 January-February 2009; Issue 19
News/Research Updates were 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; Edward Hesterlee, PharmD, FACA. Posting Date: February 23, 2009.
This edition Pain Treatment Topics News/Research Updates was supported by educational grants from COVIDIEN/Mallinckrodt, St. Louis, MO, and Purdue Pharma L.P., Stamford, CT. Any mention of product brand names is for informational purposes only and such brands are registered trademarks of their respective manufacturers. In some cases, additional product brands may be available. Also see Disclaimer below.
 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.
Lower Back Pain Often Has Origins Besides Spine
Orthopedic surgeons from the University of Minnesota evaluated 3 anatomical locations to determine the frequency that each was the primary pain generator in patients who complained of low back pain (LBP). There are several potential sources for LBP and pinpointing the source can be challenging in some patients. A consecutive case series cohort of new patients (n=200) were evaluated during a 10-month period to identify the frequency of spine, sacroiliac joint, or hip joint involvement as the primary source of pain.
Evaluations showed that 65% of patients had spine-only pathology while almost 18% had a combination of spine plus hip and/or sacroiliac joint pathology. Only 8% of patients had hip and/or sacroiliac joint pathology without spine pathology. A total of 10% had an unidentified pain source after diagnostic evaluation.
Clinical Concept: The authors concluded that up to 25% of patients who visit a spine surgeon’s practice for LBP may have significant pain contribution from the hip or sacroiliac joints. They recommend that practitioners stay vigilant for the possibility of non-spinal pain generators and appropriately consider alternative diagnoses.
Reference: Sembrano JN, Polly DW Jr. How often is low back pain not coming from the back? Spine. 2009(Jan);34(1):E27-E32.
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Routine Scans For Low Back Pain Don’t Improve Outcomes
New research suggests that routine use of lumbar imaging for low back pain may not be necessary. Investigators from the Oregon Health and Science University in Portland analyzed published clinical trials that compared the outcomes of patients who received immediate lumbar imaging (radiography, MRI, or CT scanning) with patients who received usual clinical care for low back pain without immediate imaging. Six controlled trials of more than 1,800 patients total met inclusion criteria and reported outcomes for pain or function and patient satisfaction with care received. No significant differences for pain or function were evident between the two groups in a short-term analysis (3 months or less) or longer-term follow-up (6-12 months). Additional outcome measures showed no significant differences between those patients receiving and not receiving imaging for their low back pain.
Practice Pointers: The authors stated that the results are “most applicable to acute or subacute low back pain assessed in primary-care settings” and suggested that the only limitation of the analysis was the small number of trials. They concluded that imaging in patients with low back pain, without signs of serious pathology, does not appear to improve patient outcomes. Practitioners were urged to refrain from routinely ordering costly MRIs and scans with radiation-exposure (X-rays and CT scans) for patients with acute or subacute low back pain who do not demonstrate the red-flags of a serious condition.
Reference: Chou R, Fu R, Carrino JA, et al. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009(Feb);373(9662):463-472.
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Chronic Lower Back Pain Increasing, Survey Shows
Data from a telephone survey of 5,357 households across North Carolina identified adults whose daily activities were limited because of chronic low back pain (LBP) of more than 3 months duration. These persons were subsequently interviewed regarding their health issues and healthcare-seeking that related to these conditions. The data from this survey, done in 2006, was compared to data from a previous study performed in 1992 (in 4,437 households).
Results showed that the prevalence of chronic LBP rose significantly from about 4% (1992) to just over 10% in 2006. The increase was evident for both men and women of all ages and in black and white races. Other factors, like symptom severity and general health status, were similar for both years. The number of people who saw a healthcare provider within the previous year rose from 73% (1992) to 84% in 2006.
Clinical Concepts: The authors stated that this was the first study in the United States to use consistent methodologies and definitions of chronic LBP for evaluating trends in prevalence over time. They suggested that possible causes of the increase in chronic LBP could be the rising rates of obesity and depression, a change in the type of work performed, as well as an increased awareness of this chronic condition; although, these variable were not measured. They further suggested that the increase in chronic LBP found in North Carolina may reflect a similar trend throughout the U.S.; however, such a trend cannot be certain from the data in this geographically limited study.
Source: Freburger JK, Holmes GM, Agans RP, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009(Feb 9);169(3):251-258.
