 March-April 2008; Issue 14
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Seth I. Kaufman, MD. Posting Date: April 18, 2008.
Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products.
 Access to all external URL links was checked prior to posting; however, some may change or become obsolete over time and will no longer function. This is beyond our control.
Glucosamine Unhelpful for Hip Osteoarthritis
Despite consumer support of glucosamine sulfate, there have been few studies of its effectiveness. Researchers in The Netherlands designed a controlled trial to examine its effect on the symptoms and disease progression of hip osteoarthritis during a 2-year period. Early-stage patients (n=222) who met the American College of Rheumatology clinical criteria for hip osteoarthritis were randomly assigned to once-daily treatment with 1500 mg of oral glucosamine sulfate or placebo. Primary outcome measures included pain and function scores during a 24-month period and a measure of joint space narrowing at study completion.
At the study’s end, none of the 3 outcome measures showed significant differences between treatment and placebo groups. One limitation of the study included the fact that 20 patients had a total hip replacement during the trial period.
Clinical Implications: While the results of this study failed to demonstrate any therapeutic benefit of glucosamine sulfate compared with placebo, a related news story (WebMD Medical News) reported on the reactions of other clinicians and supplement-makers who expressed concerns about the length of the study, the level of osteoarthritis disease progression in this patient population (they were at early stages), and the fact that only patients with hip joint involvement were studied.
Reference: Rozendaal RM, Koes BW, van Osch GJ, et al. Effect of glucosamine sulfate on hip osteoarthritis: a randomized trial. Ann Intern Med. 2008(Feb 19);148(4):268-277.
 Read the WebMD HTML news story available at:
http://www.medicinenet.com/script/main/art.asp?articlekey=87245 (access checked 4/9/08).
Other studies reported by Pain Treatment Topics also have questioned the effectiveness of the supplement glucosamine, as well as chondroitin, for the pain of osteoarthritis. See:
http://pain-topics.org/news_research_updates/issue9.php#glucosamine
http://www.pain-topics.org/news_research_updates/premiere.php#joint
http://www.pain-topics.org/news_research_updates/issue8.php#chondroitininneffective
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Injury-Related Pain Can Persist for a Year
Investigators at the University of Washington in Seattle analyzed data from nearly 70 hospitals across the United States to evaluate the presence of chronic pain one year following injury. Several different personal-, injury-, and treatment-related factors were examined in 3047 patients who were hospitalized for trauma during the prior year.
As measured by the Chronic Pain Grade Scale, almost 63% of patients had injury-related pain that persisted for 12 months with most of them reporting pain in more than one body region. Almost 60% had 3 or more painful areas, while 37% had a single painful area. The average measurement for severity of pain in the final month was 5.5 on a 10-point scale. Patients most likely to report pain one year after injury were 35-44 years of age and pain was more common in women and patients who had untreated depression before injury; patients aged 75-84 were least likely to have pain. Pain at 3 months post-injury was predictive of both the presence and higher severity of pain at 12 months.
Clinical Implications: In a related news story (HealthDay News), the authors stated “the findings of this study suggest that interventions to decrease chronic pain in trauma patients are needed.” They further added that the high prevalence of pain and its severity suggest that “interventions during the acute phase of hospitalization to aggressively treat early pain and better manage neuropathic pain” may be warranted. Based on an existing theory which suggests that the undertreatment of acute pain may increase the possibility of a pain cascade facilitating neural remodeling and hypersensitization, acute pain may need to be managed more aggressively.
Reference: Rivara FP, Mackenzie EJ, Jurkovich GJ, et al. Prevalence of pain in patients 1 year after major trauma. Arch Surg. 2008(Mar);143(3):282-288.
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New AHA Guidelines For Cocaine-Related Chest Pain
 Because symptoms of cocaine use can mimic those of myocardial infarction, new guidelines have been published for healthcare professionals by the American Heart Association (AHA) in the March 2008 edition of the journal Circulation. The AHA’s Acute Cardiac Care Committee reviewed existing literature on cocaine-associated chest pain and myocardial infarction (MI), and then classified recommendations for diagnostic and therapeutic care by level-of-evidence.
