Recalls, Market Withdrawals, and Safety Alerts Important to GI
The FDA issued a safety communication titled “The FDA provides interim results of duodenoscope reprocessing studies conducted in real-world settings” to provide interim results from the ongoing mandated post-market surveillance studies (“522 study”) to inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after reprocessing.
The FDA warns that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC). To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label.
As a condition of approval, FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced PBC. These clinical trials are currently ongoing, and FDA expects to receive results in 2023. FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients with moderate to severe liver impairment more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death. FDA recommends that providers should follow the Ocaliva dosing regimen in the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage. Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death.
The FDA announcement cautions “patients and consumers” to use as directed by your health care professional. The alert aims to be curbing over-the-counter abuse. Many ACG members prescribe this for patients, but with consultation with the patient and medical literature. The FDA alert specifically says “patients and consumers should only take the dose of loperamide directed by your health care professionals or according to the OTC Drug Facts label, as taking more than prescribed or listed on the label can cause severe heart rhythm problems or death.”
In January 2017, Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. The validated manual reprocessing procedures for the ED-530XT duodenoscope outlined in December 2015 remain the same. Health care facilities should continue to use these validated instructions when reprocessing Fuji ED-530XT duodenoscope models. The validated reprocessing instructions when followed correctly, are intended to effectively clean and high-level disinfect the Fuji ED-530XT duodenoscope.
November 2, 2016
ACG note: FDA posts information on automated endoscope reprocessors
The FDA reports that it is reviewing critical factors that may contribute to infections associated with exposure to duodenoscopes and how they may be mitigated. Read the FDA information.
Patients who had hepatitis B in the past and are being treated with direct-acting antiviral drugs for hepatitis C are at risk of HBV reactivation, the FDA warns. The agency is mandating a black-box warning for the labels of at least nine branded DAA drugs about the risk due to 24 reported cases of HBV reactivation.
The FDA is notifying health care facilities of Custom Ultrasonics’ May 6, 2016 URGENT MEDICAL DEVICE RECALL, and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes. Based on the Agency’s February 2016 Safety Communication, at this time, facilities should have transitioned to alternative methods of reprocessing of duodenoscopes.
The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide (see Examples of Drugs that Can Potentially Interact with Loperamide).
Health care professionals should be aware that use of higher than recommended doses of loperamide can result in serious cardiac adverse events.
The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.
Consumers should always read the Drug Facts label carefully when purchasing or taking an OTC product to treat heartburn, acid indigestion, or sour or upset stomach. If the product contains aspirin, consider whether you should choose a product without aspirin to relieve your symptoms.