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Antidepressants for Fibromyalgia Analyzed
Antidepressants are commonly prescribed for the symptomatic relief of fibromyalgia syndrome (FMS). German investigators examined data from 18 randomized controlled trials of antidepressants for FMS and performed a meta-analysis. Combined enrollment was 1,427 subjects and the average study duration was 8 weeks. Nine different medications were included: 2 monoamine oxidase inhibitor (MAOI) drugs, 2 serotonin-noradrenaline reuptake inhibitors (SNRI), 3 selective serotonin reuptake inhibitors (SSRI), and 2 tricyclic antidepressants (TCA).
Overall, there was strong evidence for an association of antidepressants with reductions in pain, fatigue, depressed mood, and sleep disturbances. There also was strong evidence for an association of antidepressants with improved health-related quality of life. TCAs in small doses (12.5–50 mg/day) had the largest effect sizes for reducing pain, fatigue, and sleep disturbances; the average benefit in TCA-treated subjects was greater than that experienced by about 90% of controls. Compared with TCAs, the effect sizes for MAOI, SSRI, and SNRI agents in reducing pain and other symptoms were smaller. Median rates of adverse effects were roughly similar in treated and control subjects.
Practice Pointer: All antidepressants appeared to provide moderate pain relief for FMS, but TCAs provided the greatest analgesic benefits, as well as reducing fatigue and sleep disturbances. However, the average study duration of 8 weeks may have been too brief for the full benefits of certain antidepressants to become evident. Currently, the SNRIs duloxetine (Cymbalta®) and Milnacipran (Savella®, see below) are the only antidepressants specifically FDA-approved for use in patients with FMS.
Source: Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with antidepressants: a meta-analysis. JAMA. 2009;301(2):198-209.
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Flexible-Dose Pregabalin Effective For Postherpetic Neuralgia
Postherpetic neuralgia (PHN) is commonly associated with allodynia — a condition in which pain results from a stimulus like light touch that would not normally provoke pain and can be very disabling. Pain experts at the Oregon Health and Science University in Portland randomized 269 patients with PHN to a 4-week regimen of flexibly-dosed pregabalin (Lyrica®, 150-600 mg/day), fixed-dose pregabalin (300 mg/day), or placebo.
Onset of pain relief was defined as the first day that a patient reported a reduction in pain compared with baseline. Clinically-meaningful pain relief was defined as a reduction of 30% or greater compared with pre-study pain scores. At baseline, pain and allodynia were closely correlated; 68% of patients experienced moderate to severe allodynia and almost 95% had brush-evoked allodynia.
Results showed that median onset times for any pain relief were 3.5 days in the flexible-dose group, 1.5 days in the fixed-dose patients, and more than 4 weeks for participants in the placebo group. Compared with placebo, a significant number of patients in both pregabalin groups had achieved up to 50% or more pain reduction at study’s end, and pregabalin also showed significantly greater efficacy in reducing allodynia. Pain reduction as measured on a 100 point scale was 26 mm with flexible-dose pregabalin, 21 mm with fixed-dose, and 12 mm with placebo. The fixed-dose treatment group experienced more adverse effects causing discontinuations.
Clinical Concepts: Patients in the flexible-dose group, allowing titration up to individualized effective dose levels, reached an average pregabalin dose of 396 mg/day. The authors concluded that flexible-dose therapy reduces treatment discontinuations and facilitates higher doses to allow for greater pain relief. Since allodynia severity is correlated with overall pain severity, an improvement in pain reduction also will reduce symptoms of allodynia.
Reference: Stacey BR, Barrett JA, Whalen E, et al. Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief. Journal of Pain. 2008(Nov);9(11):1006-1017.
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Migraines, Tension Headaches Respond to Acupuncture
Two new Cochrane systematic reviews have found that acupuncture therapy can benefit patients who suffer from tension headaches or migraine headache, providing an alternative treatment for their pain. In the first review [Linde et al. 2009], focusing on acupuncture for tension headaches, researchers evaluated 11 studies that investigated 2,317 participants. The studies compared participants who had undergone acupuncture therapy with those who had no treatment except pain relievers for acute headaches, or who had sham (“fake”) acupuncture (this mimicked “true” acupuncture but the needles were either inserted at incorrect points or did not penetrate the skin). Patients were followed for at least 8 weeks. Adding acupuncture to pain relievers resulted in significantly fewer headache days. In those studies comparing true versus sham acupuncture, improvements from both were noted and effects were only slightly better in those receiving true acupuncture.
