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Pharma Industry / Biotech Industry News From Medical News Today
The Potential For Using Algae To Produce Human Therapeutic Proteins
Tue, 09 Mar 2010 05:00:00 -0800
Pharmaceutical companies could substantially reduce the expense of costly treatments for cancer and other diseases produced from mammalian or bacterial cells by growing these human therapeutic proteins in algae - rapidly growing aquatic plant cells that have recently gained attention for their ability to produce biofuels...
Computer Reminders For Physicians Less Effective Than Expected
Tue, 09 Mar 2010 03:00:00 -0800
Computer reminders to physicians regarding prescribing produce much smaller improvements than initially expected, found a study in CMAJ (Canadian Medical Association Journal). Computerized systems for entering orders and electronic medical records are the two most widely recommended improvements in health care...
Science World Charmed By Snake Venom
Tue, 09 Mar 2010 02:00:00 -0800
The King Cobra continues to weave its charm with researchers identifying a protein in its venom with the potential for new drug discovery and to advance understanding of disease mechanisms. The novel protein named haditoxin has been described in the prestigious Journal of Biological Chemistry (March 12, 2010)...
Nektar Announces Positive Phase 2 Clinical Data From First Stage Of NKTR-102 Study In Women With Platinum-Resistant Ovarian Cancer
Tue, 09 Mar 2010 01:00:00 -0800
Nektar Therapeutics (Nasdaq: NKTR) announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer...
NOVAVAX Completes Enrollment Of Pivotal H1N1 Influenza Vaccine Clinical Trial In Mexico
Tue, 09 Mar 2010 01:00:00 -0800
Novavax, Inc. (Nasdaq: NVAX) announced that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects...
Acologix Presents Data On Cartilage Regeneration By AC-100 At The 56th Annual Meeting Of The Orthopaedic Research Society
Tue, 09 Mar 2010 01:00:00 -0800
Acologix, Inc., a privately held biopharmaceutical company, announced the results of its latest preclinical study demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein, promotes cartilage regeneration in a large animal model. The data will be presented by Dr. David M...
Annals of Pharmacotherapy PAP Articles
Costs of Gastrointestinal Events After Outpatient Opioid Treatment for Non-Cancer Pain (April)
Kwong, W. J., Diels, J., Kavanagh, S. BACKGROUND: Gastrointestinal (GI) adverse effects are common with oral opioid treatment. OBJECTIVE: To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective. METHODS: Medical and pharmacy claims from the PharMetrics' Patient-Centric Database were used to identify opioid-naïve patients who received a new prescription for oxycodone- or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases-9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities. RESULTS: Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits (0.36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001). CONCLUSIONS: The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system.
Use of Daptomycin in a Pregnant Patient with Staphylococcus aureus Endocarditis (April)
Stroup, J. S, Wagner, J., Badzinski, T. OBJECTIVE: To report on 6 weeks of daptomycin treatment for tricuspid valve endocarditis caused by Staphylococcus aureus in a pregnant female in her second trimester. CASE SUMMARY: A 24-year-old, 14-week pregnant patient with no significant medical history, but with a history of intravenous drug abuse presented with tricuspid valve endocarditis caused by methicillin-sensitive S. aureus. After initial treatment with vancomycin, the patient continued to have fever and bacteremia and was initiated on daptomycin 6 mg/kg for 6 weeks of therapy. The treatment resulted in the resolution of the endocarditis, and no adverse sequelae were identified in the mother or baby. DISCUSSION: Infective endocarditis is a common infection encountered in the hospital setting and represents an increased cost burden to institutions due to prolonged lengths of treatment. Antimicrobial resistance, antimicrobial failure, inadequate attainment of effective drug concentrations, drug allergies, and adverse reactions may be factors that limit the use of commonly utilized antimicrobial agents. Therefore, newer therapies like daptomycin may need to be employed in these situations. Although daptomycin is pregnancy category B, limited case reports with neonatal outcomes are reported. CONCLUSIONS: This case provides further support for the safety of daptomycin in pregnancy with the dose of 6 mg/kg, the extended duration of therapy (6 weeks), and the primary exposure in the second trimester.
