May 23, 2011
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Resolved Drug Shortages: BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
Drug Shortages: Resolved Drug Shortages: Renacidin Irrigation NDC 00327-0011-05
FDA approves Incivek (telaprevir)for hepatitic C
Table of Pharmacogenomic Biomarkers in Drug Labels (updated)
New and Generic Drug Approvals
May 23, 2011
Incivek (telaprevir) Tablets, Vertex Pharmaceuticals, Inc., Approval
jueves, 26 de mayo de 2011
FDA MedWATCH
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results
AUDIENCE: Laboratory, Risk Manager
ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.
BACKGROUND: These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.
RECOMMENDATION: On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.
Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.
Healthcare professionals are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
AUDIENCE: Laboratory, Risk Manager
ISSUE: Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.
BACKGROUND: These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. Analyses are performed on a variety of fluids including blood, urine, and cerebrospinal fluid.
RECOMMENDATION: On April 5, 2011, the company sent its customers a Product Corrective Action letter including a customer response form. The company requested customers to follow the new maintenance instructions included in the letter.
Based on the available information at this time, it appears that the root cause may be a maintenance-related issue. However, the root cause has not been definitively determined and it is recommended that the laboratories maintain a level of vigilance to assess whether the change in maintenance routine resolves the issue.
Healthcare professionals are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
MedWATCH
Pentrexyl Forte Natural: Recall - Misleading Packaging
AUDIENCE: Consumer, Pharmacy
ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be confused with an antibiotic. Pentrexyl Forte Natural is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.
BACKGROUND: The product is packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.
RECOMMENDATION: Consumers who have purchased the product can return it to the place where it was purchased.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
AUDIENCE: Consumer, Pharmacy
ISSUE: Phoenix Import & Distribution LLC and FDA notified the public of a recall for Pentrexyl Forte Natural because the packaging is believed to be misleading, causing it to be confused with an antibiotic. Pentrexyl Forte Natural is a Dietary Supplement only and does not contain antibiotics. Use of the product by ill individuals could delay treatment for serious illnesses.
BACKGROUND: The product is packaged in a green and white box, containing 30 red and white capsules. The product was sold through retail stores in Texas.
RECOMMENDATION: Consumers who have purchased the product can return it to the place where it was purchased.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
EDQM News - May 2011
EDQM
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html
European Pharmacopoeia
Decisions taken at the 139th Session of the PhEur Commission: http://www.edqm.eu/en/News-and-General-Information-43.html
Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes (Deadline: 30 June 2011)
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html
Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Policy document revised - Suspension or withdrawal of a CEP : http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin & impact of the revised EU Note for Guidance on TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html
HealthCare - Classification of Medicines as Regards their Supply
Evidence-based classification reviews 2007-2010 available : http://www.edqm.eu/en/page_1241.php
Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
NEW: Pharmeuropa Bio & Scientific Notes 2011-1 (June 2011)
List of Contents now available. For more information on how to order : www.edqm.eu/store/
Instructions for Authors has been updated: http://www.edqm.eu/en/Pharmeuropa-Pharmeuropa-Bio-amp-Scientific-Notes-584.html
7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store
Technical Guides
Recommendations for the layout of monographs on substances of human and animal origin: http://www.edqm.eu/en/Technical-Guides-589.html
Employment
Vacancy Notice N° e105/2011: Fixed-term contract: Production/Distribution Operator (Grade C1/C2)
Reference Standards and Samples Division. Closing Date: 27 May 2011. More information: http://www.edqm.eu/en/Employment-1377.html
Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations : http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html
Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html
Other interesting events supported by the EDQM:
7-8 June 2011: 2011 PDA Europe Workshop on Advanced Therapy Medicinal Products in Collaboration with the Finnish Medicines Agency (Fimea)
Helsinki, Finland. More information: http://www.edqm.eu/en/Events-253.html
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html
World Blood Donor Day – Celebrating the gift of blood
World Blood Donor Day is celebrated on 14th June every year. The theme for this year is "More Blood. More Life". For more information on this Day and on events, visit: http://www.edqm.eu/en/World-Blood-Donor-Day-1381.html
European Pharmacopoeia
Decisions taken at the 139th Session of the PhEur Commission: http://www.edqm.eu/en/News-and-General-Information-43.html
Enquiry: Demonstration of Uniformity of Dosage Units using Large Sample Sizes (Deadline: 30 June 2011)
Proposal for a new general chapter in the European Pharmacopoeia. More information: http://www.edqm.eu/en/News-and-General-Information-43.html
Certification
Monthly Report of Activities (April 2011): http://www.edqm.eu/en/News-and-General-Information-164.html
Policy document revised - Suspension or withdrawal of a CEP : http://www.edqm.eu/en/News-and-General-Information-164.html
Note concerning CEPs for gelatin & impact of the revised EU Note for Guidance on TSE risk: http://www.edqm.eu/en/News-and-General-Information-164.html
HealthCare - Classification of Medicines as Regards their Supply
Evidence-based classification reviews 2007-2010 available : http://www.edqm.eu/en/page_1241.php
Publications
Blood Transfusion Guide
