A FDA (entidade que regula os medicamentos nos EUA) advertiu sobre relatos de infecções oculares relacionadas ao uso de determinados lotes de Avastin.
FDA warns of eye infection reports with compounded Avastin
By: Joe Barber
The FDA on Wednesday warned about reports of eye infections linked to a recall of unapproved syringes of Roche’s Avastin (bevacizumab) made by a Georgia compounding pharmacy for the treatment of macular degeneration. “The product has or potentially could result in an infection within the eye,” federal regulators said.
Earlier this week, compounding pharmacy Clinical Specialties recalled approximately 40 lots of Avastin syringes after receiving five reports of bacterial endophthalmitis due to infection by streptococcus bacteria. The repackaged product was distributed to doctors’ offices in Georgia, Louisiana, South Carolina and Indiana from December 18 until the present.
Roche’s Genentech unit has long warned against the unapproved use of Avastin for macular degeneration and markets the FDA-approved Lucentis (ranibizumab) specifically for the condition. However, the American Academy of Ophthalmologists and other groups assert that there is no difference in patient outcomes between those given Avastin and those given Lucentis. Repackaged injections of Avastin cost approximately $50, compared with more than $1000 for Lucentis.
In 2011, the FDA warned about a cluster of serious eye infections in Florida linked to Avastin syringes compounded by a pharmacy in that state. In some cases, the infections caused permanent blindness in patients.
(Ref: The Washington Post, The Wall Street Journal, NBC News, FDA)
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