Symptomatic Hypoglycemia Associated with Trimethoprim/Sulfamethoxazole and Repaglinide in a Diabetic Patient (April)
Roustit, M., Blondel, E., Villier, C., Fonrose, X., Mallaret, M. P OBJECTIVE: To report a case of clinically significant hypoglycemia attributed to the concomitant use of trimethoprim/sulfamethoxazole (TMP/SMX) and repaglinide by a diabetic patient. CASE SUMMARY: A 76-year-old diabetic patient with impaired renal function and no history of hypoglycemia was receiving treatment with repaglinide 1 mg 3 times daily. Five days after TMP/SMX therapy was started for a urinary tract infection, the man developed symptomatic hypoglycemia. Repaglinide and TMP/SMX were stopped and intravenous D-glucose was administered to normalize glucose levels. Repaglinide, but not TMP/SMX, was reintroduced 5 days later and no other hypoglycemic episode occurred. Objective causality assessments revealed that the interaction was probable (World Health Organization-Uppsala Monitoring Centre) or possible (Horn Drug Interaction Probability Scale). DISCUSSION: This interaction between TMP/SMX and repaglinide was predictable according to available pharmacokinetic data in healthy subjects. Trimethoprim induced CYP2C8 inhibition, thus increasing the plasma concentration of repaglinide. This interaction is mentioned in the repaglinide product information. To our knowledge, however, no case of symptomatic hypoglycemia associated with a combination of repaglinide and trimethoprim has been described before. This discrepancy may be explained by the subtherapeutic dosage used in the pharmacokinetic study. Moreover, our patient had impaired renal function, which may have led to trimethoprim accumulation and potentiated its interaction with repaglinide. A direct lowering of blood glucose levels due to sulfamethoxazole, also potentiated by renal failure, could also be involved in triggering hypoglycemia. CONCLUSIONS: This interaction between TMP/SMX and repaglinide may have involved inhibition of CYP2C8 by trimethoprim. Clinicians should be aware that this association may lead to symptomatic hypoglycemia, particularly in patients with renal dysfunction.
New Combination Vaccines: DTaP-IPV (Kinrix) and DTaP-IPV/Hib (Pentacel) (March) (CE)
Johns, T. L, Hutter, G. E OBJECTIVE: To evaluate the clinical utility of diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine ([DTaP-IPV]; Kinrix) and diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine ([DTaP-IPV/Hib]; Pentacel) in the schedule for pediatric immunizations. DATA SOURCES: PubMed was searched (1966-April 2009) using the key words Kinrix and Pentacel. Subject headings included vaccines, combined; diphtheria-tetanus- pertussis vaccine; diphtheria-tetanus-acellular pertussis vaccines; poliovirus vaccine, inactivated; and Haemophilus influenzae type b polysaccharide vaccine-tetanus toxin conjugate. The search was limited to English-language publications involving humans. Product labeling was obtained from GlaxoSmithKline and Sanofi Pasteur. The Centers for Disease Control and Prevention (CDC) Web site was searched for relevant recommendations published June 2008-October 2009. STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 clinical trials evaluating immunogenicity and safety of DTaP-IPV and DTaP-IPV/Hib were reviewed. Published trials were supplemented with abstracts, review articles, manufacturer product labeling, and CDC recommendations. DATA SYNTHESIS: DTaP-IPV is immunogenic compared to its component vaccines, with no effect of concomitantly administered measles, mumps, and rubella vaccine. Although injection site pain has occurred more with the combination vaccine, its use would reduce by 1 the number of injections given when a child is 4-6 years old. DTaP-IPV/Hib is immunogenic and safe compared to separate vaccines. Immunogenicity to 7-valent pneumococcal conjugate vaccine and hepatitis B (HepB) vaccine is not affected by concomitant administration. DTaP-IPV/Hib decreases injections by up to 7 when given at 2, 4, 6, and 15-18 months of age. It fits into the schedule more easily than DTaP-HepB-IPV (Pediarix), the other DTaP-containing combination vaccine indicated for the primary infant series. CONCLUSIONS: DTaP-IPV and DTaP-IPV/Hib combination vaccines are immunogenic and safe when given to infants and children. They reduce the number of required injections. Combination vaccines are encouraged to promote timely vaccination and complete immunization schedules.