A second Cochrane review [Melchart et al. 2009] examined acupuncture as migraine therapy and reviewed 22 trials including 4,419 total migraineurs with or without aura. In studies comparing acupuncture to no treatment or routine care (with painkillers), after 3 to 4 months those patients receiving acupuncture had fewer migraines. In trials comparing acupuncture with proven prophylactic drug treatment, patients receiving acupuncture tended to report more improvement and fewer side effects. The investigators concluded that there is consistent evidence that acupuncture provides benefits for the relief of migraine attacks; however, they also noted that placing the needles at the correct points did not seem particularly relevant. In other words, as with tension headaches, there appeared to be some benefit of pain relief regardless of the insertion points, which (the authors note) is contrary to what most acupuncturists believe.
Of further interest, a recently published meta-analysis [Madsen et al. 2009] examined the analgesic effects of acupuncture compared with placebo (sham) acupuncture and explored whether the type of placebo acupuncture made a difference. Researchers at the Nordic Cochrane Center in Denmark examined 13 trials (3,025 patients) involving a variety of pain conditions (including one trial examining tension headache and one for migraine). In all studies combined, only small differences were found between “true” acupuncture and placebo acupuncture, corresponding to a 4 mm (range 2 mm to 6 mm) benefit for “true” acupuncture on a 100 mm visual analog pain scale. Additionally, a moderate improvement was found with placebo acupuncture compared with no acupuncture, and the type of placebo acupuncture did not appear to make a difference.
[Comment: In the meta-analysis by Madsen et al. (2009) there were numerous methodological limitations, but the general impression from this and the other studies is that acupuncture does appear to have beneficial effects for tension headache and migraine. However, there may be some beneficial psychological influence of the acupuncture treatment process itself, since it seems that even either poorly performed or sham acupuncture can have pain-relieving benefits in some patients. More research would be helpful, even though there are difficulties in conducting adequately blinded and controlled trials of acupuncture to eliminate bias. — SBL.]
References:
Linde K, Allais G, Brinkhaus B, Manheimer E, Vickers A, White AR. Acupuncture for tension-type headache. Cochrane Database of Systematic Reviews 2009, Issue 1.
Melchart D, Linde K, Berman B, White A, Vickers A, Allais G, Brinkhaus B. Acupuncture for idiopathic headache. Cochrane Database of Systematic Reviews 2001, Issue 1. Updated and published in The Cochrane Database of Systematic Reviews 2009, Issue 1
Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomized clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009;338:a3115.
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Guidelines For Chronic Opioids in Noncancer Pain Published
A long-awaited clinical practice guideline from the American Pain Society and the American Academy of Pain Medicine provides 25 recommendations on the safe and effective chronic (long-term) use of opioids for carefully selected patients with chronic non-cancer pain (CNCP). The recommendations provide guidance on patient selection and risk stratification; informed consent and opioid management plans; initiation and titration of chronic opioid therapy; use of methadone; monitoring of patients on chronic opioid therapy; dose escalation; high-dose opioid therapy; opioid rotation; indications for discontinuation of therapy; prevention and management of opioid-related adverse effects; driving and work safety; identifying a medical home for patients and when to obtain consultation; management of breakthrough pain; and chronic opioid therapy in pregnancy.
[Comment: The guidelines-development panel members were hindered by an overall poor quality of evidence and they identified numerous research gaps. In fact, the panel did not rate any of its 25 recommendations as supported by high quality evidence, and only 4 recommendations were viewed as supported by even moderate quality evidence. Furthermore, although panel members recognized that, theoretically, opioids have no maximum or ceiling dose, they concurred that a reasonable definition for high-dose opioid therapy is >200 mg/day of oral morphine (or equivalent). This was based on a low level of evidence and the panel acknowledged that there actually is no standardized definition for what constitutes a ‘‘high’’ dose.
The panel conceded that, at present, clinical decisions regarding the use of opioids for chronic noncancer pain are based on weak evidence, which seems to suggest that the promulgation of these guidelines may be premature. A most important concern is that very little research supports whether or not the recommendations will favorably impact clinical outcomes. For example, the panel notes that several screening instruments exist for predicting the potential for prescription opioid misuse or abuse; however, clinical evidence for the external validity of these tools and their benefits for patient care are still lacking. — SBL.]
Source: Chou R, Fanciullo GJ, Fine PG, et al. Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. J Pain. 2009(Feb);10(2):113-230.
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Briefly Noted...
