Navigation Links
Beyond the Headlines: What the FDA Decisions on Extended-release and Long-Acting Opioids Mean for People With Pain
Date:9/17/2013

CHICAGO, Sept. 17, 2013 /PRNewswire-USNewswire/ -- The physicians of the American Academy of Pain Medicine (AAPM) hailed long-awaited labeling changes and other steps taken by the U.S. Food and Drug Administration (FDA) last week to enhance safety in the prescribing of extended-release and long-acting (ER/LA) opioids. AAPM further supported the Agency's decision to deny portions of a citizen petition seeking dosage and treatment duration limits that would have applied to every patient regardless of individual circumstance. The Academy had previously argued that the proposed limits were arbitrary, lacked scientific substantiation, and could lull prescribers into solely focusing on dose, which could have led to ignoring additional risk factors.

The FDA considered thousands of comments and pieces of scientific literature to reach its recommendations, which were announced last week. Seeking today to provide perspective on what the FDA decisions mean for patient care, AAPM leaders praised the agency's careful, judicious review of the evidence and its move toward advocating individualized therapy.

"These were good moves for people who suffer the most intractable, severe pain and who find alternatives to opioids ineffective," said Lynn R. Webster, MD, president of AAPM. "It is important for us to put the FDA's actions in context and to make sure the clinical implications are understood. Incomplete or inaccurate reporting on what the agency did could influence a doctor's medical decisions, putting patients at risk."

One important development was adding a prominent boxed warning that babies born to mothers on opioids may experience opioid dependency and exhibit withdrawal symptoms.

The FDA further announced new requirements for holders of ER/LA applications to conduct long-term studies to assess risks of misuse, abuse, hyperalgesia (increased pain sensitivity), addiction, and overdo
'/>"/>

