Elizabeth Mechcatie

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

The approval of the quadrivalent meningococcal conjugate vaccine manufactured by Novartis has been expanded to include children aged 2-10 years, but does not yet include infants, the company announced on Jan. 31.

The Food and Drug Administration approved the use of the vaccine for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in children aged 2-10 years of age, according to a statement issued by Novartis. The company markets the vaccine (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine) as Menveo. It was approved in 2010 for use in adolescents and adults aged 11-55 years.

Novartis application for approval included children down to age 2 months. But the statement said that the FDA had not included this age group in the approval because of concerns raised that the company believes are of a "procedural nature," and that the company plans to resubmit the application for approval with more clinical data on children 2 months to 2 years within a few months.

Approval for the children aged 2-10 years was based on data in a phase III study of 5,297 children in that age group comparing the safety and immunogenicity against the four serogroups contained in the vaccine with those in the other meningococcal vaccine licensed in the United States, according to Novartis. The statement said that the company has agreed to conduct postmarketing studies.

The other meningococcal conjugate vaccine approved in the United States is Menactra, manufactured by Sanofi Pasteur, which is also approved for immunizing people aged 2-55 years against invasive meningococcal disease caused by the four serogroups contained in the vaccine, the same included in Menveo.

In the European Union, where Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate Vaccine, Novartis plans to submit data to support the use of the vaccine in children aged 0-10 years in the first half of 2011, according to the statement. In Canada, the application for use in children 2-10 years has been submitted.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.

The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.

The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.

The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.

Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.

The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.

The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.

The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.

Female Iraq and Afghanistan veterans were more likely to be diagnosed with depression than their male counterparts, who were more likely to be diagnosed with posttraumatic stress disorder, a retrospective study of U.S. veterans has shown.

These were among the significant gender differences between the male and female veterans identified in the study, which looked at sociodemographic and mental health characteristics among 329,049 Iraq and Afghanistan war veterans who went to a Veterans Affairs health care facility at least once between April 2002 and March 2008, the first time they had used the facilities since the start of the two wars (Am. J. Public Health 2010;100:2450-6).

"Gender differences are important to consider as the VA and the Department of Defense continue to expand and strengthen programs to evaluate and provide health care for a new generation of returning veterans," wrote the authors of the study, Shira Maguen, Ph.D., and her associates at the San Francisco VA Medical Center.

Of the total population studied, 12% were female and 53% were active duty, 28% of the women and 33% of the men had had multiple deployments, and 54% of the women and 69% of the men were white. Most (65% of the women and 63% of the men) were in the Army. Diagnoses were made by trained professionals and were based on DSM-IV criteria. At VA facilities, all veterans are screened for mental health disorders.

Depression diagnoses were significantly more common among the female veterans than among the males (23% vs. 17%). The rate of eating disorders also was higher among the female veterans (0.6% vs. 0.1%), as was the rate of anxiety disorders (12% vs. 10%), differences that were statistically but not clinically significant, the authors said.

Among the male veterans, diagnoses of posttraumatic stress disorder (PTSD) were significantly more common than among the female veterans (22% vs. 17%), as were substance use diagnoses (3% vs. 2%).

The authors identified significant interactions between gender and other variables, including age, marital status, branch and rank, and being diagnosed with PTSD and with depression.

Among both female and male veterans, a significant correlation was found between being diagnosed with PTSD and being divorced, separated, or widowed, compared with being married; being an Army vet, versus being a Navy or Air Force veteran; being in active duty service, compared with being in the Reserves; and having served multiple deployments, as opposed to one deployment. Women who were older than aged 30 years were at a significantly greater risk of being diagnosed with PTSD than were men, "for whom older age seemed to be a protective factor," the authors noted.

In addition, women were significantly more likely to be diagnosed with PTSD if they had never been married, were in the Reserves or National Guard, were in the Navy or Air Force, or were an officer.

A diagnosis of depression was significantly more likely among white female and male veterans; and among those who were divorced, separated, or widowed; as well as among those who had served in the Army, had been in active duty, or were enlisted. Women who were older than aged 30 years also were significantly more likely to be diagnosed with depression, as were women older than 40.

Being black was a protective factor for a depression diagnosis in both men and women, the authors said, referring to evidence suggesting that ethnic and racial minorities have stronger social support networks than whites and return home to more supportive communities than whites. This finding points to the "importance of determining level of social support in relationships, among families, and in veterans’ communities and of focusing on community reintegration for recently returned veterans," they wrote.

