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4/15/2011

Teva's Lansoprazole Tablets Can Clog Feeding Tubes, FDA Warns

Kate Traynor

Teva Pharmaceuticals has stopped distributing lansoprazole delayed-release orally disintegrating tablets because of dissolution problems causing clogs in feeding tubes and oral syringes, FDA announced Friday.

According to the agency, some patients have needed emergency care for the removal or replacement of feeding tubes that were clogged by incompletely dissolved lansoprazole that had been administered as a suspension. FDA stated that the tablets may not fully disintegrate or may disintegrate but later form clumps that can stick to the sides of oral syringes or feeding tubes.

The affected tablets were supplied as 15-mg unit dose blister packs and packs of three 10-tablet cards and as 30-mg unit dose blister packs and packs of five 6-tablet cards.

The tablets were packaged for Sharp Corporation, Cardinal Health, and Quality Packaging Specialist Inc., as well as Teva, FDA stated.

Although the tablets are no longer being distributed, FDA is concerned that pharmacies and patients may still have the material in their possession. The agency asked health care providers to check their medication stocks for the tablets and not dispense them to patients for administration through an oral syringe or feeding tube.

According to FDA, patients and caregivers who already have the tablets in their possession should not administer them through an oral syringe or feeding tube. Lansoprazole orally disintegrating tablets from a manufacturer other than Teva should be dispensed if the drug must be administered through such devices.

No problems have been reported with lansoprazole tablets that were administered orally without the use of feeding tubes or syringes, according to FDA.

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