Investigators reported that there were 448,481 cocaine-related visits to emergency departments in the United States in 2005 and chest discomfort was reported 40% of cases; cardiopulmonary complaints were the most frequent symptom overall. While the research showed that only 1% to 6% of the patients with cocaine-associated chest pain actually had an MI, there are several important reasons for early identification of cocaine use:
- Symptoms of drug use – chest pain, shortness of breath, anxiety, palpitations, dizziness, nausea, heavy sweating – can be similar to those of an MI,
- Patients abusing cocaine usually can be monitored without hospital admission and the number of expensive tests to rule out an MI can be reduced, and
- Two treatments – beta-blockers and thrombolytic therapy – typically used to treat an MI can be dangerous in cocaine users.
The guidelines recommend early identification of cocaine use by self-report or by laboratory testing. Beyond echocardiography, recommendations for further diagnostic testing are based on specific symptoms. Therapeutic strategies for cocaine-associated chest pain, unstable angina, or MI are similar to those for patients with traditional (or potential) acute coronary syndrome.
Practice Pointers: This guideline is essential for all healthcare providers because it is important to identify the cause of chest pain early in the diagnostic process and prior to treatment. Being unaware of a patient’s cocaine use could mean that drugs administered for the treatment of an MI could be dangerous to someone who has drug-related symptoms. Two of the studies reviewed reported that the majority of patients with cocaine-associated MI events were an average age of 38 and 44 years of age, respectively. Furthermore, a higher percentage of patients in both studies having cocaine-related MI events were nonwhite and cigarette smokers when compared with patients experiencing an MI without recent cocaine use.
Reference: McCord J, Jneid H, Hollander JE, et al. Management of Cocaine-Associated Chest Pain and Myocardial Infarction. Circulation. 2008(Mary 17); Early online publication prior to print.
 The full-text of the AHA scientific statement (12 pp) can be downloaded at: http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.107.188950v1 (access checked 4/4/08).
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Pregabalin May Reduce Refractory Neuropathic Pain
Patients with neuropathic pain – such as that associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) – may not always respond to standard treatments and the pain can become intractable. This 15-month open-label study evaluated pregabalin, an anticonvulsant medication also indicated for relief of neuropathic pain, in patients whose pain was considered refractory to other treatments. Patients (n=81) with moderate to severe neuropathic pain were treated with 5 cycles of flexible-dose pregabalin 150-600 mg/day for 3-month periods. Each treatment period was followed by a 3- to 28-day pregabalin-free “holiday.” Pain was measured using a visual analog scale.
Researchers reported that pregabalin 150-600 mg/day demonstrated clinically meaningful and sustained pain relief during each treatment cycle, with pain recurrence during pregabalin “holidays.” Pain relief improved during the next cycle when pregabalin therapy was reinstated.
Practice Pointers: The authors conclude that pregabalin may be beneficial for pain relief in patients who have neuropathic pain and have not achieved satisfactory response with other medications. Similarly, the results of a study of pregabalin for pain relief in trigeminal neuralgia showed beneficial results and has been reported previously by Pain Treatment Topics, see:
http://pain-topics.org/news_research_updates/issue12.php#Pregabalin.
 Caution: According to a recent FDA analysis, pregabalin is one of 11 antiepileptic drugs that have shown almost twice the risk of suicidal behavior or suicidal ideation when compared with patients receiving placebo. For further information, see the FDA alert at: http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm (access checked 4/9/08).
Reference: Stacey BR, Dworkin RH, Murphy K, et al. Pregabalin in the treatment of refractory neuropathic pain: results of a 15-month open-label trial. Pain Med. 2008(Mar 11); Early online publication prior to print.
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Pediatric Trauma: Prehospital Pain Interventions Lacking
Researchers in Ohio retrospectively reviewed 696 charts of injured children from the years 2002-2004 to analyze pain-assessment documentation and pain management interventions in prehospital settings. This investigation showed that pain was noted in almost 65% of patients, although only one chart reported the appropriate use of a validated pain assessment tool. The statement “no pain” was noted in 17% of cases, but almost 19% of patient charts did not have any documentation related to pain. No pain interventions were documented on almost 87% of charts, including most of the charts (85%) for injured children with documented pain. Overall, only about 13% of cases received pain interventions — including drugs, traction, splinting, saline flush and dressing, and/or distraction techniques.
Clinical Implications: In addition to the lack of pain assessment documentation, the researchers expressed concern about apparent laxity in the implementation of pain-control interventions for injured children in the prehospital setting. They further recommend an increase in pain-control education for prehospital healthcare providers.
