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The second one corresponds to pharmacological agents approved for some indications obtained with adults but not for all (ie restricted indication : e.g. sertraline approved in paediatry only for OCD but not for depression, risperidone approved only for the treatment of disruptive behaviors in children with subaverage IQs).
The use of a drug that is reimbursed only with restricted use, within its registered indication, but outside the restricted indication, is a special form of off-label use.
For example, biologicals were prescribed initially only in RA and therefore actual use of biologicals from a database would be a reliable estimate of the proportion of eligible patients for a BIA for new pharmaceuticals in this restricted indication.
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DILI remains the major adverse drug event that leads to termination of clinical development programs and regulatory actions including failure for marketing approval, restricted indications, and withdrawal from the marketplace.
8 14 28 29 Although the use of episiotomy is thus restricted, indications include rigid perineum and imminent perineal tear.
7 9 These have resulted in regulatory changes in countries such as the UK 10 and Australia involving restricted indications and addiction warnings on codeine-containing analgesic packets.
An update of national guidelines has been issued in 2008, further restricting indications to ventilation-tube placement and adenoidectomy in recurrent otitis [ 16], but strategies should be implemented for enhancing adherence among physicians, who could see guidelines both as a threat to their decisional autonomy [ 17] and as a cost-cutting tool for health care.
Therefore, the Food and Drug Administration has recently restricted the indication for panitumumab and cetuximab to wild-type KRAS mCRC patients.
In contrast, β-blockers were prescribed more likely if recommendations restricted their indication to the subgroup of patients with idiopathic dilated cardiomyopathy (Table 3).
Since the landmark publication in 1996 by Mazzaferro et al., many centres have restricted their indication for HCC-related LT due to clinical criteria based on tumour size and number ('Milan Criteria'), and other similar systems have since been used [ 21].
8 Concurrently, the European Medicines Agencies EMAA) Pharmacovigilance Risk Assessment Committee restricted the indications for hydroxyethyl starch and called for further studies evaluating the risk of complications in elective surgery and trauma patients.
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