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Babies May Be More Sensitive to Pain Than Adults

Posted 4 days ago by

TUESDAY, April 21, 2015 – Babies feel pain in much the same way as adults, says a new study that challenges some experts' beliefs that babies don't feel pain. Some people have argued that babies' brains aren't developed enough for them to really "feel" pain, said study lead author Dr. Rebeccah Slater, of the department of pediatrics at Oxford University in England. "Our study provides the first really strong evidence that this is not the case," Slater said. "Our study suggests that not only do babies experience pain, but they may be more sensitive to it than adults," she said in a university news release. The study included 10 healthy infants, ages 1 to 6 days, and 10 healthy adults, ages 23 to 36. All underwent MRI scans of their brains while they were poked on the bottom of their feet. The results showed that 18 of the 20 brain regions that were active in adults in response to pain ... Read more

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Health Tip: Exercising With Knee Problems

Posted 10 days ago by

-- Exercise may be just what the doctor ordered if you have knee pain. The American Academy of Orthopaedic Surgeons suggests: Start out exercising slowly, and over time build up the duration and intensity of your workout. While some discomfort is OK, pain is not. You should stop if you feel pain in your knee. A little stiffness or soreness is OK, but significant pain the day after exercising probably means you've overdone it. Talk to your doctor or physical therapist if you have questions about exercising with knee pain. Read more

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FDA Issues Final Guidance on the Evaluation and Labeling of Abuse-Deterrent Opioids

Posted 1 Apr 2015 by

April 1, 2015 – The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse. The document “Gu ... Read more

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One-Quarter of Narcotic Painkillers Misused, Study Shows

Posted 1 Apr 2015 by

WEDNESDAY, April 1, 2015 – Almost a quarter of powerful narcotic painkillers that are prescribed for chronic pain are misused, and the rate of addiction among patients hovers near 10 percent, a new review shows. The findings raise questions about the benefits of widespread use of these painkillers to treat chronic pain, the researchers said. "On average, misuse was documented in approximately one out of four or five patients, and addiction [was found] in approximately one out of 10 or 11 patients," who were prescribed the drugs as part of their treatment for chronic pain, wrote Kevin Vowles, from the University of New Mexico, and colleagues. In the new review, researchers analyzed 38 published studies, 35 of which were conducted in the United States. The average rates of misuse were 21 percent to 29 percent, while the average rates of addiction were 8 percent to 12 percent, according ... Read more

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Young Pitchers Often Pressured to Play Despite Pain, Study Says

Posted 24 Mar 2015 by

TUESDAY, March 24, 2015 – Young baseball players feel pressure from parents or coaches to continue playing despite arm pain, and many parents are unaware of guidelines to reduce injury risk, a pair of recent studies found. "Kids are playing harder and longer in more leagues than ever before," said Dr. Paul Saluan, director of pediatric and adolescent sports medicine at the Cleveland Clinic. "Kids also are not getting enough rest in between episodes of pitching, which may lead to insufficient time to heal smaller stress injuries. Over time, these smaller injuries add up." The studies are scheduled for presentation March 24 at the American Academy of Orthopaedic Surgeons' annual meeting in Las Vegas. Data and conclusions presented at meetings are usually considered preliminary until published in a peer-reviewed medical journal. The co-author of one of the studies explained how players ... Read more

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British Scientists Spot Brain's Pain Center

Posted 9 Mar 2015 by

MONDAY, March 9, 2015 – British researchers say they've identified the area of the brain linked to pain intensity. The University of Oxford team used a new imaging technique to observe how different levels of pain affected the brains of 17 volunteers. Activity in only one area of the brain – the dorsal posterior insula – matched the participants' self-reported pain ratings. This method could be used to help assess pain levels in people who have difficulty providing doctors with that information, such as those in a coma, small children or dementia patients, said the authors of the study published March 9 in the journal Nature Neuroscience. "We have identified the brain area likely to be responsible for the core, 'it hurts', experience of pain," researcher Irene Tracey said in a university news release. "Pain is a complex, multidimensional experience, which causes activity in many ... Read more

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Narcotic Painkiller Use Tied to Higher Risk for Depression

Posted 20 Feb 2015 by

FRIDAY, Feb. 20, 2015 – High doses of powerful narcotic painkillers appear to be linked to a higher risk of depression in patients, new research finds. The study focuses on a class of prescription narcotic painkillers called opioids, which include drugs such as Oxycontin and Vicodin. While most people use the medicines to ease pain, widespread abuse of narcotic painkillers is also a growing concern. The new study involved 355 patients in Texas who reported low back pain at an initial medical visit and still had the pain one and two years later. Although the study couldn't prove cause-and-effect, people who used higher doses of narcotic painkillers to manage their pain were more likely to have an increase in depression, the researchers found. Learning more about the link between these painkillers and depression, along with what dosage might put patients at higher risk, "may inform ... Read more

