Information about a medicine’s important side effects and what to do about them is provided in the Warnings section. Clinically significant adverse events are described, along with other potential safety hazards, limitations in the medicine’s use due to those reactions and hazards, and steps to take if they occur. The defining criterion for inclusion under Warnings is that a reasonable association must have been established between the adverse event or risk and the medicine—although a definitive causal relationship need not be established.
The Warnings section may also provide information about nonapproved uses of the medicine. This would be the case if the medicine either has been commonly used for a condition, or there is a common belief that the medicine is effective for a condition, but the preponderance of evidence demonstrates that the medicine is not effective and this usage of the medicine is associated with a clinically significant risk or hazard. Note that, because such situations involve nonapproved uses of the medicine, they would not be covered in other sections of the PI such as Indications and Usage or Contraindications.
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