Hypertrophic Cranial Pachymeningitis Induced by Long-Term Administration of Nonsteroidal Antiinflammatory Drugs (April)
Zhou, Z., Li, Q., Zheng, J. OBJECTIVE: To report a case of hypertrophic cranial pachymeningitis (HCP) associated with the long-term administration of nonsteroidal antiinflammatory drugs (NSAIDs). CASE SUMMARY: A 23-year-old man presented with recurrent headaches as the primary clinical manifestation. After the administration of the NSAIDs indomethacin and aceclofenac for 2 years, he developed signs of progressive cranial polyneuropathies (eg, II, III, V, VI, and VII palsy) and damage to the brainstem. Cranial contrast-enhanced magnetic resonance imaging (MRI) revealed curvilinear subdural enhancement and significant tentorium cerebelli and falx cerebri enhancements. Since antituberculosis treatment combined with corticosteroid therapy and analgesia with celecoxib for 40 days had not achieved satisfactory results, NSAIDs were discontinued and a single oral dose of a corticosteroid was given. No headaches were reported at a 6-month follow-up appointment. In addition, his cranial polyneuropathy improved significantly. Reexamination by contrast-enhanced MRI scan demonstrated that tentorial enhancement and thickening of the falx cerebri were markedly alleviated. DISCUSSION: No additional causes of HCP were found during systematic investigation in this patient. In addition to headache, cranial polyneuropathy and thickened cerebral dura mater appeared after administration of NSAIDs for 2 years. The symptoms that appeared during the NSAID therapy were remarkably alleviated 5 months after medication discontinuation. Adverse drug reaction (ADR) assessment revealed that long-term administration of NSAIDs may be associated with the occurrence and development of HCP. CONCLUSIONS: Long-term administration of NSAIDs is a probable cause of HCP. Clinicians should be aware of this ADR and avoid prescribing NSAIDs for an extended period.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds
In This Issue
Wed, 17 Feb 2010 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 87, 245 (March 2010). doi:10.1038/clpt.2009.304
The Economics of Drug Development: A Grim Reality and a Role for Clinical Pharmacology
P HonigR Lalonde Wed, 17 Feb 2010 00:00:00 -0000
The Economics of Drug Development: A Grim Reality and a Role for Clinical Pharmacology Clinical Pharmacology & Therapeutics 87, 247 (March 2010). doi:10.1038/clpt.2009.298 Authors: P Honig & R Lalonde
Highlights
Wed, 17 Feb 2010 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 87, 252 (March 2010). doi:10.1038/clpt.2009.305 Author:
ASCPT News
Wed, 17 Feb 2010 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 87, 254 (March 2010). doi:10.1038/clpt.2009.300
Biosimilars: Evidential Standards for Health Technology Assessment
D A Hughes Wed, 17 Feb 2010 00:00:00 -0000
Biosimilars: Evidential Standards for Health Technology Assessment Clinical Pharmacology & Therapeutics 87, 257 (March 2010). doi:10.1038/clpt.2009.112 Author: D A Hughes
How Innovative Technology Is Moving Biologics Into the 21st Century
D K RobinsonN Sethuraman Wed, 17 Feb 2010 00:00:00 -0000
How Innovative Technology Is Moving Biologics Into the 21st Century Clinical Pharmacology & Therapeutics 87, 261 (March 2010). doi:10.1038/clpt.2009.294 Authors: D K Robinson & N Sethuraman
Subscribe to Pharmacology RSS feed 
The Potential For Using Algae To Produce Human Therapeutic Proteins
Tue, 09 Mar 2010 05:00:00 -0800
Pharmaceutical companies could substantially reduce the expense of costly treatments for cancer and other diseases produced from mammalian or bacterial cells by growing these human therapeutic proteins in algae - rapidly growing aquatic plant cells that have recently gained attention for their ability to produce biofuels...
Computer Reminders For Physicians Less Effective Than Expected
Tue, 09 Mar 2010 03:00:00 -0800
Computer reminders to physicians regarding prescribing produce much smaller improvements than initially expected, found a study in CMAJ (Canadian Medical Association Journal). Computerized systems for entering orders and electronic medical records are the two most widely recommended improvements in health care...