> Study Challenges High Prevalence of Opioid-Tolerance
The number of Americans taking maximal doses of opioid painkillers may be much smaller than previously estimated, according to a report released at the 2009 annual American Academy of Pain Medicine meeting. From 2.2 to 2.6 million people in the U.S. are taking opioids at doses equivalent to 60 mg/day of morphine for more than 90 consecutive days — a chronic dosage level at which patients are considered opioid-tolerant and ineligible for further dose escalations to control breakthrough pain, according to the report commissioned by Cephalon.
For the report, Arvind Narayana, MD, and colleagues obtained insurance claims and prescription data from a large, private insurance database covering 54.7 million adults, of whom 14.3 million had prescriptions for opioids at the time data were collected. The largest number, 9 million, were taking hydrocodone, followed by oxycodone, propoxyphene, tramadol, and codeine. Extrapolated to the entire U.S. population, the researchers estimated that about 44 to 51 million people had received opioid prescriptions, 5.4 to 6.2 million were taking these agents daily, and from 2.2 to 2.6 million could be regarded as opioid tolerant. Importantly, Narayana said that these data contradict testimony at an FDA advisory committee meeting indicating that a much larger number, as many as 13 to 18 million Americans, could be considered as opioid-tolerant.
[Note: Available information regarding this report does not specify the exact period of data collection or how the authors determined that 60 mg/day of morphine or equivalent taken for 90-days or longer denotes opioid tolerance. — SBL.]
Source: Narayana A, et al. A healthcare claims database analysis to estimate the prevalence of chronic opioid use in adult patients in the United States. Presentation at the American Academy of Pain Medicine Annual Meeting, February 2, 2009, Hawaii; abstract 278.
> Update on Nonmedical Use of Rx Opioid Analgesics
According to a government survey published in February 2009, the nonmedical use of prescription pain medications in the United States did not change significantly between 2002 and 2007. Data from the most recent U.S. National Survey on Drug Use and Health (NSDUH) from the Substance Abuse and Mental Health Services Administration (SAMHSA) showed that approximately 5.2 million Americans aged 12 years and older used prescription pain relievers for nonmedical purposes in the 2007 survey. While this rate for “past month” nonmedical use does not differ significantly from the 2002 data, there are several trend changes/updates in certain age groups:
- Youth (ages 12-17) nonmedical use of prescription pain relievers declined from 3.2% in 2002 to 2.7% in 2007.
- Young adult nonmedical use (ages 18-25) increased from 4.1% to 4.6%.
- Adult use (ages 26 and older) increased from 1.3% to 1.6%.
[Comment: In this survey, “nonmedical” use was defined as the use of Rx analgesics not prescribed for the respondent by a physician, or used only for the experience or feeling they caused. Therefore, the data may be distorted by also including the unauthorized use (misuse) of prescription analgesics by persons who obtained such drugs from others (eg, friend, relative) for essentially legitimate medical purposes (ie, pain relief). Such a distinction does make a difference in defining the true scope of the problem and for suggesting remedial actions. — SBL.]
Reference: SAMHSA/OAS. (February 5, 2009). The NSDUH Report: Trends in nonmedical use of prescription pain relievers: 2002 to 2007. (February 5, 2009). The NSDUH Report. Rockville, MD. Available at: http://oas.samhsa.gov/2k9/painRelievers/nonmedicalTrends.pdf (access checked 2/09/2009).
> FDA Requiring Drug Makers to Have Opioid Safety Plans
The U.S. Food and Drug Administration has announced it will require generic and brand-name opioid analgesic manufacturers to establish Risk Evaluation and Mitigation Strategies (REMS). The makers of products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have been invited to a meeting with the FDA in early March 2009 to discuss REMS development. Future meetings will include other federal agencies, non-governmental institutions, healthcare professionals, patient advocates, and others. Via REMS, the nature of which is still undefined, the FDA hopes to curb deaths and reduce opioid misuse to ensure that the benefits of opioid drugs continue to outweigh their risks.
> Chronic Pancreatitis Pain Relieved by Antioxidants
Researchers in New Delhi, India, explored the use of antioxidants to reduce painful symptoms of chronic pancreatitis (CP) that have been linked pathophysiologically to oxidative stress. In a placebo-controlled, double-blind study at a tertiary-care academic center, 127 consecutive patients with CP were randomized to receive daily doses of antioxidants (600 mcg organic selenium, 0.54 g ascorbic acid, 9000 IU beta-carotene, 270 IU alpha-tocopherol, and 2 g methionine) or placebo for a 6-month period.
