Compared to placebo, the drug significantly reduced symptoms in a randomized controlled trial of 264 adults with travelers' diarrhea in Guatemala and Mexico.
The device delivers a mineral blend to sites of upper or lower GI bleeding and is applied during an endoscopic procedure.
More patient deaths associated with intragastric balloon weight-loss systems | ACP Gastroenterology Monthly
Clinicians should closely monitor patients with intragastric balloons for complications and explain symptoms that could be signs of serious or life-threatening problems, the FDA advised.
Drug cleared to treat moderately to severely active ulcerative colitis | ACP Gastroenterology Monthly
It is the first oral medication to be approved for chronic use in this population.
The FDA had requested validation testing data from all companies that have automated endoscope reprocessors labeled to reprocess endoscopes because of the potential association with patient infection.
One lot of pantoprazole sodium for injection (40 mg per vial) was recalled in December.
The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.
First drug approved to treat thrombocytopenia in adults with chronic liver disease who are having a medical procedure | ACP Gastroenterology Monthly
Patients who received the drug for five days had increased platelet counts compared to those taking placebo.
ACP Gastroenterology Monthly delivers a monthly summary of news in gastroenterology and hepatology, including the latest research, clinical guidelines, and FDA drug actions.
The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, the FDA said.