Español [embedded content] Most people have had an X-ray taken at some time during their lives — perhaps checking for a possible broken bone or during a visit to the dentist. X-ray exams provide important information to physicians about how to treat their patients. However, X-rays use ionizing radiation, and these imaging exams must be…
Use Eye Cosmetics Safely
The Food and Drug Administration (FDA) regulates all cosmetics marketed in the United States, including mascara, eye shadows, eye liner, concealers, and eyebrow pencils. Safety experts within the Office of Cosmetics and Colors in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) offer consumers the following advice: Keep everything clean. Dangerous bacteria or fungi…
August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality
December 2, 2021 Update: The FDA launched a new web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The new web page includes: Paclitaxel-coated balloons and stents approved in the United States Current recommendations for health care providers Risks associated with paclitaxel-coated balloons…
UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. On November 30, 2021, NuVasive issued a field safety notice to inform…
Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR
Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated Brand Name: Brand Name(s) Product Description: Product Description Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR Company Announcement WAYNE, Pa.,…
How Sweet It Is: All About Sugar Substitutes
Image Español Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods. They can be used alone to sweeten foods and beverages such as iced tea…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On November 17, 2021, the FDA approved pembrolizumab (brand name…
P&G Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray Products Due to Detection of Benzene
Summary Company Announcement Date: November 23, 2021 FDA Publish Date: November 23, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of benzene Company Name: The Proctor & Gamble Company Brand Name: Brand Name(s) Old Spice Secret Product Description: Product Description Old Spice and Secret Aerosol Sprays Company Announcement The…
Mercury Poisoning Linked to Skin Products
Español Tagalog 日本語 简体中文 한국어 Việt Whatever your complexion, it’s important to use products that will help your skin and not damage it. But as you wade through the beauty aisles, the U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions that contain mercury. How will…
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance
Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Sagent Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Levetiracetam Injection Company Announcement CHICAGO, IL – November 19, 2021 – Sagent Pharmaceuticals, Inc. today announced…