D.       Post-Marketing Experience

Bupropion has been marketed in the U.S. for depression since 1989.  Since that time, over 4 million patients have received bupropion treatment.  The sponsor states that no new significant safety concerns have been identified that were not observed in clinical trials using the immediate release formulation of bupropion.  Since the extended release formulation of bupropion is not marketed in the U.S. or elsewhere, there have been no spontaneously reported adverse events from post-marketing experiences that have been identified in the GlaxoSmithKline adverse events database.

 

IV.  Conclusions

·       WELLBUTRIN XL appears to be reasonably safe and well tolerated when given to healthy subjects at a dose of 300 mg/day for up to 10 days.

·       Limited data up the use of WELLBUTRIN XL in subjects with Seasonal Affective Disorder suggest that there have been no serious or unexpected safety concerns.

·       The safety profile of WELLBUTRIN XL appears to be similar to those of WELLBUTRIN IR and WELLBUTRIN SR.  No serious, new, or unexpected adverse events have been reported thus far.

·       There are some limitations in drawing conclusions about the safety of WELLBUTRIN XL: 1) only a relatively small number of healthy and depressed subjects have been exposed to the drug for fairly short periods; 2) There is very little clinical laboratory and ECG data available for subjects exposed to WELLBUTRIN XL.  In most studies, only baseline ECG & clinical laboratory tests were performed.

·       We will continue to monitor the safety profile of WELLBUTRIN XL as it is used in ongoing and proposed trials.

 

______________________________

Robert Levin, M.D., February 14, 2003

Medical Reviewer,

FDA CDER ODE1 DNDP HFD 120

 

cc:  HFD 120

       T Laughren

       P Andreason

       D Bates

 

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page