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ERs Dispensing More Narcotic Painkillers: Study

Posted 23 Mar 2014 by Drugs.com

FRIDAY, March 21, 2014 – More and more Americans are being prescribed powerful narcotic drugs when they visit the emergency department for problems such as low back pain or a pounding headache, a new study finds. Between 2001 and 2010, emergency departments in the United States showed a 49 percent increase in prescriptions for narcotic painkillers – also known as opiates. That was despite the fact that there was only a small increase in the percentage of visits for painful conditions. Experts said the trend is concerning because narcotic painkillers – which include drugs like OxyContin, Percocet and Vicodin – can be addictive, or abused by people with existing drug problems. And while the drugs may be necessary for more-severe pain, ER doctors see many patients who can stick with over-the-counter pain relievers. "In many cases, naproxen, Tylenol (acetaminophen) and ibuprofen are the ... Read more

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Pain Can Plague Women After Knee Replacement Surgery

Posted 13 Mar 2014 by Drugs.com

THURSDAY, March 13, 2014 – Women with certain kinds of arthritis are among groups of patients who are most vulnerable to serious pain after undergoing knee replacement surgery, a new study finds. General anesthesia and longer time in a tourniquet also appear to contribute to higher levels of pain, the study authors said. "There is no question that pain after total knee replacement is greater than that after total hip replacement," Dr. Thomas Sculco, surgeon-in-chief at New York City's Hospital for Special Surgery, said in a hospital news release. "Many factors play a role, and our studies found that younger female patients, particularly those with post-traumatic or rheumatoid arthritis, had the highest pain scores." Sculco and his colleagues examined the medical records of 273 patients who underwent total knee replacement procedures from 2007 to 2010. Those who suffered the most pain ... Read more

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FDA Approves Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)

Posted 12 Mar 2014 by Drugs.com

DUBLIN--(BUSINESS WIRE)--Mar. 12, 2014-- Mallinckrodt plc today announced that the U.S. Food and Drug Administration (FDA) has approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated or would otherwise be inadequate. Xartemis XR is the first and only extended-release oral combination of two clinically proven pain medications – oxycodone and acetaminophen. Xartemis XR has both immediate- and extended-release components: formulated to provide onset of pain relief in less than one hour and to allow twice daily dosing. The product’s release profile combines Mallinckrodt’s newly patented technology, including design, formulation, pha ... Read more

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Hormones Might Offer Relief From Chronic Pain, Small Study Suggests

Posted 10 Mar 2014 by Drugs.com

SATURDAY, March 8, 2014 – A combination of two hormones might make a difference in reducing suffering in people with chronic pain, according to a small, preliminary study. Seven of 9 patients reported a 30 percent to 40 percent decrease in pain after taking doses of oxytocin and human chorionic gonadotropin, the researchers found. In addition, the level of opioid (narcotic) painkillers needed by these seven patients also declined by 30 percent to 40 percent. Patients also reported improvement in the intensity of pain flare-ups and longer time between flares, the study authors said. Oxytocin is known as the "love hormone" and has been linked to positive human emotions. Human chorionic gonadotropin plays a role during pregnancy. Levels of both hormones increase during and after childbirth, and they're thought to contribute to lower levels of pain in pregnant women. Study author Dr. ... Read more

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Groups Push FDA to Revoke Approval of Highly Potent Painkiller

Posted 26 Feb 2014 by Drugs.com

WEDNESDAY, Feb. 26, 2014 – Dozens of experts and health care agencies sent a letter this week urging that the U.S. Food and Drug Administration revoke its approval of the supercharged painkiller, Zohydro ER. In the petition sent to the FDA on Wednesday, more than 40 consumer watchdog groups, addiction treatment groups and others noted that the drug was approved despite significant resistance from the FDA's own advisory committee, which voted 11-2 against allowing Zohydro ER to be sold. According to consumer advocate group Public Citizen, which issued its own news release on the issue Wednesday, a single dose of Zohydro ER could kill a child. The petition to the FDA warns that the painkiller is simply too dangerous and there's no need for another high-dose opioid (prescription narcotic) painkiller. "I'm amazed that the FDA would approve a dangerous new [medicine] over the strong ... Read more

