Recalls and warnings
A class I recall of the SAPIEN 3 Ultra Delivery System by Edwards Lifesciences, LLC, due to bursting balloons during surgery. The device is used to deliver and deploy a transcatheter heart valve to replace a diseased aortic valve without open-heart surgery. The issue has resulted in difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or surgical intervention. As of July, 17 related injuries and one death were reported. The recall includes 1,585 devices distributed from Jan. 3 to the present.
A warning that palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio), used to treat some patients with advanced breast cancer, may cause rare but severe inflammation of the lungs. The overall benefit of the cyclin-dependent kinase 4/6 inhibitor medicines is still greater than the risks when used as prescribed, the FDA said. Clinicians should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. They should interrupt the drugs in patients who have new or worsening respiratory symptoms and should permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis.
A safety communication about incidents of severe respiratory disease that appear to be associated with the use of e-cigarette/vaping products. As of Oct. 22, there were 1,604 vaping-related lung injury cases reported from 49 states (all except Alaska), the District of Columbia, and the U.S. Virgin Islands, and 34 deaths have been confirmed in 24 states, according to the CDC. In many cases, patients reported a gradual start of symptoms, including breathing difficulty, shortness of breath, and/or chest pain before hospitalization. Some reported mild to moderate gastrointestinal (GI) illness, including vomiting, diarrhea, and other symptoms such as fever or fatigue. Most of the people in this outbreak reported using tetrahydrocannabinol (THC)-containing products, or both THC-containing products and nicotine-containing products. The FDA has warned the public to stop using THC-containing vaping products and any vaping products obtained on the street. The FDA has also warned JUUL Labs, Inc., for marketing unauthorized modified-risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. In September, the vape brand suspended broadcast, digital, and print advertising in the U.S. In October, it suspended the sale of some of its flavored products.
A drug safety communication that hepatitis C medicines have led to rare cases of worsening liver function or liver failure in some patients. The FDA has identified 63 cases of liver decompensation with the use of glecaprevir/pibrentasvir (Mavyret), elbasvir/grazoprevir (Zepatier), or sofosbuvir/velpatasvir (Vosevi) to treat hepatitis C, most of which occurred in patients with moderate to severe liver impairment who should not have been prescribed these medicines. Some of the cases led to liver failure and death. The medications are FDA-approved to treat chronic hepa titis C in patients with out liver impairment or with mild liver impairment (Child-Pugh A). The FDA recommended that clinicians continue to prescribe the drugs as indicated, assess severity of liver disease at baseline, closely monitor for signs and symptoms of worsening liver function, and discontinue the drugs in patients with signs and symptoms of liver decompensation or as clinically indicated.
Semaglutide (Rybelsus) oral tablets to improve control of blood glucose in adults with type 2 diabetes, along with diet and exercise. The drug is the first noninjection glucagon-like peptide (GLP-1) receptor agonist approved in the U.S. Its efficacy and safety were studied in two placebo-controlled trials and several trials that compared it to other GLP-1 injection treatments. In the placebo-controlled studies, the drug as a standalone treatment resulted in a significant reduction in HbA1c levels compared to placebo. After 26 weeks, 69% of participants taking 7 mg/d and 77% of those taking 14 mg/d had an HbA1c below 7%, compared with 31% of those on placebo. A boxed warning advises clinicians about a potential increased risk of thyroid C-cell tumors and the fact that the drug is not recommended as the first choice of medicine to treat diabetes. It should not be used in patients who have a personal or family history of medullary thyroid carcinoma or in those who have had multiple endocrine neoplasia syndrome type 2. The drug also carries warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
Glecaprevir and pibrentasvir (Mavyret) tablets for an eight-week treatment duration for adults and children ages 12 years and older or weighing at least 99 pounds with chronic hepatitis C virus (HCV) infection. The regimen is the first eight-week treatment approved for all treatment-naive adult and certain pediatric patients who have chronic HCV genotypes 1 through 6 infection and compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more. Across clinical trials of the regimen for durations of eight, 12, and 16 weeks, sustained virologic response ranged from 91% to 100%. The most common adverse reactions are headache and fatigue. The treatment is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C), those with any history of liver decompensation, and those taking the drugs atazanavir and rifampin.