Recalls, warnings, and alerts
A recall of certain lots of Medline Remedy Essentials No-Rinse Cleansing Foam (4- and 8-oz bottles) by Shadow Holdings (doing business as Bocchi Laboratories) due to the potential presence of Burkholderia cepacia complex. The CDC has reported 10 confirmed cases of B. cepacia in California (2), Pennsylvania (7), and New Jersey (1). Patients were already hospitalized for acute conditions and acquired the infections during hospitalization. The infections were linked to the Medline product, and the FDA recommends avoiding the use of all lots of this product. The agency continues to investigate to determine whether any additional products or lots may present health risks.
An alert of five additional deaths in patients with two liquid-filled intragastric balloon systems used to treat obesity. Since 2016, the FDA has received reports of 12 patient deaths involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System. The agency has approved labeling changes to reflect this information and continues to monitor deaths and other related complications, including perforation of the stomach wall or esophagus, acute pancreatitis, and spontaneous hyperinflation. The FDA continues to work with device manufacturers Apollo Endosurgery and ReShape Lifesciences to better understand the issue.
A recall of one lot of physician sample packs of the oral contraceptive norethindrone acetate and ethinyl estradiol and ferrous fumarate (TAYTULLA®) due to out-of-sequence capsules. A physician reported that four placebo capsules were placed out of order in a sample pack of the drug, with the first four days of therapy containing four placebo instead of active capsules. Affected products were distributed nationwide to clinicians and have an expiration date of May 2019.
A recall of one lot of fluticasone propionate nasal spray USP (50 mcg/spray) by Apotex Corp. due to the presence of small glass particles. The particles, discovered through a customer complaint, could block the actuator and impact the pump's functionality. Affected products were distributed nationwide to wholesalers and distributors and have an expiration date of July 2020.
Recommendations on using neurovascular stents for stent-assisted coiling to treat unruptured brain aneurysms. The FDA has received reports suggesting that using the devices for this purpose may be related to events of periprocedural stroke and/or death due to procedural risks or patient selection-related factors (e.g., serious comorbidities, intolerance to required anticoagulation or antiplatelet therapy). The agency issued a letter to clinicians with a complete list of recommendations for using neurovascular stents for stent-assisted coiling, such as discussing benefits and risks with patients.
Lofexidine hydrochloride (Lucemyra) to mitigate withdrawal symptoms and facilitate abrupt discontinuation of opioids in adults. The oral selective alpha 2-adrenergic receptor agonist is the first nonopioid treatment approved to manage opioid withdrawal symptoms, although it is not a treatment for opioid use disorder. The drug is approved for treatment for up to 14 days and may not completely prevent all withdrawal symptoms. In two randomized trials of 866 adults with opioid dependence who were abruptly discontinuing opioids, withdrawal symptom severity scores were lower in patients treated with the drug compared to placebo, and more patients who received the drug completed the treatment period compared to those who received placebo. The most common side effects include hypotension, bradycardia, somnolence, sedation, and dizziness. The drug was associated with a few cases of syncope, and it also affects the heart's electrical activity, potentially increasing the risk of abnormal heart rhythms. When patients discontinue the drug, they may experience a marked increase in blood pressure. The FDA is requiring 15 postmarketing studies to assess longer-term use and use in children.
The first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients. The FDA has permitted marketing for a new use of the BRUKER MALDI Biotyper CA system to identify the yeast species in addition to hundreds of other bacteria and yeast species of clinical relevance. The agency found that the system can reliably identify C. auris 100% of the time, although risks of the system include no identification or misidentification of a microorganism.