FDA News

FDA Adds Safety Warnings to Fluoroquinolones

FDA Adds Safety Warnings to Fluoroquinolones

Fluoroquinolones such as Cipro, Levaquin should be reserved for life-threatening infections.

FDA Approves First Absorbable Stent for CAD

FDA Approves First Absorbable Stent for CAD

The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

Calcifediol formulation is indicated for CKD stage 3 or 4 patients with secondary hyperparathyroidism associated with vitamin D insufficiency.

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

Food Industry Needs to Reduce Sodium, FDA Says

Food Industry Needs to Reduce Sodium, FDA Says

The FDA has developed 2- and 10-year goals to reduce sodium content in both processed and prepared foods.

Nutrition Facts Label Revised

Nutrition Facts Label Revised

Added sugars, relevant portion sizes among the highlights of revision.

Drug Cleared for Refractory Advanced Bladder Cancer

Drug Cleared for Refractory Advanced Bladder Cancer

Atezolizumab received accelerated FDA approval for patients whose disease has progressed despite platinum-based chemotherapy.

Serious Side Effects With Fluoroquinolones, FDA Warns

Serious Side Effects With Fluoroquinolones, FDA Warns

Agency is recommending that health care providers not prescribe them for certain patients.

FDA's 'Breakthrough' Drug Designation Misunderstood

FDA's 'Breakthrough' Drug Designation Misunderstood

Many believe meds supported by stronger evidence than the law requires to achieve designation.

Metformin Use Expanded to Some Patients With Reduced Kidney Function

Metformin Use Expanded to Some Patients With Reduced Kidney Function

The diabetes drug was contraindicated due to the risk of lactic acidosis.

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

Drugs containing saxagliptin or alogliptin may be linked to heart failure risk.

FDA Adds Boxed Warning to Opioid Pain Medications

FDA Adds Boxed Warning to Opioid Pain Medications

New labeling rules require immediate-release opioids to carry warnings for the serious risk for misuse.

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

Agency aims to improve treatment of pelvic organ prolapse.

FDA Allows Blood Donations by Men Who Have Sex With Men

FDA Allows Blood Donations by Men Who Have Sex With Men

National blood surveillance system will help agency ensure safety of the blood supply.

Uptravi Approved for Pulmonary Arterial Hypertension

Uptravi Approved for Pulmonary Arterial Hypertension

Drug found to limit worsening of the disease and reduce the need for hospitalization.