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Most Teens With Fibromyalgia Suffer Pain, Fatigue as Adults

Posted 26 Feb 2014 by Drugs.com

WEDNESDAY, Feb. 26, 2014 – Four out of five teens suffering from juvenile fibromyalgia will continue to have pain and other symptoms in adulthood, a new study finds. About half of these children will end up as grown-ups with full-blown adult fibromyalgia, the researchers found. "Half of the former teens we studied met the full criteria for adult fibromyalgia, and another 35 percent of them continued to have symptoms of fatigue, pain and sleep difficulty, but did not meet all the criteria for fibromyalgia syndrome," said study author Susmita Kashikar-Zuck, research director in behavioral medicine and clinical psychology at Cincinnati Children's Hospital Medical Center. The study, published in the March print issue of Pediatrics, stemmed from research into juvenile fibromyalgia, Kashikar-Zuck said. Fibromyalgia is a mysterious disorder that causes muscle pain and fatigue. People with the ... Read more

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Amputee's 'Phantom Limb' Pain Eased by Virtual Arm Technology

Posted 25 Feb 2014 by Drugs.com

TUESDAY, Feb. 25, 2014 – A unique way to possibly treat the intense pain of phantom limb syndrome has been invented – by creating a virtual world for an amputee to enter via computer. Within that world, the patient controlled a "virtual arm" and apparently relieved his pain by tricking his brain into thinking his body was whole again, according to a new report. It's not clear if the virtual treatment will reduce pain in anyone else who suffers from the mysterious phantom limb condition, and no one knows if the effects are permanent. The cost isn't known, either. For now, however, the treatment has made a big difference in the life of the patient, who suffered from phantom limb pain for decades, the researchers said. "Pain stopped being a big part of his life," said study author Max Ortiz-Catalan, a graduate student in the division of biomedical engineering at Sweden's Chalmers ... Read more

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Iroko Pharmaceuticals Receives FDA Approval for Tivorbex

Posted 25 Feb 2014 by Drugs.com

PHILADELPHIA, FEBRUARY 24, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults1. Tivorbex was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market2. FDA approval of Tivorbex was supported by data from two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving Tivorbex compared with patients receiving placebo3. “The FDA approval of Tivorbex is another significant milestone for Iroko as it validates our s ... Read more

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Restless Sleep Linked to Widespread Pain in Older Adults

Posted 13 Feb 2014 by Drugs.com

THURSDAY, Feb. 13, 2014 – Waking up and not feeling rested isn't just annoying. Researchers say that "non-restorative sleep" is the biggest risk factor for the development of widespread pain in older adults. Widespread pain that affects different parts of the body – the main characteristic of fibromyalgia – affects 15 percent of women and 10 percent of men over age 50, according to previous studies. To identify the triggers of such widespread pain, British researchers compiled demographic data as well as information on the pain and physical and mental health of more than 4,300 adults older than 50. About 2,700 had some pain at the study's start, but none had widespread pain. The results, published Feb. 13 in Arthritis & Rheumatology, show that restless sleep as well as anxiety, memory problems and poor health play a role in the development of this type of pain. Three years after the ... Read more

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FDA Advisers Revisit Heart Risks Posed by Painkillers

Posted 10 Feb 2014 by Drugs.com

MONDAY, Feb. 10, 2014 – Naproxen – the key pain reliever in Aleve – seems safer for the heart than other popular anti-inflammatory drugs such as ibuprofen (Advil and Motrin), U.S. health officials say. And it's possible that labeling will soon reflect that finding. Advisers to the U.S. Food and Drug Administration are meeting Monday and Tuesday to discuss cardiac risks associated with non-steroidal anti-inflammatory drugs, sometimes called NSAIDs. Millions of people take these medicines, which also include the prescription drug Celebrex, to relieve muscle aches, headaches and pain from arthritis and injuries. Since 2005, labeling laws have required a heart warning on these anti-inflammatory drugs. That stemmed from Merck's withdrawal of the NSAID Vioxx from the market in 2004 because of a notable increased risk of heart attack among Vioxx users. But naproxen doesn't seem to carry the ... Read more

