FDA Updates


First drug approved for tardive dyskinesia

This column reviews details on recent recalls, warnings, and approvals.

Warning on IBS drug for patients without gallbladders

This column reviews details on recent recalls, warnings, and approvals.

Warning on rare but serious allergic reactions to antiseptic

This column reviews details on recent recalls, warnings, and approvals.

Warning about cybersecurity; constipation drug approved

This column reviews details on recent recalls, warnings, and approvals.

Label change for pioglitazone-containing medications

This column reviews a label change for medicine that contain pioglitazone and a new indication for empagliflozin.

Warning on steroids; approval for soft-tissue sarcoma drug

This column reviews a warning on testosterone and other anabolic androgenic steroids and approval of a new drug to treat certain adults with soft-tissue sarcoma.

New warnings for opioids; approval for arthritis drug

This column reviews a warning on opioid pain drugs and cough medicines combined with benzodiazepines and approval of a new drug to treat multiple inflammatory diseases.

Updated warnings on fluoroquinolones, new diabetes drug

This column reviews a warning on fluoroquinolones with a risk of disabling and potentially permanent side effects, as well as approval of an injection to improve glycemic control in adults with type 2 diabetes.

Recalls for oral docusate sodium, INR monitoring system

This column reviews a recall of an oral liquid docusate sodium solution because of contamination and of an international normalized ratio monitoring system because it may provide significantly lower results than another method.

Warning on an antipsychotic; generic rosuvastatin approval

This update covers a warning that aripiprazole may be associated with compulsive or uncontrollable urges, as well as approval of the first generic version of rosuvastatin tablets.

Warning on an antipsychotic; generic rosuvastatin approval

This update covers new warnings on the entire class of opioids and approval of the first leadless pacemaker approved to treat heart rhythm disorders.

Approval for cancer drug; proposed ban for gloves

This update covers approval of Crizotinib (Xalkori) to treat people with metastatic non-small-cell lung cancer whose tumors have an ROS-1 gene alteration.

Recall of glucose test strips; approval for hepatitis C drug

This update covers a class I recall of blood glucose test strips which might cause clinicians to overlook hypoglycemia.

Warning about different doses for 2 forms of posaconazole

This update covers a warning that differences in dosing regimens between the 2 oral formulations of posaconazole (Noxafil) have resulted in dosing errors.

Warning on diabetes drugs, approval of adjuvant flu vaccine

This update covers a warning on sodium-glucose cotransporter-2 inhibitors and approval of a trivalent vaccine for the prevention of seasonal influenza in people age 65 years and older.

Warning on HCV treatments; more cancer drugs approved

This update also covers a warning that combination drugs can cause serious liver injury and approval of new drugs for metastatic non-small-cell lung cancer that has progressed after other treatments.

New warnings added on multiple diabetes drugs

This update also covers a risk evaluation and mitigation strategy for liraglutide and approval of a new PCSK9 inhibitor.

Warning on medication confusion, recalls due to sterility

This update covers possible confusion between an antidepressant and an anti-clotting drug, as well as 2 sterility warnings.

Warning on NSAIDs; new schizophrenia drug approved

This update covers a strengthened warning on NSAIDs and a new drug to treat schizophrenia.

FDA approves heart failure drug, looks into antiseptic safety

This update covers a warning that sodium-glucose cotransporter-2 inhibitors can cause ketoacidosis, and approval of a drug that can reduce hospitalizations from worsening chronic heart failure.

Warning on using hep C drugs with amiodarone

This update covers combining amiodarone, sofosbuvir, and another direct-acting antiviral for hepatitis C, as well as the approval of a non-invasive test to aid in the diagnosis of gastroparesis.

Warnings on testosterone, new antibiotic approved

This update covers a label change on testosterone products clarifying that they are approved only for men who have low testosterone levels, as well as the approval of ceftazidime-avibactam (Avycaz) to treat complicated intra-abdominal infections.

Approvals for an oral anticoagulant, generic esomeprazole

This update covers the approval of an oral medication to reduce the risk of stroke and embolism in atrial fibrillation and the first generic version of esomeprazole.

New heart disease test, drugs for flu, weight management

This update covers a new test to predict risk of future coronary heart disease events, the first neuraminidase inhibitor for influenza, and a new GLP-1 agonist for obese people.

