Post-marketing surveillance study finds FDGard an effective and well-tolerated remedy

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Post-marketing surveillance study finds FDGard an effective and well-tolerated remedy

By Michael Johnsen - 08/24/2017

BOCA RATON, Fla. — IM HealthScience on Thursday announced favorable results from its Functional Dyspepsia Safety Update at 12 months, a real-world, post-marketing surveillance study reporting on the safety and tolerability profile of FDgard among an estimated 392,554 patients who used the product.



"Functional dyspepsia can have a significant impact on one's quality of life," stated Michael Epstein, a leading gastroenterologist and chief medical advisor for IM HealthScience. "The findings from FDSU-12 reaffirm the safety and tolerability profile of FDgard in real-world settings and are very reassuring. FDgard is an effective and well-tolerated option in the management of patients with FD where few options are available."



The results found no serious adverse events. Additionally, the rates and patterns of non-serious adverse events were low (0.014% or 57 people out of 392,554 patients studied) and generally consistent with those normal adverse events commonly associated with an FD population. These non-serious adverse events included dyspepsia, rash, headache and abdominal pain.



The FDSU-12 captured and analyzed serious and non-serious adverse event reports for FDgard over a twelve-month period from July 8, 2016, to July 8, 2017.



FDgard is a non-prescription medical food specially formulated for the dietary management of Functional Dyspepsia. FD is often characterized as persistent or recurring indigestion with no known organic cause.  Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.  Currently, there are no approved drugs for FD and off-label medications are used to treat the condition.  



 


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