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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 9 days ago by Drugs.com

[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

Related support groups: Pain, Tylenol, Acetaminophen, Ibuprofen, Naproxen, Advil, Aleve, Paracetamol, Motrin, Panadol, Naprosyn, Naprelan, Naprelan '375', Panadol Osteo, Tylenol Extra Strength, Q-Pap, Tylenol Arthritis Caplet, Childrens Tylenol, Acetaminophen Quickmelt, Anaprox

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

Posted 30 Dec 2014 by Drugs.com

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 Drugs.com

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

Related support groups: Pain, Suboxone, Tramadol, Oxycodone, Methadone, Percocet, Hydrocodone, OxyContin, Vicodin, Morphine, Norco, Fentanyl, Lortab, Codeine, Opana, Subutex, Dilaudid, Ultram, Opana ER, Nucynta

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

Posted 25 Nov 2014 by Drugs.com

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 Drugs.com

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 Drugs.com

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

Related support groups: Pain, Depression, Surgery

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

Posted 22 Oct 2014 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 17 Oct 2014 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

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

Posted 13 Oct 2014 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

Related support groups: Pain, Surgery, Breast Cancer, Lidocaine, Xylocaine, Nervocaine, UAD Caine, Anestacaine, Xylocaine Duo-Trach Kit, L-Caine, Xylocaine HCl For Spinal, Lidoject 2, Truxacaine, Dilocaine, DentiPatch, Xylocaine HCl, Lidoject 1, Xylocaine-MPF

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

Posted 6 Oct 2014 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

Related support groups: Pain, Toradol, Ketorolac, Sprix, Toradol IV/IM, Toradol IM

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

Related support groups: Pain, Oxycodone

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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, Tolectin 600, Mapap Children's, Children's Silapap, Tolectin DS, Numorphan, Infumorph, Percocet 7.5 / 500, Febrol Solution, EC-Naprosyn, Xylocaine Topical, Astramorph PF, Buffasal, Farbital, Medi-Seltzer, Duraclon, Capital w / Codeine, LMX 5, Lidosense 5, Duraxin, Tylophen, Genapap, Dolorex, acetaminophen / aspirin / diphenhydramine, naloxone / oxycodone, diphenhydramine / naproxen, Aceta w / Codeine, Mapap, Indocin SR, Oruvail, Combunox, IBU, Tylenol 8 Hour, Aspiritab, Umphamol, Remedol, 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, 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, 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, Panadol Soluble, Rex Paracetamol, Paineze Paracetamol, Panadol Rapid Handipak, Benylin Sore Throat, Bydol, Chem Mart Chemadol, Panamol, Tempol, Dolitabs, Dolko, Doliprane Sans Sucre, Doliprane Adultes, Taminol, Doliprane, Trixaicin HP