Science World Charmed By Snake Venom
Tue, 09 Mar 2010 02:00:00 -0800
The King Cobra continues to weave its charm with researchers identifying a protein in its venom with the potential for new drug discovery and to advance understanding of disease mechanisms. The novel protein named haditoxin has been described in the prestigious Journal of Biological Chemistry (March 12, 2010)...
Nektar Announces Positive Phase 2 Clinical Data From First Stage Of NKTR-102 Study In Women With Platinum-Resistant Ovarian Cancer
Tue, 09 Mar 2010 01:00:00 -0800
Nektar Therapeutics (Nasdaq: NKTR) announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer...
NOVAVAX Completes Enrollment Of Pivotal H1N1 Influenza Vaccine Clinical Trial In Mexico
Tue, 09 Mar 2010 01:00:00 -0800
Novavax, Inc. (Nasdaq: NVAX) announced that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects...
Acologix Presents Data On Cartilage Regeneration By AC-100 At The 56th Annual Meeting Of The Orthopaedic Research Society
Tue, 09 Mar 2010 01:00:00 -0800
Acologix, Inc., a privately held biopharmaceutical company, announced the results of its latest preclinical study demonstrating that AC-100, its therapeutic product candidate derived from an endogenous human protein, promotes cartilage regeneration in a large animal model. The data will be presented by Dr. David M...
Annals of Pharmacotherapy PAP Articles
Costs of Gastrointestinal Events After Outpatient Opioid Treatment for Non-Cancer Pain (April)
Kwong, W. J., Diels, J., Kavanagh, S. BACKGROUND: Gastrointestinal (GI) adverse effects are common with oral opioid treatment. OBJECTIVE: To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective. METHODS: Medical and pharmacy claims from the PharMetrics' Patient-Centric Database were used to identify opioid-naïve patients who received a new prescription for oxycodone- or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases-9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities. RESULTS: Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits (0.36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001). CONCLUSIONS: The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system.
Use of Daptomycin in a Pregnant Patient with Staphylococcus aureus Endocarditis (April)
Stroup, J. S, Wagner, J., Badzinski, T. OBJECTIVE: To report on 6 weeks of daptomycin treatment for tricuspid valve endocarditis caused by Staphylococcus aureus in a pregnant female in her second trimester. CASE SUMMARY: A 24-year-old, 14-week pregnant patient with no significant medical history, but with a history of intravenous drug abuse presented with tricuspid valve endocarditis caused by methicillin-sensitive S. aureus. After initial treatment with vancomycin, the patient continued to have fever and bacteremia and was initiated on daptomycin 6 mg/kg for 6 weeks of therapy. The treatment resulted in the resolution of the endocarditis, and no adverse sequelae were identified in the mother or baby. DISCUSSION: Infective endocarditis is a common infection encountered in the hospital setting and represents an increased cost burden to institutions due to prolonged lengths of treatment. Antimicrobial resistance, antimicrobial failure, inadequate attainment of effective drug concentrations, drug allergies, and adverse reactions may be factors that limit the use of commonly utilized antimicrobial agents. Therefore, newer therapies like daptomycin may need to be employed in these situations. Although daptomycin is pregnancy category B, limited case reports with neonatal outcomes are reported. CONCLUSIONS: This case provides further support for the safety of daptomycin in pregnancy with the dose of 6 mg/kg, the extended duration of therapy (6 weeks), and the primary exposure in the second trimester.
