The U.S. government is warning doctors to stop using Enteryx, an injection used to treat acid reflux disease, saying it has been connected to serious health problems and, in at least one case, a death.
Many of the problems with Enteryx have occurred when it is injected imprecisely, missing its intended destination and passing through the wall of the esophagus, sometimes entering other internal organs or the bloodstream, risking blockage of blood vessels, the Food and Drug Administration said. Doctors have not always immediately detected a faulty injection.
Enteryx is injected as a liquid that solidifies into a spongy material that cannot be removed. When it is injected properly, it strengthens the lower esophagus, helping prevent stomach acid from entering it and causing pain.
The FDA did not provide specific numbers on the number of problems that have been discovered. Manufacturer Boston Scientific Corp. issued a recall on Sept. 23 but blamed the problems entirely on faulty injection technique.
The FDA also cited at least two instances in which Enteryx was injected properly but patients still developed problems. The death was blamed on Enteryx being injected into the wall of the aorta.
The FDA said people who received the injection and are suffering from chest, stomach or side pain, flu-like symptoms, including fever, cough or shortness of breath, or fainting spells should contact their doctor immediately.
Boston Scientific is advising people who have received an Enteryx injection in the last 30 days to see their doctor for a follow-up, but the FDA said some problems associated with the injection have occurred seven weeks later, AP reports.