Recalls and warnings
A class I recall of BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits by Becton Dickinson CareFusion 303 Inc. due to the potential for stuck or unresponsive keys. There have been nearly 1,000 complaints about this issue but no reported injuries or deaths. The recall includes 264,746 devices distributed from Dec. 1, 2016, through Jan. 23, 2019.
A warning that using NSAIDs in the second half of pregnancy could lead to complications. The FDA is requiring labeling changes that explain that the medications may cause rare but serious kidney problems in an unborn baby if women take them about 20 weeks or later in their pregnancy. These kidney problems can lead to low levels of amniotic fluid (i.e., oligohydramnios) and the potential for pregnancy-related complications. Oligohydramnios may be detected after taking NSAIDs for days, weeks, or as soon as two days after starting regular use, the FDA said, adding that the condition usually resolves if the pregnant woman stops taking the drug.
A letter to clinicians warning about the potential risk of infection during cardiac surgery when using a CardioQuip Modular Cooler-Heater device. Three U.S. patients from one facility were infected with a species of nontuberculous Mycobacteria (NTM) called Mycobacterium abscessus after having cardiothoracic surgery involving use of the device. While the root causes of these infections are not known, all manufacturers of heater-cooler devices in the U.S. have now reported NTM patient infections, NTM device contamination, or both, the FDA said. The agency also provided recommendations on how clinicians and staff can reduce the risk of infection during cardiac surgery, including avoiding the use of tap water to rinse or fill heater-cooler water tanks.
Reissued emergency use authorization for certain filtering facepiece respirators that are manufactured in China and are not approved by the CDC's National Institute for Occupational Safety and Health. The reissued authorization no longer includes the three eligibility criteria that were included in the previous authorization letter, meaning the FDA will no longer review requests and add new respirator models to the list of authorized respirators based on those criteria. Authorization of respirator models that were already included on that list will continue.
A letter to clinicians recommending that they provide clear, step-by-step instructions to patients who are self-collecting anterior nasal samples for SARS-CoV-2 testing in a health care setting. Instructions should include the following: placing the entire tip of the swab inside the nose and using moderate pressure and a large circular motion to rub the side of the swab tip against as much of the wall of the anterior nares region as possible; performing at least four of these sweeping circles in each nostril using the same swab for about 10 to 15 seconds per nostril; and avoiding twirling the swab against one part of the inside of the nose or simply leaving the swab in the nose. Without proper instructions, patients may not collect an adequate sample for testing, potentially decreasing the sensitivity of the test, the FDA said.
Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) to treat Zaire ebolavirus, or Ebola virus, infection in adult and pediatric patients. The mixture of three monoclonal antibodies, which is the first FDA-approved treatment for Ebola virus, targets the glycoprotein that is on the surface of the virus. In a clinical trial of adult and pediatric patients with confirmed Ebola virus infection, 33.8% of 154 patients who received the drug died after 28 days, compared with 51% of 153 patients who received an investigational control. The most common side effects include fever, chills, tachycardia, tachypnea, and vomiting. Patients who receive the orphan drug should avoid the concurrent administration of a live vaccine due to the potential for reduced efficacy.
Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adults with malignant, unresectable pleural mesothelioma. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma. In a trial of 605 patients, those who received the drug combination survived a median of 18.1 months, and those who underwent chemotherapy survived a median of 14.1 months. The most common side effects include fatigue, musculoskeletal pain, rash, diarrhaea, dyspnea, nausea, decreased appetite, cough, and pruritus. The drug can also cause immune-mediated side effects.
First-time generic approvals
Potassium chloride in 0.45% and 0.9% sodium chloride injection USP as a source of water and electrolytes and 5% dextrose injection USP as a source of water, electrolytes, and calories. (Brand names: None provided)
Potassium chloride injection for the treatment of potassium deficiency states when oral replacement is not feasible. (Brand name: None provided)
Note: The FDA states that drugs are not always commercially available immediately after approval.