Symptomatic Hypoglycemia Associated with Trimethoprim/Sulfamethoxazole and Repaglinide in a Diabetic Patient (April)
Roustit, M., Blondel, E., Villier, C., Fonrose, X., Mallaret, M. P OBJECTIVE: To report a case of clinically significant hypoglycemia attributed to the concomitant use of trimethoprim/sulfamethoxazole (TMP/SMX) and repaglinide by a diabetic patient. CASE SUMMARY: A 76-year-old diabetic patient with impaired renal function and no history of hypoglycemia was receiving treatment with repaglinide 1 mg 3 times daily. Five days after TMP/SMX therapy was started for a urinary tract infection, the man developed symptomatic hypoglycemia. Repaglinide and TMP/SMX were stopped and intravenous D-glucose was administered to normalize glucose levels. Repaglinide, but not TMP/SMX, was reintroduced 5 days later and no other hypoglycemic episode occurred. Objective causality assessments revealed that the interaction was probable (World Health Organization-Uppsala Monitoring Centre) or possible (Horn Drug Interaction Probability Scale). DISCUSSION: This interaction between TMP/SMX and repaglinide was predictable according to available pharmacokinetic data in healthy subjects. Trimethoprim induced CYP2C8 inhibition, thus increasing the plasma concentration of repaglinide. This interaction is mentioned in the repaglinide product information. To our knowledge, however, no case of symptomatic hypoglycemia associated with a combination of repaglinide and trimethoprim has been described before. This discrepancy may be explained by the subtherapeutic dosage used in the pharmacokinetic study. Moreover, our patient had impaired renal function, which may have led to trimethoprim accumulation and potentiated its interaction with repaglinide. A direct lowering of blood glucose levels due to sulfamethoxazole, also potentiated by renal failure, could also be involved in triggering hypoglycemia. CONCLUSIONS: This interaction between TMP/SMX and repaglinide may have involved inhibition of CYP2C8 by trimethoprim. Clinicians should be aware that this association may lead to symptomatic hypoglycemia, particularly in patients with renal dysfunction.
New Combination Vaccines: DTaP-IPV (Kinrix) and DTaP-IPV/Hib (Pentacel) (March) (CE)
Johns, T. L, Hutter, G. E OBJECTIVE: To evaluate the clinical utility of diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine ([DTaP-IPV]; Kinrix) and diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine ([DTaP-IPV/Hib]; Pentacel) in the schedule for pediatric immunizations. DATA SOURCES: PubMed was searched (1966-April 2009) using the key words Kinrix and Pentacel. Subject headings included vaccines, combined; diphtheria-tetanus- pertussis vaccine; diphtheria-tetanus-acellular pertussis vaccines; poliovirus vaccine, inactivated; and Haemophilus influenzae type b polysaccharide vaccine-tetanus toxin conjugate. The search was limited to English-language publications involving humans. Product labeling was obtained from GlaxoSmithKline and Sanofi Pasteur. The Centers for Disease Control and Prevention (CDC) Web site was searched for relevant recommendations published June 2008-October 2009. STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 clinical trials evaluating immunogenicity and safety of DTaP-IPV and DTaP-IPV/Hib were reviewed. Published trials were supplemented with abstracts, review articles, manufacturer product labeling, and CDC recommendations. DATA SYNTHESIS: DTaP-IPV is immunogenic compared to its component vaccines, with no effect of concomitantly administered measles, mumps, and rubella vaccine. Although injection site pain has occurred more with the combination vaccine, its use would reduce by 1 the number of injections given when a child is 4-6 years old. DTaP-IPV/Hib is immunogenic and safe compared to separate vaccines. Immunogenicity to 7-valent pneumococcal conjugate vaccine and hepatitis B (HepB) vaccine is not affected by concomitant administration. DTaP-IPV/Hib decreases injections by up to 7 when given at 2, 4, 6, and 15-18 months of age. It fits into the schedule more easily than DTaP-HepB-IPV (Pediarix), the other DTaP-containing combination vaccine indicated for the primary infant series. CONCLUSIONS: DTaP-IPV and DTaP-IPV/Hib combination vaccines are immunogenic and safe when given to infants and children. They reduce the number of required injections. Combination vaccines are encouraged to promote timely vaccination and complete immunization schedules.
