated with these agents. The drugs that are the focus of this new Warning are: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine).

[March 22, 2004 Public Health Advisory - FDA]
[March 22, 2004 Drug Information Page - FDA]

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