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U.S. to Tighten Access to Certain Narcotic Painkillers

Posted 1 day 11 hours ago by Drugs.com

THURSDAY, Aug. 21, 2014 – The U.S. Drug Enforcement Administration (DEA) is going ahead with tough new controls on painkillers containing hydrocodone, which has been tied to a surge in dangerous addictions across the United States. The new restrictions would cover prescription narcotic drugs such as Vicodin, Lortab and their generic equivalents, putting them in the same regulatory class as painkillers such as Oxycontin, Percocet and codeine. Patients will now only have access to a three-month supply of the drug and will have to see a doctor to get any refills. The new rules, posted online by the DEA on Thursday, come more than 18 months after a U.S. Food and Drug Administration advisory panel met to discuss the fate of painkillers containing hydrocodone. That 2013 meeting followed the DEA's request for an FDA panel review on the issue. The painkillers were previously classified as ... Read more

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FDA Approves Targiniq ER Hard-to-Abuse Narcotic Painkiller

Posted 25 Jul 2014 by Drugs.com

THURSDAY, July 24, 2014 – A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration. Called Targiniq ER and made by Purdue Pharma, the pill is a combination of the narcotic oxycodone and naloxone, a drug that blocks the euphoric effects of oxycodone. The naloxone is only activated when the pill is crushed, snorted, dissolved or injected, according to the FDA. While Targiniq has only been approved for patients who have chronic pain that has not responded to other medications, the FDA acknowledged the medication can still be abused simply by taking too many pills. Currently, that is the most common way oxycodone is misused. Experts made the same point. "When the pills are swallowed they are as addictive and dangerous as pure oxycodone," Andrew Kolodny, chief medical ... Read more

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Targiniq ER Tough-to-Abuse Formulation of Oxycodone Approved

Posted 25 Jul 2014 by Drugs.com

THURSDAY, July 24, 2014 – Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other therapies are ineffective or unavailable. The long-acting form of oxycodone, an opioid painkiller, has properties that are designed to deter abuse of the drug by snorting or injection, the FDA said in a news release. Targiniq contains naloxone, designed to block the euphoric effects of oxycodone, the agency said. Targiniq can still be abused by taking too many pills, the FDA warned, stressing that an overdose could cause death. The drug is not meant for as-needed pain relief, the agency said, repeating its warning of the potential for abuse and addiction. Targiniq ER was evaluated in a clinical study of 601 people with chronic lower back pain. The most ... Read more

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FDA Approves Targiniq ER Extended-Release Oxycodone with Abuse-Deterrent Properties

Posted 23 Jul 2014 by Drugs.com

July 23, 2014 – Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) 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. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers th ... Read more

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Could 'Phone Care' Ring in New Approach to Pain Relief?

Posted 15 Jul 2014 by Drugs.com

TUESDAY, July 15, 2014 – Relief for chronic pain may be just a phone call away, according to a new study. Pain is a major health problem in the United States and costs the country more than $600 billion each year in lost productivity and health care. For this study, published in the July 16 issue of the Journal of the American Medical Association, researchers evaluated telephone-delivered care within a group of 250 people with chronic musculoskeletal pain. Participants were randomly assigned to receive either usual care from their primary care doctors or "telecare" management, which included automated symptom monitoring and use of pain medications guided by scientific methods. After 12 months, more than half the patients in the telecare group reported at least a 30 percent improvement in their pain score, compared with about one-quarter of those in the usual-care group, the study ... Read more

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Prescriptions for Powerful Painkillers Vary Widely Among States: CDC

Posted 1 Jul 2014 by Drugs.com

TUESDAY, July 1, 2014 – Doctors in some states seem to wield a freer hand issuing prescriptions for powerful narcotic medications, leading to wide variations in narcotic drug use among states, U.S. health officials reported Tuesday. Physicians in Alabama – the state with the highest number of narcotic painkiller prescriptions – issued nearly three times as many of those prescriptions as doctors in Hawaii – the lowest prescribing state, according to researchers with the Centers for Disease Control and Prevention. "The bottom line is we're not seeing consistent, effective, appropriate prescribing of painkillers across the nation, and this is a problem because of the deaths that result," Dr. Tom Frieden, director of the CDC, said at a news conference. Frieden added that every day 46 people die from an overdose of prescription painkillers. Overall, health-care providers wrote 259 ... Read more

