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INTUNIV (guanfacine), adrenergic alpha-agonist
PSYCHIATRY - New medicinal product
Opinions on drugs -
Posted on
Oct 04 2017
Reason for request
Inclusion
No clinical benefit demonstrated in the management of severe attention-deficit hyperactivity disorder in children and adolescents aged 6 to 17 years in case of inefficacy, intolerance or contraindication to methylphenidate.
- INTUNIV is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
- Its quantity of effect is modest compared with the placebo on the symptoms of ADHD and remains uncertain in patients for whom methylphenidate is not suitable, was not tolerated and/or was not effective, given the lack of robust data in this sub-population.
- Due to a concerning safety profile with, in particular, short-term neuropsychiatric and cardiovascular adverse effects and unknown long-term adverse effects, ongoing monitoring for the occurrence of adverse effects such as somnolence, sedation, hypotension, bradycardia, weight gain and suicidal ideation must be carried out during titration, as well as during continuation of treatment.
- This is a last intention treatment.
Clinical Benefit
| Low |
- |
Clinical Added Value
| no clinical added value |
- |
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