Generic Prevacid Dissolving Problems Lead to Market Withdrawal
April 18th, 2011 // 1:52 pm @ jmpickett
Federal regulators are warning that a generic version of the heart burn drug Prevacid, which is supposed to dissolve when suspended in liquid, may clog feeding tubes and oral syringes because it is failing to dissolve properly. The drug has been withdrawn from the market, but hospitals and pharmacies are not being asked to return the drug.
The generic lansoprazole recall was announced in a letter to healthcare professionals sent out on April 15 by the FDA after reports that the pills had clogged and jammed medical equipment despite being designed to orally disintegrate.
The FDA reported that in some cases patients have required emergency care because their feeding tubes were clogged by clumps of the pills. The lansoprazole pills, manufactured by Teva Pharmaceuticals, are a generic version of Prevacid, which is manufactured by Takeda Pharmaceuticals.
According to the FDA, the tablets are only dissolving partially, or they are later forming clumps that can clog up medical devices and cause an emergency situation for some patients. The drug is a proton pump inhibitor (PPI) approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome.
The FDA warned that despite the recall by Teva, some hospitals may still have the drug in stock. The agency warned health care professionals to use another generic version of the drug that was designed to orally disintegrate if they have patients who require the drug be administered via a feeding tube.
The drug recall affects all lansoprazole delayed-release orally disintegrating tablets (ODT) 15mg strength by Teva Pharmaceuticals. The affected products include packages of 30 tablets with NDC number 009-7448-65 and 0093-7449-65, and unit dose blisters with NDC number 0093-7448-19 and 0093-7449-19. The drugs may also be sold under the Sharp Corporation, Cardinal Health and Quality Packaging Specialist, Inc. labels.
While Teva has withdrawn the drug from the market at this time, the FDA said it was safe to give to patients as long as they actually could let the pill dissolve in their mouths. According to Teva, less than 10% of all doses of its lansoprazole delayed-release ODT pills are given via feeding tubes or oral syringes.
The FDA said in its letter that it is waiting for Teva to correct the problem and is continuing to watch the situation. The FDA requests that doctors and patients report any problems associated with the drug to the FDA MedWatch adverse event reporting program.
