FDA Warns Doctors On Teva’s Generic Prevacid SoluTabs
April 18th, 2011 // 1:27 pm @ jmpickett
The U.S. Food and Drug Administration is warning that a dissolvable generic heartburn drug made by Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) may clump and cause problems for patients using an oral syringe or feeding tube.
The drug is a generic form of Prevacid SoluTabs, sold by the Japanese drug maker Takeda Pharmaceutical Co. Ltd. (TKPYY, 4502.TO). It reduces stomach acid and is used to treat problems including certain types of stomach ulcers and gastrointestinal reflux disease.
In a letter to physicians, the FDA said Teva’s product may not fully disintegrate when water is added and/or may disintegrate but later form clumps. The clumps can adhere to the inside walls of oral syringes and feeding tubes, and agency has gotten reports of the drug clogging and blocking the delivery systems.
In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced, the agency said.
It recommends against using the drug for this use and said health-care professionals should evaluate their inventory.
Teva officials weren’t immediately available for comment.
The FDA said the company has “voluntarily withdrawn” the product from distribution, although some may remain in stock in pharmacies and other facilities, and could still be in the hands of patients.
The drug may be sold under the following labels: Sharp Corporation, Cardinal Health and Quality Packaging Specialist Inc., the FDA said.
The FDA said that no problems have been reported with taking the drug by mouth. It said that Teva estimates that less than 10% of the product has been given through oral syringes and feeding tubes.