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Use Prescription Painkillers Safely

Posted 8 Jun 2014 by Drugs.com

FRIDAY, June 6, 2014 – Powerful prescription painkillers known as opioids are often involved in accidental overdoses, so experts offer tips on how to take these highly addictive medications safely. "Prescription painkiller misuse is a growing epidemic. However, most people who abuse these drugs are struggling with an addiction they never intended to have," said John Ulczycki, vice president of strategic initiatives at the National Safety Council. "This National Safety Month, we hope to educate Americans on proper use so they can relieve pain without the tragic consequences of drug dependence or death." Dr. Don Teater, a medical advisor at the National Safety Council provided the following five tips to help ensure the safe use of prescription painkillers: Consider other options. Talk to your doctor about other medications that may be more effective in controlling your pain. In most ... Read more

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Men Feel More Pain After Major Surgeries, Study Finds

Posted 3 Jun 2014 by Drugs.com

TUESDAY, June 3, 2014 – Gender may play a part in how much pain a patient feels following surgery, new research suggests. An Austrian study involving more than 10,000 people found that men experience more pain after major surgery, while women report feeling more pain following minor procedures, such as biopsies. "The influence of gender and sexes is a key issue of today's research in medicine. However, current literature in the field of perioperative medicine rarely focuses on this question," study co-author Dr. Andreas Sandner-Kiesling, of the department of anesthesiology & intensive care at the Medical University of Graz, Austria, said in a university news release. "Our aim was to analyze a large population to find differences in postoperative pain perception in females and males," Sandner-Kiesling explained. The patients involved in the four-year study were interviewed 24 hours ... Read more

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FDA Medwatch Alert: Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems

Posted 23 Apr 2014 by Drugs.com

Including methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone [Posted 04/23/2014] ISSUE: FDA is warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The injections are given to treat neck and back pain, and radiating pain in the arms and legs. The effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use.  FDA is requiring the addition of a Warning to the drug labels of injectable corticosteroids to describe these risks. BACKGROUND: To raise awareness of the risks of epidural corticosteroid injections in the medical community, FDA’s Safe Use Initiative convened a panel of experts, including pain management experts to help define the te ... Read more

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Too Much Codeine Still Prescribed to U.S. Kids: Study

Posted 21 Apr 2014 by Drugs.com

MONDAY, April 21, 2014 – Emergency room physicians still hand out hundreds of thousands of codeine prescriptions for children every year, despite warnings that kids' responses to codeine vary wildly and the drug can cause an accidental overdose, a new study finds. ER doctors issued about 560,000 to 880,000 prescriptions for codeine to kids each year between 2001 and 2010, according to an analysis of hospital survey data collected annually by the U.S. Centers for Disease Control and Prevention. "We have hundreds of thousands of children still getting codeine, even though there are better and safer alternatives available," said study author Dr. Sunitha Kaiser, an assistant clinical professor of pediatrics at the University of California, San Francisco (UCSF). The study was published online April 21 in the journal Pediatrics. These prescriptions continued to be handed out despite repeated ... Read more

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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

