Recalls and warnings
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 ofBurkholderia cepaciacomplex. The CDC has reported 10 confirmed cases of B. cepacia in California (n=2), Pennsylvania (n=7), and New Jersey (n=7). Affected 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. The agency continues to investigate to determine whether any additional products or lots may present health risks.
A recall of two lots of ampicillin and sulbactam for injection USP (3 g/single-dose vials) by AuroMedics Pharma due to the presence of particulate matter. The particulate matter identified in customer complaints is believed to be red rubber particles from the manufacturing process of the active ingredients.
A recall of two lots of piperacillin and tazobactam for injection USP (3.375 g/single-dose vials) by AuroMedics Pharma due to the presence of particulate matter. The particulate matter was confirmed to be glass, visible only after reconstitution.
A class I recall of Fabius anesthesia machines by Dräger Medical due to a production error. Excess oil was not removed at the time of production and can interfere with the position detector of the ventilation motor during operation, potentially causing ventilation to fail. The recall includes 62 devices distributed from July 14, 2017, to Dec. 13, 2017.
A class I recall of AirLife Resuscitation Device & Broselow Convenience Kits by Vyaire Medical due to an error in product design. The error may result in the inability to disconnect the mask component from the elbow of the resuscitator, potentially preventing necessary ventilation. The recall includes 357,581 devices distributed from March 2016 to January 2017.
Marketing of the Hemospray device to treat most types of upper or lower gastrointestinal (GI) bleeding. The aerosolized spray, which delivers a mineral blend to the bleeding site, is applied during an endoscopic procedure and can cover large areas, such as ulcers or tumors. In clinical studies of 228 patients and medical literature reports that included 522 patients, the device stopped GI bleeding in 95% of patients within five minutes of use. About 20% of patients experienced re-bleeding, usually within 72 hours but up to 30 days after device usage. About 1% of patients had one serious side effect, bowel perforation. The device is contraindicated in patients with GI fistulas and those at high risk of GI perforation. It is not intended to be used in patients with variceal bleeding.
The first test to identify the emerging pathogenCandida 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.
Dabrafenib (Tafinlar) and trametinib (Mekinist) to treat certain patients with anaplastic thyroid cancer. Administered together, the drugs are indicated to treat patients with unresectable or metastatic anaplastic thyroid cancer that is BRAF V600E mutation-positive. They were already approved, alone or in combination, to treat BRAF V600 mutation-positive metastatic melanoma and in combination to treat BRAF V600E mutation-positive metastatic non-small-cell lung cancer. In an open-label trial that evaluated the drug combination in 23 patients with BRAF V600E mutation-positive cancers, 57% had a partial reduction in tumor size and 4% had a complete response, with 64% of responders avoiding significant tumor growths for six months or longer. Common side effects of the drug combination include fever, rash, chills, headache, joint pain, cough, fatigue, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, hypertension, and dyspnea. Both drugs can cause harm to a developing fetus.
Lutetium Lu 177 dotatate (Lutathera) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The orphan drug is indicated for adults with somatostatin receptor-positive GEP-NETs and is the first radioactive drug approved to treat the rare group of digestive tract cancers. In a randomized clinical trial of 229 patients, those who received the drug in combination with octreotide had longer progression-free survival than those who took octreotide alone. In a second study, 16% of a sample of 360 patients who received the drug reported complete or partial shrinkage of their tumors. Common side effects include lymphopenia, high levels of enzymes in certain organs, vomiting, nausea, hyperglycemia, and hypokalemia. Serious side effects include myelosuppression, development of certain blood or bone marrow cancers, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility. It can also cause harm to a developing fetus.
New recommendations on using neurovascular stents for stentassisted coiling to treat unruptured brain aneurysms. The FDA has received reports suggesting that using the devices for this purpose may be related to 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). For patients with reduced life expectancy or with smaller brain aneurysms, the risks of treatment may outweigh the benefits. The agency issued a letter to clinicians with a complete list of recommendations for using neurovascular stents for stent-assisted coiling, including discussing benefits and risks with patients.