Serious Adverse Events Linked to Enteryx Use |
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The FDA and Boston Scientific notified patients and healthcare professionals about serious adverse events, including death, occurring in patients treated with Enteryx, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease.
The serious adverse events involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution.
Physicians should immediately stop injecting Enteryx into patients and follow the manufacturer’s procedures for returning unused product. The FDA also provided recommendations on avoiding future occurrences and advice for patients.
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Other Drugs / Medical Cases of Interest
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