Allergan has decided to recall seven batches of Ozurdex eye implants from the Indian market after a silicone particle of around 300 microns in diameter was observed in “dispensed implants”. Moreover, Allergan has advised the doctors to use alternative treatments “until unaffected product is available” in India.
“Based on the information provided by Allergan India Private Limited to the Drugs Controller General India (DCGI) office and further evaluation and their instructions, we are going to recall all affected lots/batches of Ozurdex from the distribution channel up to retail and hospital level. A separate communication is being sent to the hospital providing details of the recall process,” stated Ammar Raza, country medical director, Allergan India, in a letter to doctors dated October 12, 2018.
Ozurdex is a biodegradable implant that is injected into the eye to treat patients suffering from diseases such as macular edema and uveitis. During a routine in-process inspection, Allergan found a loose particle of silicone on a “sampling of Ozurdex implants”. This silicone particle was released into the drug from the needle sleeve, which is part of the plunger of the injection.
Raza stated in his letter that a “silicone particle of approximately 300 microns in diameter was observed in dispensed in Ozurdex implants”.
He added: “Subsequent testing of retained samples has identified that batches already distributed in the EU (European Union)/ other parts of the world including India are affected.”
Raza also stated: “The risks associated with the injection of silicone along with the Ozurdex implant cannot be precisely ascertained due to lack of adequate information. Likewise, experience with other silicone substances injected into the eye cannot be directly extrapolated to this scenario. The possible theoretical adverse events with the silicone particle are listed below: obscuration of vision by particle; intraocular inflammation; corneal adverse reaction.”
Allergan India did not respond to the queries sent by The Indian Express. Vitreo-Retina Society of India (VRSI) — an organisation of more than 300 Vitreo-Retina specialists in India — has issued an advisory stating that the doctors should not use Ozurdex “until further clarification”. VRSI did not respond to the queries sent by The Indian Express. Raza stated in his October 12 letter that batches of Ozurdex already distributed in India are affected by the defect. “Generally, most batches have 2 per cent to 4 per cent of defective units, but defect rates as high as 22 per cent have been reported,” he added.
Raza mentioned that new stocks of Ozurdex “that are reliably known to be free of this defect” will be made available in India but until unaffected product is available, “clinicians are advised to consider alternative treatments”. He added that Allergan has identified a corrective action that eliminates creation of the particle and is “working quickly to implement this action prior to releasing any further product in agreement with the Irish Health Agency”. Allergan’s headquarters are situated in Dublin, Ireland.