ENT-01 Safe, Improves Constipation in Patients With Parkinson Disease
Improvement seen in weekly complete spontaneous bowel movement rate and in secondary end points
Improvement seen in weekly complete spontaneous bowel movement rate and in secondary end points
The phase 3 trial included patients 6 to 17 years of age who fulfilled modified Rome III Criteria for child/adolescent functional constipation.
The marketing authorization was supported by data from a pivotal clinical trial in 312 patients with chronic idiopathic constipation.
Immunocompromised individuals may be at an increased risk for invasive infections if a contaminated product is consumed.
At this time, there have been no reports of adverse events related to this recall.
Improvement also seen in lipid metabolism, with increase in LDL cholesterol and decrease in HDL cholesterol
The recalled lot of Senna Syrup 8.8mg/5mL; NDC # 50268-731-24; Lot AM1115S; Expiration Date 01/2023, was distributed to the wholesaler, AvKare.
A significant percentage of affected patients were observed to have dilated atria and left ventricular hypertrophy.
Results showed that the majority of patients expressed dissatisfaction with the effect of the OTC agent on constipation and CIC-specific abdominal symptoms.
The product is administered as a split-dose regimen consisting of 2 doses.