On-label on the table: what the package insert informs us about the tolerability profile of oral atypical antipsychotics, and what it does not

Abstract

Introduction: The product label is commonly used as an authoritative source for drug information, especially for new medications that have a limited published evidence base. Key elements of the product label are descriptions of safety and tolerability.

Areas covered: The package inserts of oral atypical antipsychotics approved by the US Food and Drug Administration are reviewed with regard to product safety and tolerability.

Expert opinion: Product labels of oral second-generation antipsychotics provide an opportunity to indirectly compare the safety and tolerability profiles of each agent. Some warnings and precautions are found across the entire class; other warnings and precautions may be worded somewhat differently from agent to agent and some may be unique to a particular medication. Guidance is provided in the product label regarding use in specific populations, drug–drug interactions and other issues relating to dosing. Common adverse reactions are tabulated but the reader is left to calculate the risk differences from placebo and number needed to harm. The latter can be helpful in appraising potential differences in discontinuation rates because of adverse reactions, the proportion gaining at least 7% in body weight from baseline in short-term studies, the proportion experiencing somnolence and the proportion experiencing akathisia. The product label, although limited in terms of being product-specific, is often the most authoritative and accessible source of information about new agents in the marketplace. However, clinicians will need to mind the gap between the efficacy and preliminary safety and tolerability data provided by registration trials and the real-world effectiveness of medications when used in the clinic.

Keywords:

• atypical antipsychotic
• FDA
• product label
• safety
• tolerability

Notes

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