Fw: FDA MedWatch - Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes

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From: FDA MedWatch <fda@...>

Subject: FDA MedWatch - Lansoprazole Delayed-Release Orally Disintegrating

Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged,

Blocked Oral Syringes and Feeding Tubes

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Date: Friday, April 15, 2011, 7:18 AM

FDA MedWatch - Lansoprazole Delayed-Release Orally Disintegrating Tablets by

Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral

Syringes and Feeding Tubes

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Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva

Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral

Syringes and Feeding Tubes

AUDIENCE: Risk Manager, Pharmacy, Home Care

ISSUE: 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.

BACKGROUND: 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).

Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release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. The product may also be sold under the following

labels: Sharp Corporation, Cardinal Health, and Quality Packaging Specialist,

Inc.

RECOMMENDATIONS:

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.

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.

Read the Healthcare Professional Letter for other specific recommendations and

for National Drug Code (NDC) numbers for the affected Teva products.

 

Healthcare professionals and patients are encouraged to report adverse events or

side effects related to the use of these products to the FDA's MedWatch Safety

Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax

to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Letter to Healthcare

Professionals, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm251575.htm

 

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