Overheated [feeling hot]; sweating all over body [hyperhidrosis]; heart began to race [palpitations].Case description: this serious regulatory authority, spontaneous report was received from a consumer in united states via the us fda.This report concerns a consumer of unknown gender and age who experienced overheating, sweating all over body and heart began to race during treatment with euflexxa (sodium hyaluronate) solution for injection 1 %, 3 injections, 1 week apart, for osteoarthritis in 2016.The patient reported that within a half hour after the second and third injections of eufelxxa the patient became severely overheated and began sweating all over the body.The patient reported that about an hour or so after the injections the heart began to race excessively and continued to race for several hours.After about 16 hours, these symptoms completely resolved.The sweating all over body, overheated and heart began to race was medically significant.Action taken to euflexxa was dose not changed.The outcome of overheated, sweating all over body and heart began to race was recovered.The following concomitant medication was reported: novolog, minoxidil, turmeric curcumin, hydrochlorothiazide, furosemide, diltiazem, carvedilol, clonidine, omega 3, aspirin, simvastatin, nitroglycerine, losartan, buspirone, vitamin d3, paroxetine hcl, levemir, bilberry, iron, metformin.At the time of reporting, the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related; company causality: related.Other case numbers: fda device report number = mw5059645.Sender comment: in light of the negative rechalllenge, it is not likely that the events reported are caused by euflexxa it self, but it cannot be ruled out that the initial injection procedure might have triggered the events.
|