The narrative summaries for these cases were
reviewed and, with the exception of Patient 403/3227, the adverse events were
not felt to be reasonably attributable to the study drug. Patient 403/3227 experienced dyspnea, blue
lips, hand and foot swelling, periorbital and perioral edema, and extremity
petechiae after taking a dose of verapamil which she took chronically for
hypertension, with a peanut butter sandwich on Day 25 of treatment with
Wellbutrin SR 300 mg/day. She was
treated in the local emergency room with parenteral Benadryl, steroids, and
epinephrine and recovered. However,
even in this case, a causal link to Wellbutrin SR is difficult to assess
because verapamil and peanut butter were felt to be equally likely etiologies
of this anaphylactic reaction.
Only three non-serious adverse events resulting in
dropout were not observed in previous databases: chickenpox, anorgasmia, and
tongue blisters. Each was reported in
one patient. The case of chickenpox was
felt to be unlikely to be drug related.
The 53 year old male with anorgasmia experienced this event after taking
Wellbutrin SR 300 mg/day for 106 days; no other information was available. The patient with tongue blisters (403/1023)
was a 41 year old Indian male who experienced this event after 30 days of
treatment with Wellbutrin SR 300 mg/day; he apparently continued treatment for
another 11 days before stopping treatment.
This event may have been related to Wellbutrin SR.
None of the data contained in this safety update
changes previous conclusions regarding the overall safety profile of Wellbutrin
SR.
III.
Foreign
Regulatory Actions
Neither the immediate-release nor sustained release
formulations of bupropion are marketed outside the United States. Applications to market Wellbutrin Tablets
were submitted to Canada (1981) and the U.K. (1983); after deficiency letters
were issued by both agencies (1986 and 1983, respectively), these applications
were withdrawn.
A clinical trial exemption (CTX) to investigate
Wellbutrin SR Tablets as an aid to smoking cessation was submitted to the U.K.
in January 1996 and was rejected the following month related to several safety
issues, many of which were cited in the 1983 deficiency letter (including
seizures, potential carcinogenicity and liver toxicity in animals,
Page 3
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index