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FDA Medwatch Alert: Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

Posted 14 Jan 2014 by Drugs.com

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.   Cases of severe liver injury with acetaminophen have occurred in patients who: • took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; • took more than one acetaminophen-containing product at the same time; or • drank alcohol while taking a ... Read more

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Many Women Suffer Persistent Pain After Mastectomy

Posted 14 Nov 2013 by Drugs.com

THURSDAY, Nov. 14 – Although breast cancer treatments have dramatically improved outcomes for women with the disease, ongoing pain continues to trouble many survivors long after they undergo a mastectomy, a new study finds. In conducting the study, researchers examined 611 women who had a partial or total mastectomy to determine which factors contributed to their pain following the surgery. Those factors included tumor size, stress or demographics. The women had also received chemotherapy and radiation with or without hormone therapy. One-third of the women reported persistent pain in their breast, underarm, side or arm that had not improved in the three years following their surgery. Researchers Dr. Inna Belfer, an associate professor of anesthesiology at the University of Pittsburgh, and her colleagues found no evidence that the type of mastectomy a woman had, the size of her tumor ... Read more

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Always Ask a Vet Before Giving Painkillers to Pets, Expert Says

Posted 7 Nov 2013 by Drugs.com

THURSDAY, Nov. 7 – When people feel pain, they often reach for common medicines such as aspirin or Motrin. These types of drugs, known as NSAIDs, also are used to treat arthritis pain in dogs and to manage pain after surgery in dogs and cats. But NSAID use in pets carries risks as well as benefits. And all dogs and cats should have a thorough physical exam by a veterinarian – including a review of the pet's medical history – before being given NSAIDs , according to the U.S. Food and Drug Administration. Pet owners also need to be informed about possible side effects, including those that could signal danger. Some of the most common side effects of NSAIDs (nonsteroidal anti-inflammatory drugs) in animals reported to the FDA are vomiting, loss of appetite, reduced levels of activity and diarrhea. While your pet is taking NSAIDs, watch for these side effects as well as looking for blood ... Read more

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FDA Approves Zohydro ER, an Extended-Release, Single-Entity Hydrocodone Product

Posted 25 Oct 2013 by Drugs.com

October 25, 2013 – The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids. Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks ... Read more

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Iroko Pharmaceuticals Receives FDA Approval for Zorvolex

Posted 24 Oct 2013 by Drugs.com

Philadelphia, Pennsylvania, October 18, 2013 - Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults[i]. Zorvolex was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. FDA approval of Zorvolex was supported by data from a Phase 3 multi-center, randomized study in which patients treated with Zorvolex reported significant pain relief compared with patients receiving placebo[ii]. “The approval of Zorvolex is important news for patients and for physicians who need new options for effective pain relief, and is a significant milestone for Iroko,” said John Vavricka, ... Read more

