Healthy Skepticism Library item: 1448

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Brodie MJ, Pellock JM.
Taming the brain storms: felbamate updated.
Lancet 1995 Oct 7; 346:(8980):918-9

Keywords:
*analysis felbamate Carter Wallace safety & risk information new drugs journal advertisements EVALUATION OF PROMOTION: DRUG SAFETY EVALUATION OF PROMOTION: JOURNAL ADVERTISEMENTS

Notes:

When felbamate became available for general prescription, the manufacturer, Carter Wallace, undertook a major promotional campaign emphasizing a favourable adverse experience profile. Statements such as “most adverse experiences are generally mild and transient” were widely touted in the same advertisements. Shortly after the launch, it became apparent that felbamate was not as well tolerated in clinical practice as it had been during the clinical trial program. Some checks should be incorporated in the registration system for new chemical entities, especially those with novel mechanisms of action such as felbamate.