NEW EDITION: Guide to the preparation, use and quality assurance of blood components, 16th Edition (2010) now available to order. More information: http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
Organ Transplantation Guide
NEW EDITION: Guide to the safety and quality assurance for the transplantation of organs, tissues and cells, 4th Edition (2010) now available to order. More information:
http://www.edqm.eu/en/Blood_Transfusion_Organ_Transplantation_Guides-1131.html
NEW: Pharmeuropa Bio & Scientific Notes 2011-1 (June 2011)
List of Contents now available. For more information on how to order : www.edqm.eu/store/
Instructions for Authors has been updated: http://www.edqm.eu/en/Pharmeuropa-Pharmeuropa-Bio-amp-Scientific-Notes-584.html
7th Edition European Pharmacopoeia 2012
We are currently taking orders online for the 7th Edition 2012 (Supplement 7.3 to 7.5). For more information: www.edqm.eu/store
Technical Guides
Recommendations for the layout of monographs on substances of human and animal origin: http://www.edqm.eu/en/Technical-Guides-589.html
Employment
Vacancy Notice N° e105/2011: Fixed-term contract: Production/Distribution Operator (Grade C1/C2)
Reference Standards and Samples Division. Closing Date: 27 May 2011. More information: http://www.edqm.eu/en/Employment-1377.html
Events
Meet the EDQM at the 21st Regional Congress of the ISBT, 18-22 June 2011, Lisbon, Portugal: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Book today your ‘One-to-One Session’ with the EDQM Certification Division at CPhI China, 21-23 June 2011, Shanghai, China: http://www.edqm.eu/en/Fairs-Exhibitions-254.html
Places still available - 7th Edition European Pharmacopoeia Training Session, 11-12 July 2011, Strasbourg, France. Open for registrations : http://www.edqm.eu/en/PhEur-Training-Session-Strasbourg-France-256.html
Symposium on ‘Alternatives to Animal Testing’, 8-9 September 2011, Strasbourg, France. Open for registrations: http://www.edqm.eu/en/EDQM-Symposium-Alternatives-to-Animal-Testing-1374.html
Other interesting events supported by the EDQM:
7-8 June 2011: 2011 PDA Europe Workshop on Advanced Therapy Medicinal Products in Collaboration with the Finnish Medicines Agency (Fimea)
Helsinki, Finland. More information: http://www.edqm.eu/en/Events-253.html
APIB Event ‘Active Pharmaceutical Ingredients from Biotechnology: from research to industrial and regulatory issues’, 14-17 June 2011, Madrid, Spain.
More information: http://www.edqm.eu/en/APIB-2011-Madrid-Spain-14-17-June-2011-1405.html
What's New on the FDA Drugs Site
May 20, 2011
FDA approves new HIV treatment
FDA approves Sutent (sunitinib) for rare type of pancreatic cancer
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
New and Generic Drug Approvals
May 20, 2011
Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision
Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision
Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Kwikpen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Pen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision
Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision
Victoza (liraglutide [rDNA origin]) Subcutaneous Solution, Novo Nordisk, Inc., Labeling Revision
FDA approves new HIV treatment
FDA approves Sutent (sunitinib) for rare type of pancreatic cancer
FDA Drug Safety Podcast for Healthcare Professionals: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
New and Generic Drug Approvals
May 20, 2011
Aldactazide (spironolactone and hydrochlorothiazide) Tablets, Pfizer, Inc., Labeling Revision
Azor (amlodipine besylate and olmesartan medoxomil) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo, Labeling Revision
Capoten (captopril) Tablets, Par Pharmaceutical, Inc., Labeling Revision
Humalog (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Kwikpen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Humalog Pen (insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
Teveten HCT (eprosartan mesylate and hydrochlorothiazide) Tablets, Abbott Laboratories, Labeling Revision
Uniretic (moexipril hydrochloride and hydrochlorothiazide) Tablets, UCB, Inc., Labeling Revision
Victoza (liraglutide [rDNA origin]) Subcutaneous Solution, Novo Nordisk, Inc., Labeling Revision
lunes, 23 de mayo de 2011
SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition
AUDIENCE: Consumers, Pediatrics, Emergency medicine
ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND: FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.
The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_20_2011_1800&cpp[type]=S
ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue.
BACKGROUND: FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth.
The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.
RECOMMENDATION: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.
Read the MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=05_20_2011_1800&cpp[type]=S
What is new in FDA
May 19, 2011
Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals
May 19, 2011
Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision
Chantix: Quarterwatch Article
Drug Shortages: Current Drug Shortages: Acetylcysteine inhalation solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium molybdate injection
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Pentosan Polysulfate sodium 100mg capsules
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% (updated)
New and Generic Drug Approvals
May 19, 2011
Faslodex (fulvestrant) Injection, AstraZeneca Pharmaceuticals LP, Efficacy Supplement
Foradil (formoterol fumarate) Inhalation Powder, Novartis Pharmaceuticals Corp., Labeling Revision
Gemcitabine Injection, APP Pharmaceuticals, LLC, Approval
Genotropin (somatropin [rDNA origin]) Injection, Pfizer, Inc., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Nicorette (nicotine polacrilex) Gum, GlaxoSmithKline Consumer Healthcare, L.P., Labeling Revision
Potassium Chloride Extended-Release Capsules, Paddock Laboratories, Inc., Approval
Pravachol (pravastatin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Seroquel XR (quetiapine fumarate) Extended-Release Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
Vagifem (estradiol) Vaginal Tablets, Novo Nordisk Pharmaceuticals, Inc., Labeling Revision
Wellbutrin (bupropion hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, GlaxoSmithKline, Labeling Revision
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