Orally disintegrating tablet (ODT) formulations of lansoprazole sold by Teva can be administered as a suspension through oral syringes and feeding tubes. However, the US Food and Drug Administration (FDA) has received reports the product has been associated with blocked tubes.
“[The] FDA is concerned about this issue and the potential for harm to patients”, said the agency, and “is seeking prompt correction of the problem by the manufacturer”. While this process is ongoing the FDA will continue to review and monitor the situation.
In a letter to healthcare professionals the FDA said the tablets may fail to fully disintegrate when added to water. Alternatively, the tablets may disintegrate fully but later aggregate into clumps.
Either scenario could lead to clumps sticking to the walls of oral syringes and feeding tubes. The FDA reports cases of patients needing emergency medical assistance. Unblocking, removal or replacement of feeding tubes has been required.
Teva has voluntarily withdrawn the product from distribution. The FDA is recommending healthcare professionals evaluate their medication stock and stop delivering lansoprazole delayed-release ODT formulations via an oral syringe or feeding tube.
Fewer than 10 per cent of patients take the product using oral syringes and feeding tubes, estimates Teva. No problems have been reported by patients taking the product by mouth.
The Teva-manufactured product may also be sold with labels from Sharp Corporation, Cardinal Health, and Quality Packaging Specialist, Inc.
FDA reviewing Teva NDA
Days before news of the voluntarily withdrawal it emerged the FDA has set a target date, November 14 2011, for completion of its review of the Bio-T-Gel new drug application (NDA) from Teva.
Bio-T-Gel, a treatment for low testosterone levels, was licensed from BioSante Pharmaceuticals by Teva. An NDA was filed in January 2011.
"We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched”, Stephen Simes, president & CEO of BioSante.