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This retrospective, managed-care database study assessed the risk of congenital malformations overall and cardiovascular malformations specifically, following exposure to bupropion in the first trimester compared to the risk of these malformations following exposure to other antidepressants in the first trimester and bupropion outside of the first trimester. This study included 7,005 infants with antidepressant exposure during pregnancy, 1,213 of whom were exposed to bupropion in the first trimester. The study showed no greater risk for congenital malformations overall or cardiovascular malformations specifically, following first trimester bupropion exposure compared to exposure to all other antidepressants in the first trimester, or bupropion outside of the first trimester. The results of this study have not been corroborated. ORDER WELLBUTRIN 150 MG SR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of WELLBUTRIN SR on labor and delivery in ORDER WELLBUTRIN 150 MG is unknown. Like many other drugs, bupropion and its metabolites are secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from WELLBUTRIN SR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and ORDER WELLBUTRIN 150 MG Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders). Anyone considering the use of WELLBUTRIN SR in a child or adolescent must balance the potential risks with the clinical need. Of the approximately 6,000 patients who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation studies), 275 were 65 and over and 47 were 75 and over. In addition, several hundred patients 65 and over participated in clinical trials using the immediate-release formulation of bupropion (depression studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. A single-dose pharmacokinetic study demonstrated that the disposition of bupropion and its metabolites in elderly subjects was similar to that of younger subjects; however, another pharmacokinetic study, single and multiple ORDER WELLBUTRIN 150 MG, has suggested that the elderly are at increased risk for accumulation of bupropion and its metabolites (see CLINICAL PHARMACOLOGY). Bupropion is extensively ORDER WELLBUTRIN 150 MG in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of toxic reaction to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased ORDER WELLBUTRIN 150 MG function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS Renal Impairment and DOSAGE AND ADMINISTRATION). The ORDER WELLBUTRIN 150 MG included under the Incidence in Controlled Trials subsection of ADVERSE REACTIONS is based primarily on data from controlled clinical trials with WELLBUTRIN SR. Information on additional adverse events associated with the sustained-release formulation of bupropion in smoking cessation trials, as well as the immediate-release formulation of bupropion, is included in a separate section (see Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion). Incidence in Controlled Trials With Wellbutrin SR Adverse Events Associated With ORDER WELLBUTRIN 150 MG of Treatment Among Patients Treated With Wellbutrin SR In placebo-controlled clinical trials, 9 and 11 of patients treated with 300 and 400 mgday, respectively, of WELLBUTRIN SR and 4 of patients treated with placebo discontinued treatment due to adverse events. The specific ORDER WELLBUTRIN 150 MG events in these trials that led to discontinuation in at least 1 of patients treated with either 300 ORDER WELLBUTRIN 150 MG 400 mgday of WELLBUTRIN SR and at a rate at least twice the placebo rate are listed in Table 4. Table 4. Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials Adverse Event Term at an Incidence of 1 or More Among Patients Treated With Wellbutrin SR Table 5 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mgday of WELLBUTRIN SR and with placebo in placebo-controlled trials.


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