FDA Update


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.

Pacemakers, stents recalled

Recalls, warnings, alerts, and approvals.

Ranitidine pulled from market due to contamination

Details on recalls, withdrawals, and approvals.

Infusion pump recalls, fecal transplant alert

Details on recalls, warnings, and approvals.

Warning about clozapine and constipation

Details on recalls, warnings, and approvals.

First Ebola virus vaccine approved

Details on the latest alerts, recalls, 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.

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.

New drug approval for HAP and VAP

Details on the latest alerts, recalls, and approvals.

Ventilator recall, generic naloxone approval

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 antiviral for flu approved

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.

New, stronger MRI approved

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.

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.

Ventilators, patch, and injections recalled

Details on the latest recalls, warnings, and approvals.

New antifungal for aspergillosis and mucormycosis approved

Details on the latest recalls, warnings, and approvals.

New antiviral, antibiotic approved

Details on the latest recalls, warnings, and approvals.

New tests for acute kidney injury and yeast bloodstream infections

Details on the latest recalls, label changes, 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.

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.

New warnings on tigecycline, ofatumumab

Details on recalls, warnings and approvals.

Warnings about liver injury, blue skin

Details on recalls, warnings and label changes.

More compounded products recalled, new diabetes drug approved

Details on recalls, warnings, label changes 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.

Cautions about mixing HIV, HCV drugs

Details on recalls, warnings, and approvals.

Generic irbesartan, escitalopram approved

Details on approvals, recalls, warnings and more.

Warnings on citalopram, ondansetron; polypill approved

Details on new warnings for higher doses of citalopram hydrobromide, and more.

New blood thinner, HIV combo drug approved

Details on approval of ticagrelor 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.

Clopidogrel gets new warning

Drug warnings, recalls, approvals

Tracheal tubes, catheters, defibrillators recalled; lymphoma drug approved

Tracheal tubes, catheters, defibrillators recalled; lymphoma drug approved

Propofol, ventilators, infusion sets recalled

Propofol, ventilators, infusion sets recalled

FDA Update

New opioid therapy guidelines, and more

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

Warnings on antipsychotics, becaplermin

Warnings on antipsychotics, becaplermin

New test detects MRSA within 24 hours

New test detects MRSA within 24 hours