The authors described age as "the most pronounced gender difference" that was correlated with PTSD and depression, with older women at a greater risk for being diagnosed with PTSD and depression than younger women. However, younger men were at a greater risk of being diagnosed with PTSD than older men, which the authors speculated could be related to difficulties older women with more established family and community ties have when deploying and reintegrating into those communities when they return home.

These results "contribute to a better understanding of the characteristics of women seeking VA health care as well as how these characteristics may differentially be associated with mental health outcomes," they noted.

The results cannot be generalized to all military personnel from the two wars, or veterans of other wars, which were among the study’s limitations, they said. Previous studies of gender differences in mental health outcomes among Iraq and Afghanistan war veterans have had mixed results.

No disclosures were listed for the authors. The study was funded by a Department of Defense Concept Award Grant and a VA Health Services Research and Development Career Development Award.

Female Iraq and Afghanistan veterans were more likely to be diagnosed with depression than their male counterparts, who were more likely to be diagnosed with posttraumatic stress disorder, a retrospective study of U.S. veterans has shown.

These were among the significant gender differences between the male and female veterans identified in the study, which looked at sociodemographic and mental health characteristics among 329,049 Iraq and Afghanistan war veterans who went to a Veterans Affairs health care facility at least once between April 2002 and March 2008, the first time they had used the facilities since the start of the two wars (Am. J. Public Health 2010;100:2450-6).

"Gender differences are important to consider as the VA and the Department of Defense continue to expand and strengthen programs to evaluate and provide health care for a new generation of returning veterans," wrote the authors of the study, Shira Maguen, Ph.D., and her associates at the San Francisco VA Medical Center.

Of the total population studied, 12% were female and 53% were active duty, 28% of the women and 33% of the men had had multiple deployments, and 54% of the women and 69% of the men were white. Most (65% of the women and 63% of the men) were in the Army. Diagnoses were made by trained professionals and were based on DSM-IV criteria. At VA facilities, all veterans are screened for mental health disorders.

Depression diagnoses were significantly more common among the female veterans than among the males (23% vs. 17%). The rate of eating disorders also was higher among the female veterans (0.6% vs. 0.1%), as was the rate of anxiety disorders (12% vs. 10%), differences that were statistically but not clinically significant, the authors said.

Among the male veterans, diagnoses of posttraumatic stress disorder (PTSD) were significantly more common than among the female veterans (22% vs. 17%), as were substance use diagnoses (3% vs. 2%).

The authors identified significant interactions between gender and other variables, including age, marital status, branch and rank, and being diagnosed with PTSD and with depression.

Among both female and male veterans, a significant correlation was found between being diagnosed with PTSD and being divorced, separated, or widowed, compared with being married; being an Army vet, versus being a Navy or Air Force veteran; being in active duty service, compared with being in the Reserves; and having served multiple deployments, as opposed to one deployment. Women who were older than aged 30 years were at a significantly greater risk of being diagnosed with PTSD than were men, "for whom older age seemed to be a protective factor," the authors noted.

In addition, women were significantly more likely to be diagnosed with PTSD if they had never been married, were in the Reserves or National Guard, were in the Navy or Air Force, or were an officer.

A diagnosis of depression was significantly more likely among white female and male veterans; and among those who were divorced, separated, or widowed; as well as among those who had served in the Army, had been in active duty, or were enlisted. Women who were older than aged 30 years also were significantly more likely to be diagnosed with depression, as were women older than 40.

Being black was a protective factor for a depression diagnosis in both men and women, the authors said, referring to evidence suggesting that ethnic and racial minorities have stronger social support networks than whites and return home to more supportive communities than whites. This finding points to the "importance of determining level of social support in relationships, among families, and in veterans’ communities and of focusing on community reintegration for recently returned veterans," they wrote.

The authors described age as "the most pronounced gender difference" that was correlated with PTSD and depression, with older women at a greater risk for being diagnosed with PTSD and depression than younger women. However, younger men were at a greater risk of being diagnosed with PTSD than older men, which the authors speculated could be related to difficulties older women with more established family and community ties have when deploying and reintegrating into those communities when they return home.

These results "contribute to a better understanding of the characteristics of women seeking VA health care as well as how these characteristics may differentially be associated with mental health outcomes," they noted.

The results cannot be generalized to all military personnel from the two wars, or veterans of other wars, which were among the study’s limitations, they said. Previous studies of gender differences in mental health outcomes among Iraq and Afghanistan war veterans have had mixed results.

No disclosures were listed for the authors. The study was funded by a Department of Defense Concept Award Grant and a VA Health Services Research and Development Career Development Award.

