FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

Update: 2018-01-05

Description

The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.

Report side effects involving GBCAs to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and a list of FDA approved GBCAs can be found at www.fda.gov/DrugSafety.

Released 12/19/2017

Comments

In Channel

The FAERS Public Dashboard and its Value to the Pharmaceutical Industry

2018-07-3124:45

FDA Warns of Serious Immune Reaction with Seizure/BPD Medicine Lamotrigine (Lamictal)

2018-05-0402:59

FDA D.I.S.C.O.: First Biosimilar Approval for the Treatment of Cancer

2018-01-07--:--

FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

2018-01-0502:59

FDA Review: Adding LABAs to ICS Treatment Does Not Significantly Increase Serious Asthma Outcomes Risk

2018-01-0403:00

Pinpointing the Top Questions about Biosimilars in Rheumatology

2017-11-3033:00

The FDA's Adverse Event Reporting System (FAERS) Public Dashboard

2017-10-2909:22

FDA D.I.S.C.O.: L-Glutamine for Sickle Cell Disease

2017-08-1705:29

FDA D.I.S.C.O.: Osimertinib for Non-Small Cell Lung Cancer

2017-07-28--:--

FDA D.I.S.C.O.: Two Approvals for ALK-Positive Non-Small Cell Lung Cancer

2017-07-25--:--

FDA D.I.S.C.O.: First Tissue/Site Agnostic Cancer Treatment Approval

2017-05-30--:--

FDA D.I.S.C.O.: Avelumab in Merkel Cell Carcinoma

2017-05-22--:--

FDA D.I.S.C.O.: Niraparib in Ovarian Cancer

2017-05-18--:--

FDA D.I.S.C.O.: Rucaparib in Ovarian Cancer

2017-05-1705:00

FDA Confirms Leg and Foot Amputation Risk with Diabetes Medicine Canagliflozin

2017-05-1603:00

Introducing FDA's Drug Information Soundcast in Clinical Oncology (DISCO)

2017-05-1603:30

FDA Restricts Use of Prescription Codeine and Tramadol Pain Medicines in Children

2017-04-2003:00

New Safe Use Requirements for Long-Acting Beta-Agonists (LABAs)

2010-02-2302:00

FDA: Product Confusion with Maalox Total Relief and Maalox Liquid Products

2010-02-1803:00

FDA: Advisory on Body Building Products

2009-06-1702:51

00:00

FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

#box-pro-ellipsis-176132316389963{-webkit-line-clamp:2;}FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents