Product Name:
{drug name}
Product Type:
Registered
Intended Use:
Promotional Material
Assessment Type:
Historical Search - Risk of Impartial / Imbalanced Message
Assessment Outcome
The promotional material for {drug name} may present benefits prominently, potentially with more emphasis compared to risk information. It could be beneficial to evaluate how this presentation might impact the overall balance of information provided to patients.
Relevant Historical Context
Example 1: Xeris Pharmaceuticals, Inc. (August 14, 2020)
A TV ad for Gvoke (glucagon injection for severe hypoglycemia) was found to minimize risks by omitting certain contraindications and information about potential allergic reactions.
Consideration: It may be worth reviewing the {drug name} brochure to ensure all relevant contraindications and potential serious risks are adequately presented. This could help prevent any unintended minimization of important safety information.
View FDA DocumentExample 2: CooperSurgical, Inc. (July 25, 2019)
A TV ad for ParaGard (intrauterine device) was found to minimize risks by omitting details about serious complications and potentially overshadowing risk information with distracting visuals.
Consideration: It might be helpful to evaluate the presentation of risk information in the {drug name} brochure, considering factors such as font size, placement, and any competing visual elements that could potentially distract from this important information.
View FDA DocumentExample 3: VIVUS, Inc. (May 22, 2019)
The consumer website for Qsymia (weight management) was found to selectively present favorable efficacy data without proper context.
Consideration: It may be beneficial to review how the benefits of {drug name} are presented in the brochure. Ensuring that efficacy claims are properly contextualized could help provide a more balanced view of the drug's effects.
View FDA DocumentSuggestions for Consideration
Risk Information Presentation
Consider reviewing the brochure to ensure it includes comprehensive information about common and serious side effects, contraindications, warnings, and precautions associated with {drug name}. Referencing the FDA-approved product labeling could help ensure accuracy and completeness.
Benefit Presentation
It may be helpful to review how the benefits of {drug name} are presented for each indicated condition. Consider providing context about the type and magnitude of improvement observed in clinical trials, and including any relevant limitations of use.
Visual Presentation of Information
Evaluating the visual presentation of risk information could be beneficial. Consider assessing whether the font size, placement, and visual style of risk information are comparable to the presentation of benefits, and whether there are any elements that might inadvertently distract from risk information.