Teva Pharmaceutical Industries has withdrawn its version of a stomach-acid drug after the FDA notified doctors of potential safety problems. The disintegrating tablet form of lansoprazole, Teva's version of the Takeda acid reflux drug Prevacid ODT, may not dissolve properly, the agency said, citing reports of patients who had to get emergency medical aid because of clogged feeding tubes.
The ODT form is designed to dissolve in water for administration via oral syringe or feeding tube. But Teva's version can leave clumps on syringes and in feeding tubes, the FDA said. "FDA is concerned about this issue and the potential for harm to patients", the agency said in a letter to healthcare professionals, adding that it is working with Teva on "prompt correction of the problem." The faulty tablets may have also been distributed under three other brand names, the agency said.
No problems have been reported in patients who take Teva's dissolving tablets directly by mouth, the FDA said. The company estimates that fewer than 10 percent of patients use the product with oral syringes or feeding tubes.