A.       Deaths, SAE, Discontinuations due to AE, and Common AE

There were no deaths in these studies.  There were 3 serious adverse events, 19 discontinuations due to adverse events, and one pregnancy during the trials.  Treatment assignments remain blinded, except for in the case of the bioavailability study.

 

Serious Adverse Events

1.         (BIOVAIL; bupropion SR for 3 days).  Knee pain and swelling.  Action: hospitalization, intravenous antibiotics, discontinued from study.  Resolved.

2.         (AK130936; treatment unknown).  Cardiac Arrest in a man with coronary artery disease.  He had concomitant treatment with dextroamphetamine.  The event occurred after 6 months of study treatment and 10 days after the last dose.

3.         He was hospitalized, had stent placed in coronary artery.  Resolved.

4.         (AK130936; treatment unknown).  Appendicitis, requiring appendectomy.  The event occurred during the fifth month of study treatment.

 

Discontinuations due to Adverse Events

Four occurred in the bioavailability study.  The adverse events were rash/urticaria, knee pain and swelling, and two cases of upper respiratory infection.  The rash and urticaria resolved upon discontinuing study drug.  For the 15 cases in the 5 clinical studies, the specific adverse events leading to discontinuation were not specified.  Appendicitis was the reason for one of the cases in Study 936.  In studies 926, 927, 930, 936, and 934, there were 4, 7, 0, 2, and 2 discontinuations due to adverse events, respectively.  Treatment assignments are unknown.

 

Pregnancy

The pregnancy occurred in a 40-year-old woman participating in Study 930.  She was exposed to blinded study drug before conception and during the early portion of the first trimester.  The outcome is unknown.

 

Most Commonly Reported Adverse Events

In AKBIOVAIL2572, subjects had crossover treatment with WELLBUTRIN XL and WELLBUTRIN SR, each for 3 days.  During treatment with the XL formulation, 18 of the 52 subjects reported adverse events, and during treatment with the SR formulation, 16 of the 53 subjects reported adverse events.  The most common adverse events were constipation (10% vs. 6%), nausea (6% vs. 4%), and headache (4% vs. 6%).  The sponsor did not provide data regarding common adverse events reported in the clinical studies.

 

IV.  Conclusion

The sponsor has provided an appropriated safety update.  Data from this update and the previous update suggest that WELLBUTRIN XL is reasonably safe and well tolerated in adult subjects with Major Depression, Seasonal Affective Disorder, and Attention Deficit-Hyperactivity Disorder.  Once the treatment assignments are no longer blinded, it would be useful to have more information about the adverse events reported in these studies.

 

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