Female Iraq and Afghanistan veterans were more likely to be diagnosed with depression than their male counterparts, who were more likely to be diagnosed with posttraumatic stress disorder, a retrospective study of U.S. veterans has shown.

These were among the significant gender differences between the male and female veterans identified in the study, which looked at sociodemographic and mental health characteristics among 329,049 Iraq and Afghanistan war veterans who went to a Veterans Affairs health care facility at least once between April 2002 and March 2008, the first time they had used the facilities since the start of the two wars (Am. J. Public Health 2010;100:2450-6).

"Gender differences are important to consider as the VA and the Department of Defense continue to expand and strengthen programs to evaluate and provide health care for a new generation of returning veterans," wrote the authors of the study, Shira Maguen, Ph.D., and her associates at the San Francisco VA Medical Center.

Of the total population studied, 12% were female and 53% were active duty, 28% of the women and 33% of the men had had multiple deployments, and 54% of the women and 69% of the men were white. Most (65% of the women and 63% of the men) were in the Army. Diagnoses were made by trained professionals and were based on DSM-IV criteria. At VA facilities, all veterans are screened for mental health disorders.

Depression diagnoses were significantly more common among the female veterans than among the males (23% vs. 17%). The rate of eating disorders also was higher among the female veterans (0.6% vs. 0.1%), as was the rate of anxiety disorders (12% vs. 10%), differences that were statistically but not clinically significant, the authors said.

Among the male veterans, diagnoses of posttraumatic stress disorder (PTSD) were significantly more common than among the female veterans (22% vs. 17%), as were substance use diagnoses (3% vs. 2%).

The authors identified significant interactions between gender and other variables, including age, marital status, branch and rank, and being diagnosed with PTSD and with depression.

Among both female and male veterans, a significant correlation was found between being diagnosed with PTSD and being divorced, separated, or widowed, compared with being married; being an Army vet, versus being a Navy or Air Force veteran; being in active duty service, compared with being in the Reserves; and having served multiple deployments, as opposed to one deployment. Women who were older than aged 30 years were at a significantly greater risk of being diagnosed with PTSD than were men, "for whom older age seemed to be a protective factor," the authors noted.

In addition, women were significantly more likely to be diagnosed with PTSD if they had never been married, were in the Reserves or National Guard, were in the Navy or Air Force, or were an officer.

A diagnosis of depression was significantly more likely among white female and male veterans; and among those who were divorced, separated, or widowed; as well as among those who had served in the Army, had been in active duty, or were enlisted. Women who were older than aged 30 years also were significantly more likely to be diagnosed with depression, as were women older than 40.

Being black was a protective factor for a depression diagnosis in both men and women, the authors said, referring to evidence suggesting that ethnic and racial minorities have stronger social support networks than whites and return home to more supportive communities than whites. This finding points to the "importance of determining level of social support in relationships, among families, and in veterans’ communities and of focusing on community reintegration for recently returned veterans," they wrote.

The authors described age as "the most pronounced gender difference" that was correlated with PTSD and depression, with older women at a greater risk for being diagnosed with PTSD and depression than younger women. However, younger men were at a greater risk of being diagnosed with PTSD than older men, which the authors speculated could be related to difficulties older women with more established family and community ties have when deploying and reintegrating into those communities when they return home.

These results "contribute to a better understanding of the characteristics of women seeking VA health care as well as how these characteristics may differentially be associated with mental health outcomes," they noted.

The results cannot be generalized to all military personnel from the two wars, or veterans of other wars, which were among the study’s limitations, they said. Previous studies of gender differences in mental health outcomes among Iraq and Afghanistan war veterans have had mixed results.

No disclosures were listed for the authors. The study was funded by a Department of Defense Concept Award Grant and a VA Health Services Research and Development Career Development Award.

The Food and Drug Administration has expanded its approval of tocilizumab to include labeling claims regarding the biologic drug’s effects on joint damage, physical function, and major clinical response in people with rheumatoid arthritis, according to the manufacturer, Genentech Inc.

On Jan. 5, Genentech announced that the FDA had approved the addition of the following information to the tocilizumab prescribing label, based on data from the LITHE (Tocilizumab Safety and the Prevention of Structural Joint Damage) study: inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adults with moderately to severely active RA treated with tocilizumab and methotrexate.

The supplemental approval comes a year after the FDA approved tocilizumab, an interleukin-6 receptor inhibitor, for the treatment of adults with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. It can be used alone or in combination with methotrexate or other disease modifying antirheumatic drugs (DMARDs) and is administered intravenously every 4 weeks.