Reference: Izsak E, Moore JL, Stringfellow K, et al. Prehospital pain assessment in pediatric trauma. Prehosp Emerg Care. 2008(Apr-Jun);12(2):182-186.
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Buprenorphine Overdose in Young Children Reviewed
A retrospective review of buprenorphine overdose in children, as reported by United States poison centers, was published in the April issue of the journal Pediatrics. Buprenorphine is an opioid partial agonist used as an analgesic and in the treatment of opioid dependence. Of the 86 buprenorphine overdoses in children under 6 years of age reported between November 2002 and December 2005, 54 children developed toxicity.
The primary symptoms included drowsiness or lethargy (55%), vomiting (21%), constriction of the pupil of the eye (21%), and respiratory depression (7%); less frequent symptoms included agitation or irritability, pallor, and coma. The mean time to onset of effects was about 65 minutes (range 20 minutes – 3 hours). While the length of clinical effects varied greatly, almost 60% had effects lasting 2 to 8 hours. All children who ingested >4 mg of buprenorphine experienced some effect but no child ingesting less had severe effects. Naloxone was administered to 22 children and 67% had at least a partial response to the treatment.
Clinical Implications: The investigators conclude that, in many cases, buprenorphine overdoses in children may not be associated with severe adverse events. There were no deaths and only 7% experienced significant central nervous system and respiratory depression. They further recommend that any child ingesting more than 2 mg of the drug and children less than 2 years of age who have ingested more than a lick or taste should be referred to the emergency department for an observation period of at least 6 hours.
Reference: Hayes BD, Klein-Schwartz W, Doyon S. Toxicity of buprenorphine overdoses in children. Pediatrics. 2008(Apr);121(4):e782-786.
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Celecoxib Improves Postop Recovery
Researchers at the University of Texas Southwestern Medical Center designed a double-blind, placebo-controlled study to evaluate the analgesic effectiveness of celecoxib preoperatively, postoperatively, and 3 days after major plastic surgery. Patients (n=120) undergoing plastic surgery (eg, breast augmentation, abdominoplasty procedures) with a standardized general anesthetic technique were randomized equally to one of 3 treatment groups:
- Control Group – received 2 placebos orally before and after surgery, plus one placebo twice daily for 3 days after surgery,
- Postoperative Group – received 2 placebos before surgery and 2 celecoxib 200 mg orally 30-90 minutes before surgery, and one celecoxib 200 mg orally twice daily for 3 days after surgery, or
- Perioperative Group – received 2 celecoxib 200 mg orally 30-90 minutes before surgery, 2 placebos after surgery, and one celecoxib 200 mg orally twice daily for 3 days after surgery.
Patients were evaluated at 24 hours, 48 hours, 72 hours, and 7 days following surgery to assess pain, analgesic requirements, return of bowel function, return to normal daily activities, and overall satisfaction with the quality of recovery. In comparison with the placebo-control group, both celecoxib groups had similarly significant reductions in postoperative pain and the need for opioid analgesics during the first 3 postoperative days (p < 0.01). Additionally, patients in the celecoxib groups resumed bowel function 1 day earlier, returned to normal activities 2 days earlier, and had a significant improvement in the quality of recovery when compared with the control group (p < 0.05). Perioperative celecoxib administration did not offer greater advantages than earlier administration on the first postoperative day.
Clinical Concept: Results of this study showed that celecoxib (400 mg orally/day) can offer recovery benefits in the postoperative period. Pain reduction, lower opioid consumption, faster bowel function recovery, and faster return to activities of daily living provide physiological, psychological, and economic benefits to the patient.
Reference: Sun T, Sacan O, White PF, et al. Perioperative versus postoperative celecoxib on patient outcomes after major plastic surgery procedures. Anesth Analg. 2008(Mar);106(3):950-958.
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Oxcarbazepine Ineffective in Preventing Migraine
The safety, tolerability, and effectiveness of oxcarbazepine (Trileptal®) as prophylactic therapy for migraine headache was evaluated in a multicenter, double-blind study and published in a February 2008 issue of the journal Neurology. Patients known to have a history of 3 to 9 migraine attacks per month were randomized to receive either oxcarbazepine 1200 mg/day (n=85) or placebo (n=85) during a 19-week trial. The primary outcome measure was a change in the number of migraine attacks during the final 28-day period of the study compared with baseline.