At study’s end, the number of painful days per month in the antioxidant group decreased by more than twice that of the placebo group (7.4 +/- 6.8 versus 3.2 +/- 4.0, respectively; p < 0.001). Thirty-two percent of antioxidant-group participants became pain free, compared with 13% of placebo participants (p = 0.009). Additionally, analgesic consumption was reduced to less than half that of the placebo group (p = 0.001). Laboratory testing showed significant reductions in oxidative stress and increases in antioxidant status for the patients in the antioxidant group compared with placebo.
Clinical Concepts: The authors concluded that antioxidant supplementation was effective in relieving pain and lowering oxidative stress levels in this population of patients (mean age 30.5 [range 20 to 41], 68% were male, 35 had alcoholic CP and 92 were diagnosed with idiopathic CP). No adverse reactions were reported, but the authors note that this study does not identify the optimal length of supplementation or the long-term duration of therapeutic effects.
References: Bhardwaj P, Garg PK, Maulik SK, et al. A randomized controlled trial of antioxidant supplementation for pain relief in patients with chronic pancreatitis. Gastroenterology. 2009(Jan);136(1):149-159.
> Fibromyalgia Impairs Memory; Do Opioids Help?
According to a study by Bruce Dick and colleagues at the University of Alberta, Canada, persons with fibromyalgia may have disruption in their memory because of the pain. Researchers compared 30 women with fibromyalgia with 30 healthy women, all of whom performed a series of tasks to test memory and multitasking.
In this small study, fibromyalgia sufferers had impaired working memory, which became worse as tasks became more difficult mentally, and was disturbed further by pain related to fibromyalgia. Even taking into account other factors that can cause cognitive disruption, including sleep problems and depression, fibromyalgia-related pain negatively affected working memory. These findings, the researchers believe, help explain what patients call "fibro fog."
The investigators made an interesting and surprising discovery: a subgroup of patients that was taking opioid analgesics had much better memory function. In a news interview, Dick commented that, while the use of opioid drugs is controversial in these patients, opioids do seem to help them be more functional; however, the improvements in memory were not statistically significant, so further research in needed to explore this effect.
Reference: Dick BD, Verrier MJ, Harker KT, Rashiq S. Disruption of cognitive function in fibromyalgia syndrome. Pain. 2008;139:610-616.
> Duloxetine for Osteoarthritis Knee Pain Studied
In an industry-sponsored study, duloxetine (Cymbalta®) 60-120 mg, taken once daily, reduced pain severity significantly compared with placebo in patients with osteoarthritis pain of the knee. Data from the 13-week randomized, double-blind, placebo-controlled clinical trial were presented at the annual meeting of the American Academy of Pain Medicine (AAPM) in Honolulu, Hawaii.
Duloxetine-treated patients (n=128) showed greater reductions from baseline on 24-hour average pain scores on the Brief Pain Inventory (BPI), the primary endpoint, compared with placebo-treated patients (n=128). Furthermore, 65% of duloxetine-treated patients experienced a clinically significant (at least 30%) improvement in pain, compared with 44% of placebo-treated patients. The duloxetine-treated patients also showed improved physical function, compared with placebo-treated patients, as measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC). However, patients on duloxetine did not show statistically significant improvements on the WOMAC pain and stiffness subscales compared with placebo. A total of 31 patients in the study discontinued due to adverse events; 7 in the placebo-treated group and 24 in the duloxetine-treated group.
Reference: Chappell A, et al. Duloxetine 60 to 120 mg once daily versus placebo in the treatment of patients with osteoarthritis knee pain. Poster presented at the American Academy of Pain Medicine Annual Meeting, January 29, 2009, Hawaii.
Also see earlier study: Sullivan MD, Bentley S, Fan MY, Gardner G. A single-blind, placebo run-in study of duloxetine for activity-limiting osteoarthritis pain. J Pain. 2009;10(2):208-213.
> Diclofenac Epolamine Patch Relieves Osteoarthritis Pain
Researchers attending the American Academy of Pain Medicine 25th Annual Meeting in January 2009 reported results of a double-blind study of a diclofenac epolamine 1.3% topical patch (Flector® patch) prescribed for the pain of knee osteoarthritis (OA). Patients with knee OA (n=155) and a pain score >40 (on a 0-to-100 scale) were randomized to transdermal diclofenac epolamine 1.3% or a placebo patch twice daily for 15 days. Acetaminophen was allowed on days 4 to 15 as rescue medicine.
