FDA Update
Sickle cell drug withdrawn from market
The FDA recently announced that voxelotor was being removed from the market, along with several ventilator- and pump-related recalls, among other actions.
FDA approves self-administration of nasal flu vaccine
The FDA announced that the nasal spray vaccine may now be administered by patients and caregivers, among other recent actions. A prescription is still required.
Updated COVID-19 vaccines approved
The FDA also authorized marketing of a molecular-based assay to detect colonization with Candida auris, among other recent actions.
Point-of-care HCV test, Alzheimer's drug approved
The newly approved test detects hepatitis C virus (HCV) RNA and delivers results in about an hour using a blood sample from the fingertip.
RSV vaccine news, Entresto generic approval
The respiratory syncytial virus (RSV) vaccine by Moderna was newly approved for patients ages 60 years and older, while approval of the GlaxoSmithKline vaccine was expanded to ages 50 to 59 years, among other recent actions by the FDA.
New sepsis risk calculator that uses AI approved
The FDA approved an artificial intelligence (AI) program that identifies patients at risk for sepsis and a higher-dose naloxone spray, among other actions.
Antibiotic OKed for pneumonia, bloodstream, skin infections
In addition to approving ceftobiprole medocaril sodium for three different types of infection, the FDA authorized the first generic version of fidaxomicin, among other actions.
First medication for severe frostbite approved
The FDA also warned about smartwatches claiming to measure blood sugar without piercing the skin, among other recent actions.
Genetic test for opioid disorder risk approved
The new test is to be used prior to patients' first exposure to oral opioids for the treatment of acute pain. Other recent FDA actions include a recall of overly potent IV drugs.
New sickle cell therapies approved
The FDA also warned about eye infections with over-the-counter drops and skin reactions to antiseizure medications, among other actions.
Surgical devices, ventilators, dialysis machines recalled
The FDA also approved first-time generics for spironolactone oral suspension and calcium gluconate, among other actions.
New COVID-19 boosters, biosimilar for MS OK’ed
The FDA approved updated COVID-19 vaccines and the first-ever biosimilar for multiple sclerosis (MS), among other recent actions.
FDA provides info on stimulant shortage
Also, a sterilizer for 3D-printed medical devices, a drug for postpartum depression, and an RSV vaccine for pregnant patients were approved, among other recent FDA actions.
Catheters recalled; warning on troponin tests
The FDA announced a recall of certain peripheral catheters due to leaking and warned not to use a cardiac testing panel providing inaccurate troponin measurements, among other recent actions.
New antibiotic approved for hospital-acquired pneumonia
The FDA approved sulbactam and durlobactam for injection to treat hospital-acquired or ventilator-associated pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex, among other recent actions.
RSV vaccine, OTC naloxone approved
The FDA also updated the prescribing information for immediate-release opioid pain medicines to note that these products should not be used for an extended period, among other recent actions.
Over-the-counter test for flu, COVID-19 authorized
The FDA also approved albuterol and budesonide inhalation aerosol, the first combination of an inhaled corticosteroid and a short-acting beta-agonist for asthma, among other recent actions.
Tocilizumab approved for COVID-19
The FDA gave full approval to tocilizumab for adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, among other actions.
New drugs for C. diff, type 1 diabetes
The FDA recently approved the first fecal microbiota product for preventing Clostridioides difficile recurrence and an injection to delay progression of type 1 diabetes, among other actions.
Tracheostomy tube shortage
The FDA alerted clinicians about the need to reuse tracheostomy tubes and to caution patients about decreased effectiveness of pre-exposure prophylaxis against COVID-19, among other recent actions.
BiPAP masks recalled for magnetic interference
The FDA reported safety concerns with masks for some bilevel positive airway pressure (BiPAP) machines and approved the first generic version of a popular diabetes drug, among other recent actions.
Fecal transplants could transmit monkeypox
The FDA recently advised that donated stool should be screened for monkeypox before transplantation and authorized updated booster vaccines against COVID-19, among other actions.
Monkeypox update, new breast cancer type and treatment
In addition to providing an update on efforts to combat monkeypox, the FDA recently approved an infusion drug for HER2-low breast cancer and generic versions of atropine, electrolytes, and other drugs.