Results showed no significant differences between the oxcarbazepine and placebo treatment groups in the number of migraine attacks during the last 28 days. Adverse events, which were mild to moderate in severity, were reported for 80% of patients in the oxcarbazepine group and 65% of those taking placebo. The most common side effects in the oxcarbazepine-treated group were fatigue, dizziness, and nausea.
Clinical Implications: While oxcarbazepine appeared to be relatively well tolerated, this study did not show evidence that the drug is effective in preventing migraine. In a related news story (Newswise Medical News), Stephen Silberstein, MD, observed that the 3 epilepsy drugs most effective in preventing migraine – topiramate, divalproex, and gabapentin – have several mechanisms of action, including the ability to regulate the neurotransmitter GABA. He stated, “it’s possible that epilepsy drugs must be able to regulate this neurotransmitter in order to prevent migraine” [and oxcarbazepine does not have this capacity].
Reference: Silberstein SD, Saper J, Berenson F, et al. Oxcarbazepine in migraine headache: a double-blind, randomized, placebo-controlled study. Neurology. 2008(Feb 12);70(7):548-555.
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Edema Associated with Methadone Therapy
Methadone, a synthetic long-acting opioid, has become an accepted analgesic for chronic pain, and has long been used as an agent for treating opioid addiction. New York Harbor Healthcare System reports on the case of a woman aged 45 years whose treatment regimen for chronic low back pain included methadone, etodolac, and gabapentin. Within several days of treatment initiation, she reported “feeling drunk” and showed signs of edema. Etodolac and gabapentin were discontinued and the methadone dose was increased, but the edema persisted. In response, clinicians decreased the methadone dosage and a diuretic was added to treat the edema, but the symptom remained. The edema did not disappear until the patient took prednisone and an increased dose of the diuretic. Using the Naranjo adverse drug reaction probability scale, the investigators determined that the probable cause of edema was the methadone therapy.
Clinical Implications: The authors note that there have been a few previous cases of edema associated with methadone therapy reported in the literature, but that patients had been on 3 to 6 months of methadone before the edema developed. While it is an uncommon occurrence and the exact mechanism of this reaction is unknown, it is important for prescribers to know that edema in patients taking methadone has been reported. Due to the complexities of methadone dosing, the authors recommend that patients be assessed every few days in the early phase of treatment and, subsequently, with any change in dosing.
Reference: Kharlamb V, Kourlas H. Edema in a patient receiving methadone for chronic low back pain. Medscape Ob/Gyn & Women’s Health; 2008; 4 pages. Reprinted in full-text from Am J Health-Syst Pharm. 2007(Dec);64(24):2557-2560.
 Read the HTML article at: http://www.medscape.com/viewarticle/568656 (access checked 4/9/08).
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Cod Liver Oil May Offer NSAID-Sparing Benefits in RA
A double-blind placebo-controlled study by researchers in the United Kingdom evaluated the potential of cod liver oil supplements to reduce daily non-steroidal anti-inflammatory drug (NSAID) use in patients with rheumatoid arthritis (RA). Patients with RA (n=97) from 2 health centers were randomly assigned to either 10 g of cod liver oil containing 2.2 g of n-3 essential fatty acids (n-3 EFAs) or air-filled placebo capsules. Data on patients’ NSAID requirements, RA disease activity levels, and safety issues were collected at baseline and 4, 12, 24, and 36 weeks. The primary outcome measure was a relative reduction in daily NSAID use of >30%.
Almost 40% of patients in the cod liver oil group were able to comfortably reduce their daily NSAID consumption by >30%, compared with only 10% of patients in the placebo group. The 2 groups did not differ in the number of adverse effects observed or the clinical parameters of RA disease activity.
Clinical Implications: Because the potential adverse effects of NSAIDs are well-known, their limited use is recommended in the management of the chronic pain of rheumatoid arthritis. The results of this study suggest that cod liver oil supplements (containing n-3 EFAs) could allow arthritis patients to maintain pain relief while reducing their intake of NSAIDs.
Reference: Galarraga B, Ho M, Youssef HM, et al. Cod liver oil (n-3 fatty acids) as a non-steroidal anti-inflammatory drug sparing agent in rheumatoid arthritis. Rheumatology (Oxford). 2008(Mar 24); Early online publication prior to print.