Warnings on long-term dual antiplatelet therapy, more

This update covers the recall of rapid gram-negative combo panels, approval of an extended-release opioid analgesic, and a new rule about labeling prescription drugs related to pregnancy and lactation.

New diabetes drug, LABA for COPD, skin antibiotic approved

This update covers approval of a sodium-glucose co-transporter 2 inhibitor for diabetes, a once-daily long-acting beta-adrenergic agonist (LABA) for chronic obstructive pulmonary disease (COPD), and a new intravenous drug for bacterial skin and skin-structure infections.

New warning for testosterone, approval for inhaled insulin

This update covers a revised warning on testosterone products about the risk of venous thromboembolism, and approval of a fast-acting inhaled insulin to treat diabetes in adults.

New drugs for diabetes, secondary prevention of CV events

This update covers approval of a new drug to treat type 2 diabetes mellitus, along with diet and exercise, and of a drug to reduce risk of heart attack, stroke, cardiovascular death, and need for revascularization in patients with a previous heart attack or peripheral artery disease.

New grass allergy treatment, opioid overdose solution

This update covers approval of an allergen extract to treat allergic rhinitis induced by grass pollen and of a handheld injector of naloxone for emergency treatment of known or suspected opioid overdose.

Doripenem not for pneumonia; migraine device approved

This update covers a labeling change for doripenem (Doribax) and a warning about risk of death for ventilator patients with pneumonia, among other regulatory actions.

Cardiac risks of testosterone, saxagliptin under investigation

This regulatory update covers an FDA review of the risk of stroke, heart attack and death in men taking testosterone products, as well as a possible increase in heart failure associated with saxagliptin.

New drugs approved for type 2 diabetes and COPD

This regulatory update covers dapaglifozin (Farxiga) a sodium-glucose co-transporter 2 inhibitor, to treat diabetes, and umeclidinium and vilanterol inhalation (Anoro Ellipta) for maintenance of chronic obstructive pulmonary disease.

Warnings about topical antiseptics, nuclear stress test agents

This regulatory update covers label and packaging changes to over-the-counter topical antiseptic products due to infection risk and approval of the first generic versions of rabeprazole sodium for gastroesophageal reflux disease.

Recommended: Move hydrocodone combo products to schedule II

This regulatory update covers a proposed reclassification of hydrocodone combination products from schedule III to schedule II, and approval of an extended-release version of hydrocodone bitartrate for pain management.

New labeling on long-acting opioids, fluoroquinolones

This regulatory update covers a labeling change for all long-acting opioid analgesics, and another on fluoroquinolone drugs to better describe the serious side effect of peripheral neuropathy.

New warnings on acetaminophen, ketoconazole

This regulatory update covers a rare but serious skin reaction for acetaminophen, as well as new limits on ketoconazole due to risks of liver injury.

New hot flash treatment approved, olmesartan label changed

This regulatory update covers approval of the first nonhormonal treatment for hot flashes associated with menopause, a label change for olmesartan causing intestinal problems, and more.

New COPD treatment, warnings on insomnia and migraine drugs

This regulatory update covers approval of a combined long-term maintenance treatment for chronic obstructive pulmonary disease, warnings against driving after taking insomnia drugs and on use of migraine drugs in pregnant women, and more.

More compounded products recalled, diabetes drug approved

This regulatory update covers a recall of a compounding pharmacy's products due to mold and approval of a sodium-glucose co-transporter for diabetes.

Azithromycin gets warning, incretin mimetics investigated

This regulatory update covers a new warning on azithromycin about abnormal changes in the electrical activity of the heart, and a possible increased risk of pancreatitis and precancerous findings from incretin mimetic drugs.

Zolpidem dose for women lowered, diabetes drug approved

This regulatory update covers warnings to lower zolpidem doses in women and approvals for a new drug to improve blood glucose control in adults with type 2 diabetes.

Warning about using sodium oxybate

This regulatory update covers warnings against mixing sodium oxybate with alcohol and against using dabigatran in patients with mechanical heart valves.

Heparin labeling changed, non-egg flu vaccine approved

This regulatory update covers changed labeling for heparin and approval of a flu vaccine produced using cultured animal cells.

