April 15, 2011
The U.S. Food and Drug Administration (FDA) is seeking help from healthcare professionals in communicating an important safety message about lansoprazole delayed-release orally disintegrating tablets (ODT), a generic prescription drug manufactured by Teva Pharmaceuticals, which may also be sold under the following labels: Sharp Corporation, Cardinal Health, and Quality Packaging Specialist, Inc.
The FDA has received reports that Teva’s lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices. The tablets may not fully disintegrate when water is added to them and/or they may disintegrate but later form clumps. These clumps can adhere to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced.
Lansoprazole is a proton pump inhibitor (PPI) medication. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).
FDA is concerned about this issue and the potential for harm to patients. Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some product may remain in stock in pharmacies and other facilities, and some patients may still have the product in their possession. To mitigate potential risks to patients, FDA recommends that healthcare professionals evaluate their medication stock and not dispense the Teva lansoprazole delayed-release ODT product to patients for whom the product will be administered through an oral syringe or feeding tube.
FDA recommends that these patients be dispensed a lansoprazole delayed-release ODT product from another manufacturer and be instructed to follow the specific directions in that product’s label for administration through an oral syringe or feeding tube.
Patients and caregivers should be instructed not to administer the Teva lansoprazole delayed-release ODT product through oral syringes and/or feeding tubes due to the potential for clogging and blockage of the oral syringe or tube. No problems have been reported with patients who take the product by mouth. Teva Pharmaceuticals estimates that less than 10% of the Teva lansoprazole delayed-release ODT product has been given through oral syringes and feeding tubes.
Patients and caregivers should be instructed that if they are unable to take the product orally, they should contact their healthcare professional to discuss replacement options so that they can maintain their drug regimen.
In general, patients and caregivers should be reminded to closely follow the directions contained in drug product labels when administering any drug product through an oral syringe or feeding tube.
Healthcare professionals, risk managers, and staff who purchase, stock, or administer lansoprazole, especially to patients with oral syringes and/or feeding tubes, should be alerted to this problem. [National Drug Code (NDC) numbers for the affected Teva products are listed in the attached appendix].
The agency asks that healthcare professionals and risk managers report any adverse events or problems experienced with lansoprazole delayed-release orally disintegrating tablets to FDA's MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
FDA is seeking prompt correction of the problem by the manufacturer and will continue to review and monitor the issue. The FDA will update the clinical community as new information of public health importance becomes available. Thank you for your help in communicating this important safety message.
The U.S. Food and Drug Administration
| Tablet, Delayed- |
|Lansoprazole||15 mg||Teva|| 30 tablets |
(3 cards of 10 tablets)
|Lansoprazole||15 mg||Teva||Unit dose blisters||0093-7448-19|
|Lansoprazole||30 mg||Teva|| |
(5 cards of 6 tablets)
|Lansoprazole||30 mg||Teva||Unit dose blisters||0093-7449-19|