Summary Safety Review - INTUNIV XR (guanfacine hydrochloride) - Assessing the Potential Risk of Raynaud's Phenomenon

A safety review was carried out to evaluate the potential risk of Raynaud's phenomenon in patients taking Intuniv XR. Raynaud's phenomenon is a disorder of the blood vessels, mainly in the fingers and toes, where they episodically do not receive enough blood and oxygen. The resulting lack of blood and oxygen causes numbness and the skin will turn a pale or bluish colour. Most episodes of this phenomenon last about 15 minutes but in severe cases this can cause damage to the skin and muscle (through oxygen deprivation and tissue death). Health Canada started a review because other drugs used to treat ADHD contain warnings in their product safety information about the risk of Raynaud's phenomenon. The review aimed to determine whether there was enough evidence to include a similar stronger warning for Intuniv XR.

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Title (French)	Résumé de l'examen de l'innocuité - INTUNIV XR (chlorhydrate de guanfacine) - Évaluation du risque potentiel de phénomène de Raynaud
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Open Canada Date Published	2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["Examen sommaire de l'innocuité", "INTUNIV XR", "chlorhydrate de guanfacine", "évaluation", "risque potentiel", "phénomène de Raynaud", "trouble des vaisseaux sanguins", "des doigts et des orteils", "suffisamment de sang et d'oxygène", "manque de sang et d'oxygène", "peau pâle", "peau de couleur bleuâtre", "causer des dommages à la peau et aux muscles", "une privation d'oxygène", "la mort des tissus"], "en": ["Summary Safety Review", "INTUNIV XR", "guanfacine hydrochloride", "assessing", "potential risk", "Raynaud's Phenomenon", "disorder of the blood vessels", "fingers and toes", "enough blood-and-oxygen", "lack of blood-and-oxygen", "pale skin", "bluish colour skin", "cause damage", "skin and muscle", "oxygen deprivation", "tissue death"]}
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