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Back & Neck Pain Costs, Disability Rising
National trends in the costs and health status of adults aged 17 years and older with back and neck pain were examined by investigators at the University of Washington in Seattle. Data from the annual Medical Expenditure Panel Survey (MEPS) were examined from 1997 through 2005. Respondents with self-reported back and neck problems were recorded as “spine problems” based on MEPS descriptions and the International Classification of Diseases. Highlights of the study included the following:
- The total number of adults sampled in 1997 was 23,045 and included 3139 respondents who reported spine (back and neck) problems. Medical costs for adults with spine problems averaged $4,695 compared with $2,731 for individuals without spine problems (adjusted for inflation to 2005 dollars).
- The total number of adults sampled in 2005 was 22,258, including 3187 respondents with self-reported spine problems. Compared with 1997 data the average cost of medical expenditures rose 65% (inflation-adjusted) to $6,096 for respondents with spine problems; while those who did not have spine problems paid an average of $3,516.
- The estimated percentage of persons with self-reported physical disabilities due to spine problems rose from about 21% in 1997 to almost 25% in 2005.
- Scores on self-reported measures of mental health, physical functioning, work or school limitations, and social limitations all were worse in 2005 than in 1997 (even with age and gender adjustments).
Clinical Implications: In a related news story (HealthDay News), Brook Martin, MD, stated that the results of this study “call into question whether we’re providing treatments to people who aren’t going to benefit.” He further suggested that the increase in expenditures without evidence of corresponding improvements in self-assessed health status “suggests a need for more effectiveness studies and a look at which patients benefit from treatments and diagnostic tests.”
[Commentary: One implication of this study is that patients with spine (back/neck) problems were paying more in 2005 and receiving pain management treatments that were not more effective than those provided 8 years earlier in 1997. This is a rather disappointing perspective and it should motivate healthcare providers to examine whether they are up to date on the latest, evidence-based, and most effective strategies for dealing with these conditions. – SBL]
Reference: Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults with back and neck problems. JAMA. 2008(Feb 13);299(6):656-664.
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CRPS Incidence in Patients With Multiple Sclerosis
According to prior research, more than half of patients with multiple sclerosis (MS) also have chronic pain syndromes. Investigators in Philadelphia examined the records of a neurology clinic patient database covering a 4 year period to determine the prevalence of complex regional pain syndrome (CRPS). All patients included in the evaluation had met the 2005 revised McDonald criteria for a diagnosis of MS and no patient had been previously diagnosed with CRPS.
In a sample of 205 cases meeting inclusion criteria, 4 female patients (aged 32-51 years) met the 2005 International Association for the Study of Pain (IASP) diagnostic criteria for CRPS. This was a significantly higher rate than the 0.078 cases per 205 the authors had expected based on existing prevalence data reporting CRPS in the general population (p < 0.0001). The CRPS diagnosis was found in patients with both secondary progressive and relapsing-remitting MS.
Clinical Implications: The authors reported that this small study was the first of its kind and suggests that patients with MS have a higher risk of developing CRPS than the general population. Standard treatment protocols (eg, analgesics, antidepressants, anticonvulsants) for CRPS were used during this study and results showed no difference in treatment response among patients with MS when compared with patients having the usual peripheral traumatic etiologies for CRPS.
Reference: Schwartzman RJ, Gurusinghe C, Gracely E. Prevalence of complex regional pain syndrome in a cohort of multiple sclerosis patients. Pain Physician. 2008(Mar);11(2):133-136.
The full-text article from Pain Physician can be downloaded at: http://www.rsds.org/2/library/article_archive/pop/Schwartzman_Gurusinghe_Gracely.pdf (access checked 4/12/08).
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Recent Drug or Device Approvals and Announcements
Following are briefs on new pain-management drug or device approvals or announcements, as well as items related to safety concerns for existing products. If the FDA or DEA news websites posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.
Additionally, the FDA Center for Drug Evaluation and Research website offers the option to search on any approved drug name or active ingredient at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, and safety information is posted by FDA’s MedWatch at http://www.fda.gov/medwatch/safety/2006/safety06.htm.