Advisors discuss vaccines for fall, COVID-19/RSV/flu test approved
In addition to COVID-19-related actions, the FDA announced several device recalls and approved a drug for eosinophilic esophagitis.
Enteral tubes, insulin recalled
The FDA also recently approved a first-in-class type 2 diabetes drug and generic versions of sodium phosphate injections, lactated Ringer's with 5% dextrose injections, dapagliflozin, and digoxin tablets.
New heart failure indication for SGLT-2 inhibitor
In addition to approving a sodium-glucose cotransporter-2 (SGLT-2) inhibitor for use in heart failure with preserved ejection fraction, the FDA recently warned about certain ventilators failing and a possible risk of cancer with a lymphoma medication.
EUAs revised for convalescent plasma, monoclonals, vaccines
In addition to the emergency use authorization (EUA) changes, recent FDA actions include a notification that some patients have had false-positive test results for syphilis after COVID-19 vaccination. The agency also approved a new antiviral to treat post-transplant cytomegalovirus infection and several newly generic drugs.
New devices for congenital heart disease, multiple sclerosis
Recalls, alerts, and approvals.
Ranitidine pulled from market due to contamination
Details on recalls, withdrawals, and approvals.
New warnings for gabapentinoids; generic apixaban approved
Details on the latest alerts, recalls, and approvals.
New antibiotic, report on drug shortages
Details on the latest alerts, recalls, and approvals.
Safety communication about hacking of hospital devices, networks
Details on the latest alerts, recalls, and approvals.
Safety communication about hacking of hospital devices, networks
Details on the latest alerts, recalls, and approvals.
Pulmonary illnesses linked to e-cigarettes
Details on the latest recalls, warnings, and approvals.
New device for advanced heart failure
Details on the latest alerts, recalls, and approvals.
Nasal powder for severe hypoglycemia, generic pregabalin approved
Details on the latest alerts, recalls, and approvals.
Insomnia meds get boxed warning; pacemakers prematurely losing power
Details on the latest alerts, recalls, and approvals.
Ventilator recall, generic naloxone approval
Details on the latest alerts, recalls, and approvals.
FDA analyzing mortality risk with paclitaxel-coated balloons, stents
Details on the latest alerts, recalls, and approvals.
Defibrillators and more ARBs recalled
Details on the latest alerts, recalls, and approvals.
Recalls continue for hypertension meds
Details on the latest alerts, recalls, and approvals.
New cardiac warning for fluoroquinolones
Details on the latest alerts, recalls, and approvals.
More recalls, info on impurity found in ARBs
Details on the latest alerts, recalls, and approvals.
New warning on SGLT2 inhibitors
Details on the latest recalls, warnings, and approvals.
EpiPen gets new expiration date, generic version
Details on the latest recalls, warnings, and approvals.
New warnings for fluoroquinolones
Details on the latest recalls, warnings, and approvals.
Patient deaths linked to weight-loss device
Details on the latest recalls, warnings, and approvals.
Hospital infections linked to foam cleanser
Details on the latest recalls, warnings, and approvals.
Warning about immune reaction to seizure drug
Details on the latest recalls, warnings, and approvals.
FDA warns about clarithromycin in heart disease
Details on the latest recalls, alerts, and approvals.
New artificial intelligence app identifies strokes
Details on the latest recalls, alerts, and approvals.
Warning on pneumothorax with enteral access system
Details on the latest recalls, alerts, and approvals.
Triclosan banned from health care antiseptics
Details on the latest recalls, alerts, and approvals.
Newly approved drug has a digital adherence tracker
Details on the latest warnings, recalls, and approvals.
Co-prescription acceptable for opioid addiction meds and benzodiazepines
Details on the latest warnings, recalls, and approvals.
Bariatric surgery device linked to deaths
Details on the latest warnings, recalls, and approvals.
Large recall of sodium bicarbonate and other injectables
Details on the latest warnings, recalls, and approvals.
Manufacturer asked to remove opioid from market
Details on the latest warnings, recalls, and approvals.
New drug treats cancer based on biomarker instead of location
Details on the latest warnings, recalls, and approvals.
EpiPens recalled, MS drug approved
Details on the latest warnings, recalls, and approvals.