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meclofenamate, aspirin/diphenhydramine, aspirin/codeine, acetaminophen/caffeine/phenyltoloxamine, acetaminophen/caffeine/phenyltoloxamine/salicylamide, acetaminophen/dextromethorphan, acetaminophen/caffeine/magnesium salicylate/phenyltoloxamine, acetaminophen/aspirin/caffeine/salicylamide, acetaminophen/aluminum hydroxide/aspirin/caffeine/magnesium hydroxide, acetaminophen/aspirin, acetaminophen/dextromethorphan/doxylamine, acetaminophen/diphenhydramine, aspirin/caffeine/dihydrocodeine, aspirin/caffeine/salicylamide, aspirin/carisoprodol/codeine, aluminum hydroxide/aspirin/calcium carbonate/magnesium hydroxide, alfentanil, acetaminophen/guaifenesin, acetaminophen/phenyltoloxamine/salicylamide, bupivacaine liposome, capsaicin/lidocaine/menthol/methyl salicylate, Febrol Solution, EC-Naprosyn, Duraclon, Children's Silapap, Mapap Children's, Tolectin DS, Tolectin 600, Capital w/Codeine, Medi-Seltzer, Hycet, Dolagesic, Hydrocet, Buffasal, Astramorph PF, Farbital, Xylocaine Topical, Numorphan, Percocet 7.5/500, Aceta w/ Codeine, Mapap, Tylenol 8 Hour, Genapap, Tylophen, Dolorex, Duraxin, Aspiritab, IBU, LMX 5, Infumorph, Percocet 2.5/325, Lidosense 5, Oruvail, Combunox, Indocin SR, Panamax 240, Paralgin, Acetylsalicylic Acid, Zero-Order Release, YSP Aspirin, Norwich Aspirin, Stanback Analgesic, Bufferin Extra Strength, Therapy Bayer, Aspirin Lite Coat, Duragesic-75, Rescudose, Morphine Rapi-Ject, Doloral, Roxanol 100, Duramorph PF, Ionsys, Hydrostat IR, Entaprin, Tri-Buffered Aspirin, Halfprin, Empirin, Bayer Plus, Sloprin, Vanatrip, Mapap Rapid Tabs, Tolectin, Buffex, Ecotrin Maximum Strength, Genprin, Litecoat Aspirin, Minitabs, Gennin-FC, Genacote, Entercote, Extra Strength Bayer, Doloral Sirop, Morphitec, Numorphan HCl, Magan, Mobidin, Rid-A-Pain, Outgro Pain Relief, LTA Pediatric Kit, LTA II Kit, Nuprin Backache Caplet, Vistazine, Dolorac, RT Capsin, Trixaicin HP, Sucrets, Wild Cherry, Sarna Ultra, Tronothane, Prax, LTA Preattached 360 Kit, Senatec, Anestacon, Lidomar, Xylocaine 10% Oral, PP-Cap, Endocodone, M-Oxy, ETH-Oxydose, Dermaflex, Medi-Quik Spray, LMX 4 with Tegaderm, LMX 4, Laryng-O-Jet Spray, LMX Plus, Ela-Max 5, Protech First Aid Stik, Ela-Max, Paralyoc, Paracetamol Zydus, Pain Clear Paracetamol, Setamol, Paraspen Drops, Sigma Pain Relief, Pharmore Paracetamol, Panadol Gel Caps, Pacimol Caplets, Panadol Colourfree Drops, Pharmaction Paracetamol, Febridol Infant Drops, Accidental Rapatabs, Lemsip Headcold, Sigma Paracetamol, Paracetamol Soluble, Hexal Comfarol, Panadol Extend, Priceline Paracetamol, Paracare, Cuprofen for Children, Mandanol Infant, Mandanol 6+, Silapap Infants, Parmol, Parahexal, Febridol, Duatrol SR, Mapap Meltaway, Panadol Gel Tabs, Panadol Mini Caps, Pharmacist Paracetamol, Promax, Dymadon, Mapap Arthritis Pain, Paraspen, Lemsip Original, Bydol, Paracetamol Almus, Paracetamol Arrow, Paracetamol Biogaran, Expandox, Efferalganodis, Efferalgan, Efferalgan Pediatrique, Paracetamol EG, Paracetamol Ivax, Paracetamol Sandoz, Paracetamol Teva, Paracetamol Winthrop, Paracetamol RPG, Paracetamol Ranbaxy, Paracetamol Merck, Paracetamol Qualimed, Dolotec, Dolko Enfants, Rex Paracetamol, Paineze Paracetamol, Panamol, Panadol Soluble, Panadol Rapid Handipak, Chem Mart Chemadol, Benylin Sore Throat, Tempol, Taminol, Doliprane Sans Sucre, Dolitabs, Dolko, Doliprane Adultes, Doliprane, Claradol, Dafalgan, Capsin