II.                RISK ASSESSMENT

 

A.      EXPERT PANEL DISCUSSION

 

An Expert Panel discussion was held by DMETS to gather professional opinions on the safety of the proprietary name “Wellbutrin XL”.  Potential concerns regarding drug marketing and promotion related to the proposed names were also discussed.  This group is composed of DMETS Medication Errors Prevention Staff and representation from the Division of Drug Marketing, Advertising, and Communications (DDMAC).  The group relies on their clinical and other professional experiences and a number of standard references when making a decision on the acceptability of a proprietary name.

 

1.       Since the completion of the initial review of the proprietary name Wellbutrin XL (ODS Consult 02-0031), the Expert Panel had not identified any proprietary names, thought to have the potential for confusion with Wellbutrin XL.  However, the Expert Panel raised concerns regarding the confusion of the “XL” product with the “SR” product and the immediate-release product currently on the marketplace.

 

2.       DDMAC did not have concerns the name Wellbutrin XL with regard to promotional claims.

 

B.     SAFETY EVALUATOR RISK ASSESSMENT

 

For reasons explained in earlier reviews (ODS Consults 02-0031, 02-031-1, -2, and –3) of the proprietary name, “Wellbutrin XL”, DMETS still has concerns with potential medication errors occurring between “Wellbutrin XL”, Wellbutrin SR, Wellbutrin, and Zyban.  However, DMETS believes that the risk of introducing an entirely new proprietary name for this once-a-day bupropion hydrochloride tablet would be greater than the addition of the name modifier “XL”.

 

The sponsor has taken the following steps to minimize the potential for medication errors between “Wellbutrin XL” and other approved dosage forms of bupropion hydrochloride.

 

1.       The sponsor has provided a risk management plan to educate patients and healthcare providers on the appropriate use of this once daily extended release formulation with respect to the other approved dosage formulations of bupropion hydrochloride.  Key messages will be directed to physicians, pharmacists, and patients to educate these groups on the appropriate use of Wellbutrin XL.

 

2.       The sponsor has addressed comments from the Division of Surveillance, Research, and Communication Support (DSRCS) regarding the patient information labeling from a March 24, 2003, Memo and DSRCS has provided the Division with additional comments (Memo of July 24, 2003) for the sponsor’s latest submission.

 

3.       The sponsor has satisfactorily addressed DMETS’ labeling comments and submitted draft labels and labeling.  With regard to DMETS’ concerns for a proposed Patient Sample Kit [one bottle of 150 mg strength (7 tablets) and one bottle of 300 mg strength (7 tablets)], the sponsor has decided not to develop a patient kit at this time.

 

In addition, the sponsor has made a commitment to submit all domestic actual medication error reports and potential medication error reports associated with Wellbutrin XL to the Agency as expedited reports (within 15 days.)

 

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