Infectious disease tests gain new approvals
Details on the latest warnings, recalls, and approvals.
Allergic reactions to chlorhexidine; new drug for plaque psoriasis
Details on the latest warnings, recalls, and approvals.
Warning on risk of hacking with cardiac devices
Details on the latest warnings, recalls, and approvals.
One diabetes drug gets new indication, another gets new warning labeling
Details on the latest recalls, warnings, and approvals.
New device for strokes due to PFO
Details on the latest recalls, warnings, and approvals.
Warning about HBV reactivation with HCV drugs
Details on the latest recalls, warnings, and approvals.
New warnings against mixing opioids and benzos
Details on the latest recalls, warnings, and approvals.
Updated warnings on fluoroquinolones, new diabetes drug approved
Details on the latest recalls, warnings, and approvals.
Docusate recalled, test for CRE approved
Details on the latest recalls, warnings, and approvals.
New concerns about diabetes drugs, migraine patches
Details on the latest safety notices, warnings, and approvals.
New warning about fluoroquinolones
Details on the latest recalls, warnings, and approvals.
Opioids and diabetes drugs get revised warnings
Details on the latest recalls, warnings, and approvals.
New hemophilia drug, powdered glove ban
Details on the latest recalls, warnings, and approvals.
Central lines, IV solutions, test strips recalled
Details on the latest recalls, warnings, and approvals.
Warning about posaconazole formulation confusion
Details on the latest recalls, warnings, and approvals.
SGLT2 inhibitors get new warning, rosiglitazone gets off REMS
Details on the latest recalls, warnings, and approvals.
Warning on infections associated with heater-cooler devices
Details on the latest recalls, warnings, and approvals.
Dabigatran reversal agent approved
Details on the latest recalls, warnings, and approvals.
New warnings on multiple diabetes drugs
Details on the latest recalls, warnings, and approvals.
New cholesterol drug class; FDA investigates gadolinium
Details on the latest recalls, warnings, and approvals.
Warning on NSAIDs strengthened and new schizophrenia drug approved
Details on the latest recalls, warnings, and approvals.
Ventilators, patch, and injections recalled
Details on the latest recalls, warnings, and approvals.
FDA approves heart failure drug and looks into antiseptic safety
Details on the latest recalls, warnings, and approvals.
Warning on using hep C drugs with amiodarone; gastroparesis test approved
Details on the latest recalls, warnings, and approvals.
New antifungal for aspergillosis and mucormycosis approved
Details on the latest recalls, warnings, and approvals.
Approvals for an oral anticoagulant, weight-loss device, and generic esomeprazole
Details on the latest recalls, warnings, and approvals.
New antiviral, antibiotic approved
Details on the latest recalls, warnings, and approvals.
Warnings about long-term dual antiplatelet therapy, gram-negative tests
Details on the latest recalls, warnings, and approvals.
Meningitis vaccine, combination hepatitis C pill, and glucose meter for critically ill approved
Details on the latest recalls and approvals.
New tests for acute kidney injury and yeast bloodstream infections
Details on the latest recalls, label changes, and approvals.
New types of insomnia medication, colorectal screening approved
Details on the latest recalls and approvals.
New skin antibiotic, diabetes drug, and LABA
Details on the latest recalls, warnings, and label changes, as well as approvals.
Inhaled insulin and new antibiotic for skin infections approved
Details on the latest recalls, warnings, and label changes, as well as approvals.
Warning issued on epidural steroid injections, new antiplatelet drug approved
Recalls, warnings, and label changes
Doripenem not for pneumonia; migraine prevention device approved
Details on the latest recalls, warnings, and label changes, as well as a device approval.
Cardiac risks of testosterone, saxagliptin under investigation
Details on the latest recalls, warnings, and label changes, as well as drug and device approvals.
New drugs for type 2 diabetes and COPD
Details on the latest recalls, warnings, and label changes, as well as drug and device approvals.
Approvals of drugs to treat seizures, chronic hepatitis C virus infection, depression
Details on the latest drug and device approvals.
Recommended: Move hydrocodone combo products to schedule II
Details on recalls, warnings and label changes.
New labeling on long-acting opioids and fluoroquinolones
Details on recalls, warnings and approvals.
