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FDA Medwatch Alert: Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up

Posted 1 day 15 hours ago by Drugs.com

ISSUE: Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength. Consumers who intentionally avoid using Ibuprofen due to allergy, or other medical conditions, are advised that they may have inadvertently purchased Ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall. BACKGROUND: The recalled Assured ... Read more

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FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)

Posted 7 days ago by Drugs.com

October 17, 2014 – The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an 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. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed. Embeda has properties that are expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted. Embeda works by releasing only the morphine in the capsu ... Read more

Related support groups: Pain, Embeda, Morphine/naltrexone

Anesthetic During Breast-Removal Surgery May Reduce Long-Term Pain

Posted 11 days ago by Drugs.com

MONDAY, Oct. 13, 2014 – Giving a common local anesthetic to women undergoing breast removal surgery – a mastectomy – reduces their risk of persistent pain after the procedure, a new study says. More than two-thirds of mastectomy patients experience chronic pain after surgery, which can significantly affect physical activity, physical and mental health, and quality of life. The pain also increases the risk of depression, sleep problems and use of anti-anxiety drugs, according to the authors of the study. "Unfortunately, chronic pain is a condition that many breast cancer patients endure after mastectomy," said lead author Dr. Mohamed Tiouririne, associate professor of anesthesiology at the University of Virginia. "Our findings indicate that intravenous (IV) lidocaine can protect mastectomy patients from developing chronic pain, possibly due to the anti-inflammatory effects associated ... Read more

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FDA Medwatch Alert: Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling

Posted 17 days ago by Drugs.com

ISSUE: Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product. BACKGROUND: Ketorolac Tromethamine Injection, USP, 30mg/mL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial. The lot numbers being recalled  - MP5021, MP5024 and MP5025 - were distributed to hospitals, wholesalers and distributors nationwide from S ... Read more

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Most Who Abuse Painkillers Are Unprepared If Overdose Strikes: Study

Posted 2 Oct 2014 by Drugs.com

THURSDAY, Oct. 2, 2014 – Although teens and young adults who abuse prescription painkillers face a high risk of overdose, most don't know how to respond when one occurs, new research shows. At issue is the increasingly popular, non-medicinal use of legal prescription narcotic pain medications, including so-called "opioids" such as Oxycontin and Vicodin. Such drugs can substantially slow or even halt the ability to breath, sometimes leading to death. And while safe and effective interventions are available (including the prescription medication naloxone), the new study found that most narcotic abusers are unaware of their options. "What we found is that when it comes to how to handle an overdose, prescription opioid users who weren't using drugs for official medical reasons were less savvy than, say, more traditional heroin-using populations," said study author David Frank, a doctoral ... Read more

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Acupuncture May Not Help Chronic Knee Pain, Study Finds

Posted 30 Sep 2014 by Drugs.com

TUESDAY, Sept. 30, 2014 – Acupuncture doesn't improve knee pain any more than "sham" acupuncture, according to a new study. "Among patients older than 50 years with moderate to severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function," the study authors wrote. "Our findings do not support acupuncture for these patients." Sham acupuncture is any form of fake acupuncture, used so that researchers can test whether benefits from the traditional acupuncture may be due to a placebo effect. A placebo effect means a person believes his symptoms have improved despite receiving a fake medication or treatment. "Subjective measurements such as pain are particularly subject to placebo responses," said study co-author Kim Bennell, a professor of physiotherapy at the University of Melbourne in Australia. "This can be attributed to factors such as ... Read more

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Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

Posted 25 Aug 2014 by Drugs.com

PHILADELPHIA, August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. This marks the second indication for Zorvolex, approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults1. “Given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, we are delighted to gain approval for our first SoluMatrix® NSAID for the management of osteoarthritis pain,” said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. “Iroko has already made great strides to help fill the need for low dose NSAID options in patie ... Read more

Related support groups: Pain, Osteoarthritis, Diclofenac, Zorvolex

U.S. to Tighten Access to Certain Narcotic Painkillers

Posted 21 Aug 2014 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

Related support groups: Pain, Oxycodone, Chronic Pain, Severe Pain, Naloxone

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

Related support groups: Pain, Postoperative Pain

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Advil Childrens, Advil Junior Strength, Saleto-600, Saleto-400, Menadol, Saleto-200, Genapap Extra Strength, Redutemp, Medinol Paediatric, Medinol Under 6, Alvedon, Calpol Paediatric, Paldesic, Disprol Paracetamol, Galpamol, Calpol Fastmelts, Calpol Six Plus, Miradol, Panadol ActiFast, Umphamol, Mandanol, Hedex, Medinol Over 6, Anadin Paracetamol, Calpol Infant, Infadrops, St Joseph Aspirin-Free, Liquiprin, Actamin, Ed-APAP, Dolono Infant, Uniserts, Silapap Childrens, Adprin B, Tempra Quicklets, Junior Strength Tylenol, Elixsure Fever/Pain, Acetaminophen-odan, Atasol Forte, Tycolene, Atasol, Hydrocet, Dolagesic, choline salicylate/magnesium salicylate, diphenhydramine/ibuprofen, diphenhydramine/magnesium salicylate, camphor/menthol, benzocaine/dextromethorphan, aspirin/hydrocodone, aspirin/meprobamate, dyclonine, ibuprofen/oxycodone, aspirin/dextromethorphan/phenylephrine, morphine/naltrexone, bupivacaine liposome, rofecoxib, pentafluoropropane/tetrafluoroethane, meclofenamate, morphine liposomal, 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, capsaicin/lidocaine/menthol/methyl salicylate, acetaminophen/magnesium salicylate, Mapap Children's, Children's Silapap, Febrol Solution, Tolectin 600, Tolectin DS, Percocet 7.5/500, Numorphan, EC-Naprosyn, Duraclon, Astramorph PF, Buffasal, Hycet, Xylocaine Topical, Farbital, Capital w/Codeine, Medi-Seltzer, Infumorph, LMX 5, Tylophen, Genapap, Aceta w/ Codeine, Duraxin, Dolorex, naloxone/oxycodone, diphenhydramine/naproxen, Mapap, Tylenol 8 Hour, Oruvail, Lidosense 5, Indocin SR, Combunox, Aspiritab, IBU, Remedol, Panamax 240, 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, Rid-A-Pain, Numorphan HCl, Magan, Outgro Pain Relief, LTA II Kit, LTA Preattached 360 Kit, LTA Pediatric Kit, Mobidin, Nuprin Backache Caplet, Sucrets, Wild Cherry, Dolorac, RT Capsin, Sarna Ultra, Prax, Vistazine, Tronothane, Senatec, Laryng-O-Jet Spray, Anestacon, Lidomar, Xylocaine 10% Oral, PP-Cap, Endocodone, M-Oxy, ETH-Oxydose, Dermaflex, Medi-Quik Spray, LMX 4 with Tegaderm, LMX 4, 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, Geluprane, Expandox, Efferalgan Pediatrique, Efferalganodis, 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, Dolitabs, Dolko, Doliprane Sans Sucre, Doliprane Adultes, Dafalgan, Doliprane, Trixaicin HP