Patients on the diclofenac epolamine patch reported significant improvement in pain scores within 1 hour of treatment as compared with baseline (p = 0.013), a difference that was maintained through the 15 days of therapy. These patients reported a reduction in median pain scores of 30% by day 2 and 50% by day 7. Participants using the placebo patch achieved a 30% reduction by day 6. At study’s end, pain score reductions averaged 70% for the diclofenac-patch group compared with 38% for placebo (p < 0.0001). There were no major adverse effects and patch tolerability for both groups was similar.
Clinical Concepts: The researchers concluded that the use of “topical NSAIDs such as diclofenac epolamine in the treatment of OA have low systemic absorption and provide analgesia, potentially avoiding the risks associated with oral NSAIDs.” The diclofenac epolamine 1.3% patch may offer a localized treatment alternative for patients who cannot tolerate the higher systemic drug levels of oral NSAIDs.
[Comment: The diclofenac epolamine patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. As with other NSAIDs, labeling for this product indicates that it may incur increased cardiovascular risks and may cause an increased risk of gastrointestinal adverse events. — SBL.]
References: Rovati S, et al. Timing of effect of diclofenac epolamine topical patch 1.3% (Flector Patch) in the treatment of pain due to osteoarthritis of the knee. American Academy of Pain Medicine 25th Annual Meeting. January 27-31, 2009. Honolulu, Hawaii. Abstract 237. Also reported by Doctor’s Guide, February 2, 2009.
> Survey on Complementary Medicine Use For Pain
Survey results from the 2007 U.S. National Health Interview Survey (NHIS) — released in December 2008 and compiled by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Center for Health Statistics — show a more than 2% increase in the use of complementary and alternative medicine (CAM) for a variety of health conditions, including pain. The telephone survey, which included 23,000 adults and 9,500 children, found that 38% of adults and 12% of children used CAM in 2007.
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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. All brand names are registered trademarks of their respective manufacturers.
Generic Analgesic Recall – ETHEX Corporation Broadens Earlier Recall
In an expanded voluntary recall, ETHEX Corp. issued a January 2009 press release to recall over 60 generic drug products that may not have been manufactured according to current Good Manufacturing Practices. The company has published a list of products (including lot numbers) at the wholesale and retail levels (see link below). Analgesic drugs include certain lots of Codeine Phosphate/Guaifenesin tablets, Hydrocodone Bitartrate & Acetaminophen liquid, Hydrocodone Bitartrate/Guaifenesin liquid, several Morphine Sulfate oral products, Oxycodone HCl IR tablets, and Hydromorphone HCl tablets.
Milnacipran HCl (Savella®) – FDA-Approved for Fibromyalgia
Forest Laboratories and Cypress Bioscience, owners of the North American rights to milnacipran, announced a January 2009 FDA approval of the drug, a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI). The approval was based on 2 phase III placebo-controlled trials of more than 2,000 patients diagnosed with fibromyalgia. Study results showed that a significant improvement in composite results of pain, patient global assessment, and physical function were reported by patients on milnacipran doses of 100 mg/day and 200 mg/day. Common adverse reactions were nausea, constipation, hot flush, vomiting, increased heart rate, and hypertension. The makers of Savella expect the drug to be available by March 2009.
Tocilizumab (RoActemra™) – European Commission Approval for RA
Roche Pharmaceuticals Division announced a January 2009 approval of RoActemra — the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody — for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The drug’s approval was based on 5 clinical studies that enrolled more than 4,000 patients in 41 countries and has shown effectiveness in relieving inflammation of the joints, pain, and certain systemic effects of RA. It is intended for adult patients who have not achieved therapeutic results with disease modifying anti-rheumatic drugs or tumor necrosis factor antagonists and can be administered as monotherapy or in combination with methotrexate. At present, Roche is working with the FDA to complete approval requirements for tocilizumab, called Actemra in the United States.
Oral Oxycodone/Naloxone Combination (Targin®) –Approved Outside U.S.
Mundipharma announced in January 2009 that 13 countries have approved their oral oxycodone and prolonged-release naloxone (opioid receptor antagonist) combination tablet. The new product, Targin, is the first drug designed to control severe chronic pain (oxycodone) while preventing the onset of opioid-induced constipation (naloxone) through the blocking of opioid receptors found in the gut. The drug, which has not yet received United States FDA approval, is scheduled for a series of European launches in Austria, Belgium, Cyprus, Denmark, Finland, Germany, Iceland, Ireland, Luxembourg, Netherlands, Norway, Sweden, and the United Kingdom.
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