FDA Warns of Stroke, Death With Off-Label Use of Wingspan Stent
Postmarket data show a significantly increased risk of stroke or death when the Wingspan intracranial stent system is used outside the approved indications. News Alerts
News Alert
Legacy Pharmaceutical Expands Losartan Recall
The repackaged lot was distributed nationwide and tied to a larger recall of losartan announced just days ago. News Alerts
FDA OKs Wearable Device for In-Home Monitoring of Vital Signs
The Current device, approved for use in hospitals, can now be used by patients with chronic conditions at home to help providers monitor vital signs and to prevent readmission. FDA Approvals
FDA Approves TransPyloric Shuttle Intragastric Device for Obesity
The endoscopically delivered intragastric device provides another option for patients who are obese but ineligible, or unwilling, to have bariatric surgery, and has advantages over intragastric balloons. FDA Approvals
Lotus Edge Gets FDA Approval for TAVR in High-risk Patients
This is the first repositionable and fully retrievable transcatheter aortic valve replacement device available in the United States. FDA Approvals
Mislabeled Fentanyl Patches Spark Nationwide Recall
Two lots of transdermal patches from the Fentanyl Transdermal System for pain management are being voluntarily recalled by the manufacturer because of product mislabeling. News Alerts
FDA Clears First Device for Treating ADHD
The US Food and Drug Administration has granted marketing authorization for the Monarch external trigeminal nerve stimulation system to treat ADHD in patients between the ages of 7 and 12 years. FDA Approvals
FDA Okays First Generic Naloxone Nasal Spray for Opioid Overdose
The FDA has granted final approval for the first generic naloxone hydrochloride nasal spray for reversing or stopping the effects from an opioid overdose. News Alerts
Torrent Recalls 104 More Lots of Tainted Losartan Tablets
The blood pressure tablets contain unacceptable levels of a potential carcinogen nitrosamine impurity that has prompted recalls by the company and other globally. News Alerts
FDA Clears Plenity Hydrogel Capsules for Weight Management
The FDA has cleared Gelesis100 for weight management in adults with a body mass index of 25 – 40 kg/m2, when used together with diet and exercise. FDA Approvals
EC Approves Olaparib for BRCA Breast Cancer
The European Commission has cleared olaparib (Lynparza, AstraZeneca/MSD) for the treatment of locally advanced or metastatic BRCA1/2 breast cancer. International Approvals
FDA Pulls All Vaginal Mesh Products Off the Market
The FDA said the manufacturers of vaginal mesh failed to provide reasonable assurance that the products are safe and effective. News Alerts
Temporary Shortage of Pediatric Tracheostomy Tubes: FDA
The closing of an ethylene oxide sterilization plant in Illinois has led to a temporary shortage of Bivona tracheostomy tubes manufactured by Smiths Medical. News Alerts
FDA Okays First Targeted Drug for Metastatic Bladder Cancer
Accelerated approval was granted to erdafitinib for treating locally advanced or metastatic bladder cancer with genetic alterations FGFR3 or FGFR2 after progressing on chemotherapy. A companion diagnostic was also approved. FDA Approvals
Duodenoscope Contamination Rates Still Lethally High: FDA
New data show ‘high-concern’ bacteria on 5.4% of properly reprocessed scopes; FDA reports three deaths in 2018 related to contaminated duodenoscopes. News Alerts
PRAC Restricts Use of Alemtuzumab for MS Pending Ongoing Review
The EMA committee recommends updating the product information to note the potential for acute immune-mediated conditions, stroke, cervicocephalic arterial dissection, and severe neutropenia. News Alerts
FDA Takes Action on Bogus Claims for DIY Concussion Devices
The FDA warns that unapproved medical devices and apps are being marketed to the public for concussion assessment without consultation with a healthcare provider. News Alerts
FDA OKs Romosozumab for Postmenopausal Osteoporosis
Romosozumab should be reserved for women at high risk for fracture who fail other therapies and should be avoided in women with a history of heart attack or stroke. FDA Approvals
Abrupt Discontinuation of Opioids Dangerous, FDA Warns
Opioid-dependent patients who suddenly stop the medication or rapidly decrease the dose may suffer serious withdrawal symptoms, uncontrolled pain, and psychological distress, the FDA reports. Medscape Medical News
FDA Clears New Drug-Sparing Option for HIV Infection
The dolutegravir and lamivudine combination (Dovato) is the first once-daily, single-tablet, two-drug regimen for adults with treatment-naive HIV infection. Medscape Medical News