ISMP “Do Not Crush List” Updated
In March 2008, the list of drugs that can cause harm to a patient if crushed, chewed, or dissolved was updated by the Institute for Safe Medication Practices (ISMP) and the University of Michigan Hospitals and Health Centers. The list includes medications from all drug classes, but it is important to note that the 3 drugs with potentially fatal events, if crushed, are all analgesics with slow release or extended-release formulation – Opana ER, OxyContin, and Ultram ER. It is important to warn patients against this potentially harmful practice even though it should be clearly marked on pharmacy prescription containers.
The full list can be downloaded at: http://www.ismp.org/Tools/DoNotCrush.pdf (access checked 4/7/08).
Etanercept (Enbrel®) – Black Box Warning Issued Regarding Infection Risk
In March 2008, Amgen Inc. and Wyeth Pharmaceuticals (marketers of Enbrel®), issued a news release to warn healthcare professionals of the risks of tuberculosis and other infections for patients who use this etanercept product. It is a fully human soluble tumor necrosis factor (TNF) receptor antagonist approved by the FDA to treat symptoms of pain and inflammation in moderate-to-severe rheumatoid arthritis. The boxed warning clarifies information related to the risk of infection and adds a patient screening recommendation for latent tuberculosis before initiating etanercept therapy. The release states that while post-marketing cases of tuberculosis reactivation have been reported for etanercept, “clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with Enbrel than with TNF-blocking monoclonal antibodies.”
The “Letter to Healthcare Professionals” can be downloaded at: http://www.enbrel.com/pdf/hcp_letter.pdf (access checked 4/8/08).
Tussionex® Pennkinetic Extended-Release Suspension – FDA Warning for Cough Product
In March 2008, the FDA alerted healthcare professionals to reports of death and life-threatening adverse events in patients who use Tussionex® (a liquid cough product that contains the opioid hydrocodone for pain and cough discomfort). The reports indicate that clinicians have prescribed the product for patients under the approved age group of “6 years old and older” and have prescribed more frequent dosing than “every 12 hours” as indicated on the product label. An overdose of Tussionex in older children, teens, and adults also has been associated with life-threatening and fatal respiratory depression. The FDA asks prescribers to become familiar with the product’s dosing recommendations and to recommend that patients use a properly marked measuring device.
Read the FDA Alert at: http://www.fda.gov:80/cder/drug/infopage/hydrocodone/default.htm (access checked 4/9/08).
The prescribing information PDF can be downloaded at: http://www.fda.gov/cder/foi/label/2008/019111s015lbl.pdf (access checked 4/9/08).
Duloxetine Hydrochloride (Cymbalta®) – FDA Reports Postmarketing Study Results
Three years after drug approval, the FDA analyzed medication error reports and adverse event data on duloxetine, a serotonin & norepinephrine reuptake inhibitor (SNRI). About half of product use was in patients aged 41-60 years and 17% of prescriptions were written for the relief of neuropathic pain, an indication approved in September 2004. Of the 3 million patients who took the drug, 170 individual cases of bleeding were reported. The majority of reports involved the gastrointestinal tract, but bleeding also occurred in vascular and other body systems. Additional adverse events included hyponatremia (low serum sodium level), urinary retention or hesitancy, and 177 cases of medication errors. The FDA has made recommendations for labeling changes regarding the risks/precautions as well as changes to packaging labels to reduce medication errors. Additional reports of loss of consciousness and the potential risk of liver toxicity had already been identified and cautioned in current labeling. Duloxetine was the first drug reviewed as part of the FDA’s new program to review the post-approval safety of new products.
Read the FDA Drug Safety Report at: http://www.fda.gov/cder/dsn/2008_winter/nme.htm (access checked 4/3/08).
The Cymbalta package insert can be downloaded at: http://www.fda.gov/cder/foi/label/2007/021427s015s017lbl.pdf (access checked 4/3/08).
Opana® ER (Oxymorphone Extended Release) – 3 New Strengths Approved
The FDA approved 3 new dosage strengths of Opana®ER – 7.5 mg, 15 mg, and 30 mg – and were reported to be available as of April 1, 2008. The new strengths will facilitate opioid conversion and titration for optimal pain relief. Opana ER was developed for the relief of moderate-to-severe pain for patients who need around-the-clock opioid treatment. It is currently available in 5 mg, 10 mg, 20 mg, and 40 mg strengths and is appropriate for opioid-naïve as well as opioid-tolerant patients.
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