Expanded approval on rivaroxaban, reassurance on dabigatran

This regulatory update covers an expanded indication for rivaroxaban and an announcement that bleeding rates do not appear to be higher with dabigatran than with warfarin.

Generic pioglitazone, new HIV combination pill approved

This regulatory update covers approvals of the first generic form of pioglitazone and a combination form of emtricitabine, tonofavir and two new drugs for patients new to HIV treatment.

HIV prophylaxis and new weight loss drug approved

This regulatory update covers label changes for dalfampridine and approvals for the first generic versions of montelukast sodium for asthma.

Weight-loss drug and at-home HIV test approved

This regulatory update covers approval of lorcaserin HCl for chronic weight management, as well as a new at-home mouth swab test for HIV 1 and 2.

Cautions about mixing HIV, HCV drugs

This regulatory update covers a warning about giving boceprevir with some ritonavir-boosted HIV protease inhibitors, as well as approval of a new erectile dysfunction drug.

Generic irbesartan, escitalopram, ibandronate approved

This regulatory update includes a revision to the label of drospirenone-containing contraceptives and approval of the first generic versions of Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) tablets for the treatment of high blood pressure.

Warning about mixing protease inhibitors with statins

This regulatory update includes a warning on combining protease inhibitors and statins, approval of an orphan drug, and steps the FDA is taking to increase the supply of cancer drugs.

Warning on PPIs and C. diff, contraceptive pill mixup

Recalls, warnings, approvals and other regulatory news.

New pneumonia vaccine option for patients over 50

Recalls, warnings, approvals and other regulatory news.

Generic atorvastatin, middle-of-the-night zolpidem approved

Recalls, warnings, approvals and other regulatory news.

Polypill gets approval, fenofibric acid gets label change

Recalls, warnings, approvals and other regulatory news.

Emergency contraception drug, flu vaccines approved

Recalls, warnings, approvals and other regulatory news.

Leflunomide gets boxed warning, ARBs under review

Recalls, warnings, approvals and other regulatory news.

Recalls expanded on defibrillators, infusion pumps

Recalls, warnings, approvals and other regulatory news.

FDA approves generic hypertension drugs, looks at Stalevo

Recalls, warnings, approvals and other regulatory news.

Warnings on clopidogrel, high-dose simvastatin, ear candles

Warnings, recalls and approvals from the Food and Drug Administration.

Risks seen with anemia, asthma drugs; insulin syringes recalled

Warnings, recalls and updates from the Food and Drug Administration.

Ketorolac, Liposyn recalled for particulate contamination

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Warnings on power cords, asthma drugs, diabetes supplies

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Recalls: Propofol, ventilators, infusion sets, acetaminophen

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Warnings for varenicline, bupropion; pacemaker recalled

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Digoxin, Biosite Triage Cardiac Panel, insulin pumps recalled

A summary of approvals, recalls, warnings and alerts digested by ACP Internist from the Food and Drug Administration's alerts.

Recalls for arrhythmia drug, infusion pumps, defibrillators

A summary of approvals, recalls, warnings and alerts from the Food and Drug Administration.

Boxed warning for metoclopramide, alert for zonisamide

A summary of approvals, recalls, warnings and alerts.

Peanut butter recall issued, reminder for topical anesthetics

A summary of approvals, recalls, warnings and alerts.

Warnings issued for antiepileptics, bowel prep, efalizumab

A summary of approvals, recalls, warnings and alerts.

Recall of generic drugs, acne cream; depression device OK'd

A summary of approvals, recalls and a record number of deaths and serious injuries reported.

FDA bans dozens of generics from entering U.S. for quality

The latest recalls, warnings, label changes and approvals from the Food and Drug Administration.

Actavis recalls more than 60 generics, six flu vaccines OK'd

The latest recalls, warnings, label changes and approvals from the Food and Drug Administration.

FDA issues alert for CellCept, recalls for Solodyn, Digitek

An overview of agency actions, including an alert for CellCept and recalls for Solodyn and Digitek.

New test detects MRSA within 24 hours

Approvals, alerts, warnings, and recalls.

Rapid blood test to detect MRSA

The latest drug alerts and approvals