SOURCE American Academy of Pain Medicine
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Achieve Beyond Pediatric Therapy Offers Exciting CEU Workshop in Virginia
2. MD&M Minneapolis Conference Returns, October 28-30, With a Cutting-Edge Tailored Program Addressing the Most Critical Challenges for the Medical Devices Industry for 2013 and Beyond
3. Celebrating 25 Years and Counting: Leukemia and Lymphoma Societys "Team In Training" Goes the Distance and Beyond for Blood Cancer Patients
4. Moving Beyond the Pill: Data Science to Impact Medicine More than the Drugs Themselves
5. Generex Points to Potential of Antigen Express Technology Platform beyond Its AE37 Breast Cancer Vaccine
6. Home Access Health Corp. encourages cholesterol testing during American Heart Month, beyond
7. CVS Caremark Provides Strong Growth Outlook for 2013 and Beyond, Announces 38%Dividend Increase and Outlines Strategic Growth Framework
8. Beyond Lucid Technologies Receives Funding From Dalmore Investments
9. EORNA Spearheads Harmonisation of Nursing Education Standards Beyond Europe
10. Multiple International Breast Cancer Guidelines Confirm Use of Agendia Tests for Prognostic, Predictive Information in Cancer Treatment Decisions
11. Health Decisions CEO Michael Rosenberg, MD, MPH, Offers Insights into Adaptive and Risk-Based Monitoring in the Journal of Clinical Research Best Practices
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... -- Cyberonics, Inc. (NASDAQ: CYBX ), a global ... epilepsy, today announced it will participate in the 33 rd ... 2015, in San Francisco . ... will speak at 11:00 AM Pacific Time.  A live audio ... the Investor Relations link on the Cyberonics home page at ...
(Date:12/22/2014)... , Dec. 22, 2014 /PRNewswire/ -- RXi Pharmaceuticals ... company focused on discovering, developing and commercializing innovative ... technologies, today issued the following open letter to ... , Dr. Med. Sc. Dear RXi ... a number of inaccurate statements posted on certain ...
(Date:12/22/2014)... Calif. , Dec, 22, 2014  Eiger ... Phase 2a study of lonafarnib in patients with ... was conducted at the National Institutes of Health ... .  The double-blinded, randomized, placebo-controlled, dose ascending ... twice daily and 200 mg twice daily for ...
Breaking Medicine Technology:RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 2Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting 3
... LOUIS, May 4, 2011 Stereotaxis, (Nasdaq: ... a broad spectrum of complex arrhythmias will again be ... Annual Heart Rhythm Scientific Sessions in San Francisco, California. ... data and discussions of the value of magnetic navigation ...
... At the Board of Directors meeting held today, the ... The dividend is payable on June 15, 2011 to shareholders ... About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science ... the Quality of Life. Its chemical and biochemical products and ...
Cached Medicine Technology:Stereotaxis' Continued Leadership in Scientific Outcome Data Prominently Displayed with Multiple Key Presentations at HRS 2011 2Stereotaxis' Continued Leadership in Scientific Outcome Data Prominently Displayed with Multiple Key Presentations at HRS 2011 3Stereotaxis' Continued Leadership in Scientific Outcome Data Prominently Displayed with Multiple Key Presentations at HRS 2011 4Stereotaxis' Continued Leadership in Scientific Outcome Data Prominently Displayed with Multiple Key Presentations at HRS 2011 5
(Date:12/22/2014)... Naples, Florida (PRWEB) December 22, 2014 ... this holiday season, the gift of health and vitality. ... is offering its three top-selling anti-aging formulas in special ... with free rush delivery. , Each bottle contains ... digestion, areas that don't work as well as we ...
(Date:12/22/2014)... 2014 Xarelto Lawsuit News : ... judges has granted a request to centralize pending and ... Court, Eastern District of Louisiana. The U.S. Judicial Panel ... 12 to transfer over 50 Xarelto cases–21 lawsuits and ... Louisiana court for consolidation under U.S. District Judge Eldon ...
(Date:12/22/2014)... December 22, 2014 Christmas is days away, ... a fast and easy solution that will please: the ... be purchased from from $25 up to $350," says Kathy ... customer satisfaction and a wide array of skin care products ... and no expiration dates. , Gift delivery past shipping ...
(Date:12/22/2014)... The NLN’s 2015 Leadership ... this month. Faculty have been selected through competitive ... fast-tracked for administrative leadership roles within their academic ... Simulation Educators, featuring a curriculum uniquely devised for ... , Twenty nurse educators were chosen for ...
(Date:12/21/2014)... Recently, BambooFlooringChina.com, a famous bamboo lumber supplier, has ... and launched a bamboo flooring promotion with great discounts, ... 30, 2015. , According to the CEO of the ... available today; it has a highly distinctive grain with ... woven bamboo is made by a unique manufacturing process ...
Breaking Medicine News(10 mins):Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 2Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 3Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 4Health News:NLN Leadership Institute Announces 2015 Cohorts 2Health News:NLN Leadership Institute Announces 2015 Cohorts 3Health News:BambooFlooringChina.com Announced Its Durable Strand Woven Bamboo Flooring Collection 2
... governing the private educational institutions in the state in ... cabinet decided to adopt the new rules for the ... said here. ,The school managements will now ... prescribed and timely salaries to teaching and non-teaching staff ...
... drink and the sparkle of many a party. That apart, wine ... a health drink, known to sustain cardiovascular// health and keep age ... health, it is cheers to a copious flow of health benefits. ... wine is considered sacrosanct, alluding to the blood of Christ, which ...
... Chapel Hill suggested that low LDL values can increase ... for low density lipoprotein; the low values of LDL ... been made between LDL and cardiovascular diseases, smoking and ... a lower occurrence of heart attack and stroke than ...
... “trans fat” leaves a bad taste in the mouths ... for health, but// scientists at the University of Arkansas ... by juggling the molecular structure of soy oil. ... student Vishal Jain produced soy oil rich in conjugated ...
... are the best ways to prevent the most common types ... paediatricians.// ,Kidney stones are rarely a serious condition, ... infections. Signs and symptoms of kidney stones include intense pain ... painful urination, blood in the urine and/or cloudy urine, urinary ...
... progression of Alzheimer's disease (AD) according to a study ... is one// in a group of related steroid hormones ... published in the December 20 issue of The Journal ... testosterone loss and AD, which affects 4.5 million Americans. ...
Cached Medicine News:Health News:Celebrating Christmas With Wine – The Elixir of the God 2Health News:Celebrating Christmas With Wine – The Elixir of the God 3Health News:Low LDL Levels Lead to Parkinson's Disease 2Health News:Healthy Potato Chips: A Trans Fat Oil With Health Benefits 2Health News:Drinking Plenty of Water may Prevent Kidney Stones 2Health News:Increase Testosterone Levels To Slow Down Alzheimer’ 2
... The GENIE is the proven electrophoretic transfer ... in field uniformity. Its design allows for a ... coupled with a low voltage power source such ... in volts/cm. The result is exceptionally rapid and ...
... Trans-Blot cell, a component of Bio-Rad's modular ... provides rapid, high-quality blotting of mini gels. ... x 10 cm gels in just 1 ... cooling unit, which absorbs heat generated during ...
... Includes PowerPac 200 power ... Range of Parameters. Quantitative Transfers. ... or Overnight Transfers. Faster, ... High Field-Intensity Transfers with ...
... gel holder cassettes, cell with ... pads, blot absorbent paper (15 ... transfer cell, used with the ... efficient, high-intensity electrophoretic transfers. The ...
Medicine Products: