AprÃ¨s les anti-VEGF, et alors que nous l’utilisons couramment (cependant toujours hors AMM) depuis plusieurs annÃ©es, avec de nombreuses publications Ã l’appui, la FDA vient de publier une alerte sur la toxicitÃ©
de la triamcinolone d’un conservateur dans la prÃ©paration commerciale de triamcinolone (Kenalog), et dÃ©conseille son usage « off-label » :
February 7, 2007 â€” The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for […] toxicity associated with excessive exposure to the preservative in triamcinolone acetonide injectable suspension […]
On November 20, 2006, the FDA approved safety labeling revisions for triamcinolone acetonide 10- and 40-mg/mL injectable suspension (Kenalog-10 and Kenalog-40, made by Apothecon, Inc, [a Bristol-Myers Squibb company]) to advise users about the toxicity associated with excessive exposure to the preservative used in these products, […], and to advise against the use of off-label administration methods.
Each milliliter of triamcinolone 10-mg/mL injectable suspension contains 0.9% (weight/volume) benzyl alcohol as a preservative. The 40-mg/mL formulation contains 0.99% (weight/volume) of the agent.
Triamcinolone 10-mg/mL injection is intended for intra-articular and intralesional administration; the 40-mg/mL formulation may be given by intramuscular or intra-articular routes.
According to the FDA, the safety of […] subconjunctival, subtenons, retrobulbar, and intravitreal injections have not been evaluated. However, intravitreal injection of triamcinolone has been linked to reports of endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances, including vision loss. Also, several instances of blindness have been reported following injection of corticosteroid suspensions into the nasal turbinates and intralesional injection about the head. Administration of triamcinolone injection by these routes is therefore not recommended.