None of the adverse events listed above occurred at a
rate greater than five per cent in at least one bupropion
sustained-release dose group, and were seen
at least twice as frequently in one or more bupropion sustained-release groups
as among placebo patients.
AD8.5.3 Weight
No patient treated with bupropion sustained-release
in study 212 had to discontinue the drug because of changes in weight. Among the 359 patients for whom
discontinuation weight data was available, the mean weight change at
discontinuation for the placebo, bupropion sustained-release 150 mg, and
bupropion sustained-release 300 mg groups was a decrease of 0.3, 1.0, and 1.7
pounds, respectively. The difference
between the effect on the 300 mg group and the placebo groups was significant
at p <0.01. The difference between
the 150 mg group and the placebo group was not significant.
AD8.6 Summary of Important Adverse Events Considered Drug Related
Although the incidence of drug-related important
adverse events was small, these sections are identified to complement the data
summarized already in the main text of this review.
AD 8.6.2 Allergic Phenomena
Three patients (1.0% of 302 total bupropion sustained-release-treated patients) in protocol 212 discontinued bupropion sustained-release due to rash, pruritus, or urticaria. Zero out of 154 patients in the placebo-treated group of protocol 212 discontinued participation because of an allergic reaction.
AD8.6.3 Anxious States
Three patients (1% of 302 total bupropion
sustained-release-treated patients) in protocol 212 discontinued bupropion
sustained-release due to anxious phenomenona, including agitation, nervousness,
anxiety, and panic attacks. One (0.6%)
of the 154 patients in the placebo-treated group of protocol 212 discontinued
participation because of an anxious state.
In protocol 212, panic attacks not seen in the medication-treated
patients.
AD8.6.4 Theoretical Risk of Treatment-Emergent Mania
Mania was not reported as a treatment-emergent
adverse effect of bupropion sustained-release in protocol 212.
AD8.7 Summary of Important Adverse Events Considered Not Drug Related
No deaths occurred in the course of protocol
212. Three serious events that were
probably not drug-related occurred to subjects taking bupropion
sustained-release in protocol 212: diagnosis of cervical carcinoma, excision of
a pre-existing papillary cell carcinoma, and spontaneous abortion in one
subject eight days after discontinuation from the study. All treatment-emergent serious events from
protocol 212 that are considered to be unlikely to be related to bupropion
sustained-release are listed in Appendix AD8.7.
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