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Recent FDA MedWatch Warnings Compiled

ROCKVILLE, MD -- June 23, 2004 -- Below is a compilation of recent MedWatch Warnings issued by the FDA:

FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of Paxil (paroxetine hydrochloride) labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

Read the MedWatch 2004 safey summary, including links to the "Dear Healthcare Professional" letter and revised label, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm


FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, and WARNINGS sections of the Serzone labeling to encourage healthcare providers to engage in a thorough risk-benefit analysis, including consideration of the risk of hepatic failure associated with Serzone treatment, when deciding among alternative treatments available for depression. In addition, healthcare providers and consumers are cautioned about the need for close observation of patients being treated with antidepressants for clinical worsening of the symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may represent a worsening of the patient's condition.

Read the MedWatch 2004 safety summary, including links to the "Dear Healthcare Professional" letter and the revised label, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm


FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of Wellbutrin (bupropion hydrochloride) labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

Read the MedWatch 2004 safety summey, including links to the "Dear Healthcare Professional" letter and the revised label, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm.

Source: The Food and Drug Administration

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