Hypertrophic Cranial Pachymeningitis Induced by Long-Term Administration of Nonsteroidal Antiinflammatory Drugs (April)
Zhou, Z., Li, Q., Zheng, J. OBJECTIVE: To report a case of hypertrophic cranial pachymeningitis (HCP) associated with the long-term administration of nonsteroidal antiinflammatory drugs (NSAIDs). CASE SUMMARY: A 23-year-old man presented with recurrent headaches as the primary clinical manifestation. After the administration of the NSAIDs indomethacin and aceclofenac for 2 years, he developed signs of progressive cranial polyneuropathies (eg, II, III, V, VI, and VII palsy) and damage to the brainstem. Cranial contrast-enhanced magnetic resonance imaging (MRI) revealed curvilinear subdural enhancement and significant tentorium cerebelli and falx cerebri enhancements. Since antituberculosis treatment combined with corticosteroid therapy and analgesia with celecoxib for 40 days had not achieved satisfactory results, NSAIDs were discontinued and a single oral dose of a corticosteroid was given. No headaches were reported at a 6-month follow-up appointment. In addition, his cranial polyneuropathy improved significantly. Reexamination by contrast-enhanced MRI scan demonstrated that tentorial enhancement and thickening of the falx cerebri were markedly alleviated. DISCUSSION: No additional causes of HCP were found during systematic investigation in this patient. In addition to headache, cranial polyneuropathy and thickened cerebral dura mater appeared after administration of NSAIDs for 2 years. The symptoms that appeared during the NSAID therapy were remarkably alleviated 5 months after medication discontinuation. Adverse drug reaction (ADR) assessment revealed that long-term administration of NSAIDs may be associated with the occurrence and development of HCP. CONCLUSIONS: Long-term administration of NSAIDs is a probable cause of HCP. Clinicians should be aware of this ADR and avoid prescribing NSAIDs for an extended period.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds
In This Issue
Wed, 17 Feb 2010 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 87, 245 (March 2010). doi:10.1038/clpt.2009.304
The Economics of Drug Development: A Grim Reality and a Role for Clinical Pharmacology
P HonigR Lalonde Wed, 17 Feb 2010 00:00:00 -0000
The Economics of Drug Development: A Grim Reality and a Role for Clinical Pharmacology Clinical Pharmacology & Therapeutics 87, 247 (March 2010). doi:10.1038/clpt.2009.298 Authors: P Honig & R Lalonde
Highlights
Wed, 17 Feb 2010 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 87, 252 (March 2010). doi:10.1038/clpt.2009.305 Author:
ASCPT News
Wed, 17 Feb 2010 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 87, 254 (March 2010). doi:10.1038/clpt.2009.300
Biosimilars: Evidential Standards for Health Technology Assessment
D A Hughes Wed, 17 Feb 2010 00:00:00 -0000
Biosimilars: Evidential Standards for Health Technology Assessment Clinical Pharmacology & Therapeutics 87, 257 (March 2010). doi:10.1038/clpt.2009.112 Author: D A Hughes
How Innovative Technology Is Moving Biologics Into the 21st Century
D K RobinsonN Sethuraman Wed, 17 Feb 2010 00:00:00 -0000
How Innovative Technology Is Moving Biologics Into the 21st Century Clinical Pharmacology & Therapeutics 87, 261 (March 2010). doi:10.1038/clpt.2009.294 Authors: D K Robinson & N Sethuraman
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DrugInfo. Searching the Web for Drug Information: A personal Website based on 30-years experience in pharmacology. Provides help to Web browsers in locating the most relevant drug information on the Web.
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Laboratory of Pulmonary Pharmacology: research in human vascular pharmacology, reactivity of bronchial and vascular tissues, role of the eicosanoids and the cholinergic system
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Pharmacology and Legal Drugs - About.com: Search the power of About's network of topics
Pharmacology-Info.com: Information about pharmacology, toxicology, getting a new drug to market, and FDA approval.
SMR's Case Histories of Drug Discovery: Drug symposium organized by Society for Medicines Research, drug discovery of infliximab, zanamivir, olanzapine, alosetron, leflunomide and celecoxib.
Social Audit - the Antidepressant Web: social audit
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The Ones That Stain Blue: Dr. Albert Hofmann
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TICTAC: The CD-ROM for drug identification of tablets & capsules
Toxicology-Info.com: Information on toxicology, drug interactions, toxicity and adverse reactions. Part of the ALtruis Biomedical Network.
University of Colorado Health Sciences Center - Department of Pharmacology: Department of Pharmacology and Graduate Program in Pharmacology at the University of Colorado Health Sciences Center at Denver and information about our pharmacology graduate program, curriculum, and research activities in the Pharmacology department. Research interests include: bioinformatics, m...
