LatestFDA Alerts

New Rx for Heart Failure Approved

The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.

Blue Bell Expands Ice Cream Recall

FOR IMMEDIATE RELEASE — April 7, 2015 — Brenham, TX Blue Bell Creameries is expanding its recall of products that were produced in the Broken Arrow, Okla., plant to include Banana Pudding Ice Cream pints which tested positive for Listeria monocytogenes, and additional products manufactured on the same line.

FDA Approves Test for Delayed Gastric Emptying

The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.

FDA Approves Rx for Inhalation Anthrax

The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

New Treatment for Diabetic Retinopathy

The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

FDA Approves Blood Pump System

The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures.

Rx for Rare Metabolic Conditions Approved

Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

Trader Joe's Recalls Raw Walnuts

Trader Joe’s Company is recalling Raw Walnuts because these products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

FDA Warns Against Diet Pill

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Botanical Slimming, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.

Herb Viagra May Contain Hidden Ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Herb Viagra, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.