Warnings on hydroxyethyl starch, acetaminophen, ketoconazole
Details on recalls, warnings and approvals.
HbA1c test approved for diagnosing diabetes, more compounded products recalled
Details on recalls, warnings and approvals.
More compounded products recalled, new diabetes drug approved
Details on recalls, warnings, label changes and approvals.
New indication for apixaban, approvals of gastroenteritis test, diabetes drugs
Details on recalls, warnings, label changes and approvals.
Warnings about dabigatran with mechanical valves and telaprevir combo
Details on recalls, warnings, label changes and approvals.
Heparin labeling changed to clarify drug strength
Details on recalls, warnings and label changes.
Expanded approval on rivaroxaban, reassurance on dabigatran
Details on recalls, warnings and approvals.
Meningitis outbreak, burns from joint pain creams
Details on recalls, warnings, label changes and approvals.
Generic pioglitazone, new HIV combination pill approved
Details on recalls, warnings, label changes and approvals.
MS drug associated with seizures, cardiac tests recalled
Details on recalls, warnings, label changes and approvals.
Label changes for ondansetron and cefepime
Details on recalls, warnings, and approvals.
Warnings on overfilled cartridges, counterfeit Adderall
Details on recalls, warnings, and approvals.
Generic irbesartan, escitalopram approved
Details on approvals, recalls, warnings and more.
New warnings for statins, new drug approval for Cushing's syndrome
Details on warnings, approvals and more.
Handheld hematoma scanner, new indication for pneumonia vaccine approved
Details on new approvals and more.
New anticoagulants getting expanded approval, but also review
Details on anticoagulant regulation and more.
Warnings on citalopram, ondansetron; polypill approved
Details on new warnings for higher doses of citalopram hydrobromide, and more.
Rivaroxaban approved, warning issued on pioglitazone
Details on approval of rivaroxaban, a warning about pioglitazone and bladder cancer, and more.
New C. diff drug and MRSA test
Details on approval of a new drug for Clostridium difficile, a new test for methicillin-resistant Staphylococcus aureus, and more.
New gadolinium contrast agent approved
Details on approval of a new gadolinium contrast agent, a recall of certain infusion agents, and more.
Sterile pads and central line trays recalled, mobile radiology app approved
Details on a recall of sterile and non-sterile alcohol prep pads, alcohol swabs, and alcohol swabsticks, and more.
Warnings on morphine overdoses, injections containing particulates
Details on a warning and label changes related to accidental overdoses of morphine sulfate, and more.
New injectable antibiotic approved, infusers recalled
Details on the approval of ceftaroline fosamil, and more.
New anticoagulant and oral MS drug approved
Details on the approval of dabigatran etexilate, and more.
Warning about contrast agents, review underway on Stalevo
Drug recalls, warnings, approvals.
Emergency contraception tablets, influenza vaccines approved
Drug recalls, warnings, approvals.
MRSA test and warfarin recalled, new tests for HIV and hepatitis C
Drug recalls, warnings, approvals.
Major recall of Tylenol and other McNeil products; concerns about BPA in infants, kids
Drug recalls, warnings, approvals
New drug approved for Alzheimer's, warnings issued on CT scans, local anesthetics
Warnings, recalls, approvals
Tracheal tubes, catheters, defibrillators recalled; lymphoma drug approved
Tracheal tubes, catheters, defibrillators recalled; lymphoma drug approved
Safety data reviewed; one-dose emergency contraception pill approved
Review of safety data, recalls, label changes.
Propofol, ventilators, infusion sets recalled
Propofol, ventilators, infusion sets recalled
Digoxin, Biosite Triage Cardiac Panel, insulin pumps recalled
Drug recalls, warnings, approvals.
Recalls for arrhythmia drug, infusion pumps, defibrillators
Drug recalls, warnings, approvals.
Topical anesthetic reminder, fibromyalgia drug approved
Recalls, advisories, and approvals.
Recalls for heart pumps, intrathecal catheters, dextroamphetamine sulfate
Recalls for heart pumps, intrathecal catheters, dextroamphetamine sulfate
Monitor patients with hepatic impairment who take erlotinib
Monitor patients with hepatic impairment who take erlotinib