NDLI: Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Please wait, while we are loading the content...

Safety and Efficacy of Flumazenil for Reversal of Iatrogenic Benzodiazepine-Associated Delirium Toxicity During Treatment of Alcohol Withdrawal, a Retrospective Review at One Center

LIPAEMIC Report: Results of Clinical Use of Intravenous Lipid Emulsion in Drug Toxicity Reported to an Online Lipid Registry

Comparison of Current Recommended Regimens of Atropinization in Organophosphate Poisoning

Nutmeg Poisonings: A Retrospective Review of 10 Years Experience from the Illinois Poison Center, 2001–2011

Clinical Effects of Exposure to DPP-4 Inhibitors as Reported to the National Poison Data System

Warfarin Overdose: A 25-Year Experience

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Mycetism: A Review of the Recent Literature

Vitamin D Toxicity in an Infant: Case Files of the University of California, San Francisco Medical Toxicology Fellowship

Tempest in a Tea Pot: How did the Public Conversation on Genetically Modified Crops Drift so far from the Facts?

Fatal Intravenous Injection of Electronic Nicotine Delivery System Refilling Solution

Use of a Physostigmine Continuous Infusion for the Treatment of Severe and Recurrent Antimuscarinic Toxicity in a Mixed Drug Overdose

Prolonged Use of Intravenous Lipid Emulsion in a Severe Tricyclic Antidepressant Overdose

Deliberate Fingolimod Overdose Presenting with Delayed Hypotension and Bradycardia Responsive to Atropine

Pediatric Chloral Hydrate Poisonings and Death Following Outpatient Procedural Sedation

Clinical Experience of Life-Threatening Dabigatran-Related Bleeding at a Large, Tertiary Care, Academic Medical Center: a Case Series

A Case of Neurotoxicity Following Envenomation by the Sidewinder Rattlesnake, Crotalus cerastes

Analytical Considerations in the Clinical Laboratory Assessment of Metals

Articles You Might Have Missed ( Journal of Medical Toxicology , Volume 10 , Issue 2 )

ACMT Chelation Position Adopted by Oregon Medical Board

Comment on Complications Following Antidotal Use of Intravenous Lipid Emulsion Therapy (Levine et al., J Med Toxicol 2013)

Other Complications Following Lipid Emulsion Therapy : Re: Levine M, Skolnik AB, Ruha AM, et al. (2013) Complications following antidotal use of intravenous lipid emulsion therapy. J Med Toxicol Dec 13. [Epub ahead of print]

The Poison Pen: How Confident Are We About Iocane?

Journal of Medical Toxicology : Volume 10, Issue 1, March 2014

Journal of Medical Toxicology : Volume 9

Journal of Medical Toxicology : Volume 8

Journal of Medical Toxicology : Volume 7

Journal of Medical Toxicology : Volume 6

Journal of Medical Toxicology : Volume 5

Journal of Medical Toxicology : Volume 4

Journal of Medical Toxicology : Volume 3

Journal of Medical Toxicology : Volume 2

Journal of Medical Toxicology : Volume 1

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Content Provider	Springer Nature Link
Author	Nelson, Lewis S. Loh, Meredith Perrone, Jeanmarie
Copyright Year	2014
Abstract	The decision to approve a drug for clinical use is based on an understanding of its benefits versus the risks. Although efficacy is generally understood at the time of submission to the FDA for approval, the risks are more difficult to assess. Both PubMed (from 2000 to 2012) and the FDA website ( www.fda.gov ) were searched using the search terms “risk evaluation and mitigation strategy” (REMS). Articles for review were selected by relevance to topic, and their references were searched as well for additional relevant resources. Since the search results were not expected to contain research studies, formal quality assessment and inclusion and exclusion criteria were not utilized resulting in a narrative review. Few directly relevant research studies exist, although supporting documents such as government reports were available. For effective drugs with unclear or concerning safety records, the FDA has the option of requiring a risk evaluation and mitigation strategy, which allows a systematic approach to track and assure safe medication use. Over 100 different medications are currently covered by REMS, and each REMS is developed individually based on the needs of the specific drug or class. Although likely associated with improvements in medication safety, the potential benefit, limitations, and consequences of REMS are not yet fully understood.
Starting Page	165
Ending Page	172
Page Count	8
File Format	PDF
ISSN	15569039
Journal	Journal of Medical Toxicology
Volume Number	10
Issue Number	2
e-ISSN	19376995
Language	English
Publisher	Springer US
Publisher Date	2014-01-11
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Opioid REMS Safety FDA Risk Pharmacology/Toxicology Biomedicine general
Content Type	Text
Resource Type	Article
Subject	Health, Toxicology and Mutagenesis Toxicology

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Don't sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S.

The changing landscape of opioid prescribing: long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Tramadol is an opioid

Transdermal fentanyl: Pharmacology and toxicology

Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians

ACMT Position Statement: Safety Issues Regarding Prescription Fentanyl Products

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Similar Documents

Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies.

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies

Don't sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S.

The changing landscape of opioid prescribing: long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Tramadol is an opioid

Transdermal fentanyl: Pharmacology and toxicology

Recognition and Knowledge of Medications with Black Box Warnings Among Pediatricians and Emergency Physicians

ACMT Position Statement: Safety Issues Regarding Prescription Fentanyl Products

Assuring Safety of Inherently Unsafe Medications: the FDA Risk Evaluation and Mitigation Strategies