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Many Americans Face Pain, Depression in Their Final Year

Posted 2 Feb 2015 by

MONDAY, Feb. 2, 2015 – For a growing number of Americans, the final year of life is marked by pain, depression and other distressing symptoms, a new study finds. Experts said the study, published Feb. 2 in Annals of Internal Medicine, highlights disturbing shortcomings in the U.S. health care system. Researchers found that between 1998 and 2010, the number of Americans who suffered pain in their last year of life rose from 54 percent to 61 percent. Meanwhile, the prevalence of depression rose from 45 percent to 57 percent, while other symptoms – such as breathlessness, confusion, severe fatigue and incontinence – either increased or did not improve. "These findings are troubling," said senior researcher Dr. Karl Lorenz, of the Pardee RAND Graduate School and the University of California, Los Angeles. The increase in end-of-life symptoms, Lorenz said, has occurred despite national ... Read more

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Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER

Posted 30 Jan 2015 by

SAN DIEGO, Jan. 30, 2015 – Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™. BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended. Concurrently, Zogenix has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation. Zogenix intends to submit these data in the second half of 2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, ... Read more

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FDA Medwatch Alert: Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

Posted 20 Jan 2015 by

[Posted 01/09/2015] ISSUE:  FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. ... Read more

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Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject (diclofenac sodium) Injection

Posted 30 Dec 2014 by

LAKE FOREST, Ill., Dec. 30, 2014 /PRNewswire/ – Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration (FDA) for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics. "In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organizations are now recommending a multi-modal approach to pain control in an effort to minimize the use of opioids," said Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, ... Read more

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U.S. Doctors Cutting Back on Painkiller Prescriptions: Study

Posted 8 Dec 2014 by

MONDAY, Dec. 8, 2014 – Nine out of 10 primary care doctors in the United States are concerned about prescription drug abuse in their communities, a new study finds. And, nearly half of the physicians surveyed said they were less likely to prescribe powerful painkillers than they were just a year ago. Researchers surveyed 580 internists, family doctors and general practitioners across the country. They found that 85 percent of doctors believe that narcotic painkillers (opioids such as Oxycontin) are overused in clinical practice. Around half of those surveyed said they were "very concerned" about risks such as addiction, death and traffic crashes associated with narcotic painkiller overuse. Almost two-thirds of the doctors believe that tolerance to the drugs occurs often. Just over half believe that physical dependence is a common problem. And, the doctors said these issues can happen ... Read more

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FDA Approves Hysingla ER - Extended-Release Hydrocodone with Abuse-Deterrent Properties

Posted 25 Nov 2014 by

November 20, 2014 – The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are ex ... Read more

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Abuse-Resistant Prescription Painkiller Approved

Posted 21 Nov 2014 by

THURSDAY, Nov. 20, 2014 – The U.S. Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an abuse-resistant, extended release form of the painkiller hydrocodone (best known as Vicodin). The drug is sanctioned for long-term severe pain that requires daily, around-the-clock treatment. The tablet is difficult to crush, break or dissolve, making it resistant to abuse, the agency said Thursday in a news release. But the medication can still be abused, and an overdose can lead to death, the FDA warned. Hysingla ER shouldn't be used for "as-needed" pain relief, the agency added. The drug's safety and effectiveness were evaluated in clinical studies involving 905 people with chronic lower-back pain. The most common side effects were constipation, nausea, fatigue, upper respiratory tract infection, dizziness and headache. The FDA said it has ordered a post-marketing ... Read more

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Pain, Depression Tied to Delirium Risk After Surgery for Seniors

Posted 11 Nov 2014 by

TUESDAY, Nov. 11, 2014 – Pain and depression before an operation may increase seniors' risk for delirium after surgery, a new study suggests. Rates of delirium after surgery are highest among older patients, occurring in up to 51 percent of those aged 65 and older. Previous research has also shown that depression is a major risk factor for delirium, which is a disoriented state marked by a sharp decrease in attention and mental abilities. This study included 459 patients without dementia, aged 70 and older, who had orthopedic surgery. The patients' pain and depression levels were assessed before surgery. Twenty-three percent of the patients experienced delirium after surgery, the investigators found. Delirium occurred much more often in patients who had depression and pain before surgery, according to the study published recently in The Lancet Psychiatry. Further analyses found that ... Read more

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