Related support groups: Pain, Hydrocodone

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Saleto-600, Saleto-800, Saleto-200, Menadol, Haltran, IBU-200, Conacetol, Dolono, Calpol Paediatric, Medinol Paediatric, Medinol Under 6, Paldesic, Galpamol, Calpol Infant, Disprol Paracetamol, Alvedon, Calpol Fastmelts, Mandanol, Miradol, Panadol ActiFast, Hedex, Anadin Paracetamol, Calpol Six Plus, Medinol Over 6, Infadrops, Elixsure Fever/Pain, Dolono Infant, Ed-APAP, St Joseph Aspirin-Free, Silapap Childrens, Uniserts, Genapap Extra Strength, Redutemp, Liquiprin, Actamin, Atasol Forte, Acetaminophen-odan, Junior Strength Tylenol, Atasol, Tycolene, Adprin B, Tempra Quicklets, Hycet, Buffasal, camphor/menthol, choline salicylate/magnesium salicylate, diphenhydramine/ibuprofen, benzocaine/dextromethorphan, aspirin/oxycodone, aspirin/hydrocodone, aspirin/meprobamate, diphenhydramine/magnesium salicylate, dyclonine, rofecoxib, aspirin/dextromethorphan/phenylephrine, morphine/naltrexone, pentafluoropropane/tetrafluoroethane, morphine liposomal, ibuprofen/oxycodone, 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, Tolectin DS, Tolectin 600, Mapap Children's, Numorphan, Percocet 7.5/500, Infumorph, Percocet 2.5/325, Children's Silapap, Febrol Solution, Farbital, Xylocaine Topical, Astramorph PF, Medi-Seltzer, Capital w/Codeine, EC-Naprosyn, Duraclon, LMX 5, Lidosense 5, Duraxin, Tylophen, Genapap, Dolorex, diphenhydramine/naproxen, acetaminophen/magnesium salicylate, naloxone/oxycodone, Aceta w/ Codeine, Mapap, Indocin SR, Oruvail, Combunox, IBU, Tylenol 8 Hour, Aspiritab, Umphamol, Remedol, Stanback Analgesic, Norwich Aspirin, Acetylsalicylic Acid, Therapy Bayer, Bufferin Extra Strength, Tri-Buffered Aspirin, Entaprin, Zero-Order Release, YSP Aspirin, Duramorph PF, Roxanol 100, Rescudose, Hydrostat IR, Ionsys, Aspirin Lite Coat, Duragesic-75, Minitabs, Litecoat Aspirin, Vanatrip, Sloprin, Halfprin, Tolectin, Mapap Rapid Tabs, Paracetamol Zydus, Paralyoc, Empirin, Bayer Plus, Genacote, Gennin-FC, Genprin, Extra Strength Bayer, Entercote, Buffex, Ecotrin Maximum Strength, Morphine Rapi-Ject, Doloral, Outgro Pain Relief, Rid-A-Pain, Numorphan HCl, LTA II Kit, LTA Pediatric Kit, Senatec, LTA Preattached 360 Kit, Magan, Mobidin, Sarna Ultra, Sucrets, Wild Cherry, Dolorac, Prax, Tronothane, Nuprin Backache Caplet, Vistazine, Laryng-O-Jet Spray, LMX 4, Endocodone, PP-Cap, Anestacon, ETH-Oxydose, M-Oxy, Doloral Sirop, Morphitec, Lidomar, Xylocaine 10% Oral, Ela-Max 5, LMX Plus, LMX 4 with Tegaderm, Ela-Max, Protech First Aid Stik, Dermaflex, Medi-Quik Spray, Paracetamol Winthrop, Paracetamol Teva, Sigma Pain Relief, Pain Clear Paracetamol, Setamol, Pharmore Paracetamol, Pacimol Caplets, Priceline Paracetamol, Panadol Gel Caps, Paraspen Drops, Panadol Colourfree Drops, Sigma Paracetamol, Febridol Infant Drops, Accidental Rapatabs, Paracetamol Soluble, Panadol Extend, Pharmaction Paracetamol, Hexal Comfarol, Paracare, Pharmacist Paracetamol, Silapap Infants, Cuprofen for Children, Mandanol Infant, Parmol, Febridol, Panamax 240, Parahexal, Mandanol 6+, Duatrol SR, Promax, Panadol Gel Tabs, Panadol Mini Caps, Dymadon, Paraspen, Mapap Meltaway, Mapap Arthritis Pain, Lemsip Headcold, Lemsip Original, Expandox, Geluprane, Paracetamol Almus, Efferalganodis, Efferalgan Pediatrique, Dolko Enfants, Dolotec, Paracetamol Arrow, Paracetamol Biogaran, Paracetamol Ranbaxy, Paracetamol RPG, Paracetamol Sandoz, Paracetamol Qualimed, Paracetamol Merck, Paracetamol EG, Paracetamol Ivax, Dolko, Dolitabs, Panadol Soluble, Rex Paracetamol, Paineze Paracetamol, Panadol Rapid Handipak, Benylin Sore Throat, Bydol, Chem Mart Chemadol, Panamol, Tempol, Doliprane Adultes, Doliprane Sans Sucre, Doliprane, Dafalgan, Taminol, Claradol, RT Capsin