Teva Acid Reflux Drug Problems Prompt FDA Warning

Generic <"">Lansoprazole, manufactured by Teva Pharmaceutical Industries Ltd., has been linked to reports of clogging problems. Reuters explained that the defective Lansoprazole is a generic acid reflux medication that is administered by either an oral syringe or a feeding tube.

In response to the reports it has received, the U.S. Food and Drug Administration (FDA) is recommending that patients who take the orally disintegrating tablet (ODT) form of Lansoprazole with oral syringes or feeding tubes stop taking this Teva version, wrote Reuters. Lansoprazole is a generic form of Takeda Pharmaceutical Co’s Prevacid. Prevacid, noted Reuters is part of a drug class called <"">proton pump inhibitors. Problems have not been reported in connection with the oral version of this medication.

Since the reports have surfaced, Teva has withdrawn its generic Lansoprazole from distribution; however, the FDA said on its website, that some of the defective medication might still be in pharmacies or facilities, or even in patients possession, wrote Reuters.

Teva’s generic Lansoprazole is meant to dissolve when added to water; however, the tablets might not completely dissolve or could form clumps that adhere inside oral syringes and feeding tubes, said Reuter. Some patients have required emergency medical treatment to unclog or remove and replace their medical devices, according to the FDA, which said it will continue its review and monitoring as well as Teva’s correction of the problem.

Prescription proton pump inhibitors currently on the market include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and AcipHex. Proton pump inhibitors are also sold as over-the-counter versions under the names Prilosec OTC, Zegerid OTC, and Prevacid 24HR. The drugs are approved to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

Proton pump inhibitors, which have become extremely popular, have been linked to a variety of other side effects. Recently, in fact, the FDA warned that taking the drugs over the long term could result in low serum magnesium levels (hypomagnesemia), which can cause serious health problems including muscle spasm, irregular heartbeat, and convulsions. The agency mandated that information about the potential risk of low magnesium be added to the WARNINGS AND PRECAUTIONS sections of the labels for all prescription proton pump inhibitors.

Last May, the agency also announced a label revision after it was found that long-term use of proton pump inhibitors, especially by women, could be associated with a long-term risk of certain fractures, including those involving the hip, wrist, and spine.

Most recently, we wrote the use of proton pump inhibitors in the first trimester of pregnancy could increase the chance that a baby will be born with a cardiac defect. In a 2010 retrospective study of over 200,000 women, those using proton pump inhibitors were twice as likely to have a child with a heart defect compared to those who did not take the drugs.

The study identified three types of birth defects: Septal defects, left ventricular defects, and right ventricular defects.

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