If rFVIIa is administered, the patient's next of kin should be informed that rFVIIa is being used outside the currently approved indications (off-label use), especially because the use of rFVIIa may increase the risk of thromboembolic complications [ 319].
Because rFVIIa is not approved for any of the indications discussed in this publication, the patient's next of kin should be informed that rFVIIa is being used outside the currently approved indications (off-label use).
If rFVIIa is administered, the patient's next of kin should be informed that rFVIIa is being used outside the currently approved indications (off-label use), especially since the use of rFVIIa may increase the risk of thromboembolic complications [ 516].
Sandro Scarpelini and Sandro Rizoli We understand the clinical scenario and debate question as whether one should administer a drug outside its licensed indications (off-label) to treat a condition (upper gastrointestinal bleeding) without any evidence for the drug's efficacy and safety.
However, neither of these last two sources takes advantage of the scientific literature, in which drug-induced phenomena are documented in a variety of settings, such as in vitro and in vivo methods, across species, for approved indications, off-label uses and for drugs in development.
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Indications for off-label use were: substance withdrawal (50%), delirium (71%), and sedation (29%).
The most common indications for off-label prescribing were diagnoses of cough (n = 18; 12%) and acute bronchitis (n = 16; 11%) or symptoms of cough, airway obstruction and dyspnoea (n = 21; 14%).
A one-size-fits-all policy is unlikely to achieve the desired goals; as a result, the identification of a suite of alternative policies, together with clear indications of their trade-offs, is crucial to accommodate the diversity of stakeholders' preferences.
Thus, this definition excludes adverse events due to drug quality, administration with no indications, and off-label use.
Lastly, given the focus on pDPN patients, the results of this study should not be considered generalizable to other FDA-approved indications or off-label uses.