LITHE was an international randomized, double-blind placebo-controlled study. It was designed to determine how the efficacy of the two approved tocilizumab doses (4 mg/kg or 8 mg/kg) every 4 weeks in combination with methotrexate compared with methotrexate plus placebo in 1,196 patients with moderately to severely active RA who had an inadequate response to methotrexate alone over 2 years. The 52-week results, according to Genentech, include the following:

• Sixty-three percent of the patients on the 8-mg/kg dose plus methotrexate and 60% of those on the 4-mg/kg dose plus methotrexate achieved a "clinically relevant" improvement on the Health Assessment Questionnaire-Disability Index (HAQ-DI), used to assess changes in physical function with questions about different categories of physical functioning, compared with 53% of those on methotrexate plus placebo, a significant difference between the treatment and placebo groups.

• Changes from baseline in Genant-modified Sharp scores, a radiographic score based on evaluation of different sites for bone erosion and joint space narrowing, indicated that the 4-mg/kg dose "slowed" the progression of structural joint damage (less than 75% inhibition compared with the control group) and that the 8-mg/kg dose "inhibited" the progression of structural damage (at least 75% inhibition compared with the control group).

• Seven percent of those on the 8-mg/kg dose and 4% of those on 4-mg/kg dose plus methotrexate had achieved a major clinical response (a 70% improvement in American College of Rheumatology response criteria for a continuous 24-week period) compared with 1% of those on placebo plus methotrexate.

Safety was similar to that in previous studies of the drug. Because of the increased risk for serious, potentially fatal infections associated with treatment, tocilizumab was approved in 2010 with a Risk Evaluation and Mitigation Strategy (REMS) to minimize this risk.

The recommended starting dose of tocilizumab is 4 mg/kg, increasing to 8 mg/kg based on the patient’s clinical response, according to the prescribing information. Tocilizumab is marketed as RoActemra in the European Union and is also approved in India, Brazil, Switzerland, and Australia, and several other countries, according to Genentech. It was approved in Japan in 2005.

Serious adverse reactions to tocilizumab can be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has expanded its approval of tocilizumab to include labeling claims regarding the biologic drug’s effects on joint damage, physical function, and major clinical response in people with rheumatoid arthritis, according to the manufacturer, Genentech Inc.

On Jan. 5, Genentech announced that the FDA had approved the addition of the following information to the tocilizumab prescribing label, based on data from the LITHE (Tocilizumab Safety and the Prevention of Structural Joint Damage) study: inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adults with moderately to severely active RA treated with tocilizumab and methotrexate.

The supplemental approval comes a year after the FDA approved tocilizumab, an interleukin-6 receptor inhibitor, for the treatment of adults with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. It can be used alone or in combination with methotrexate or other disease modifying antirheumatic drugs (DMARDs) and is administered intravenously every 4 weeks.

LITHE was an international randomized, double-blind placebo-controlled study. It was designed to determine how the efficacy of the two approved tocilizumab doses (4 mg/kg or 8 mg/kg) every 4 weeks in combination with methotrexate compared with methotrexate plus placebo in 1,196 patients with moderately to severely active RA who had an inadequate response to methotrexate alone over 2 years. The 52-week results, according to Genentech, include the following:

• Sixty-three percent of the patients on the 8-mg/kg dose plus methotrexate and 60% of those on the 4-mg/kg dose plus methotrexate achieved a "clinically relevant" improvement on the Health Assessment Questionnaire-Disability Index (HAQ-DI), used to assess changes in physical function with questions about different categories of physical functioning, compared with 53% of those on methotrexate plus placebo, a significant difference between the treatment and placebo groups.

• Changes from baseline in Genant-modified Sharp scores, a radiographic score based on evaluation of different sites for bone erosion and joint space narrowing, indicated that the 4-mg/kg dose "slowed" the progression of structural joint damage (less than 75% inhibition compared with the control group) and that the 8-mg/kg dose "inhibited" the progression of structural damage (at least 75% inhibition compared with the control group).

• Seven percent of those on the 8-mg/kg dose and 4% of those on 4-mg/kg dose plus methotrexate had achieved a major clinical response (a 70% improvement in American College of Rheumatology response criteria for a continuous 24-week period) compared with 1% of those on placebo plus methotrexate.

Safety was similar to that in previous studies of the drug. Because of the increased risk for serious, potentially fatal infections associated with treatment, tocilizumab was approved in 2010 with a Risk Evaluation and Mitigation Strategy (REMS) to minimize this risk.

The recommended starting dose of tocilizumab is 4 mg/kg, increasing to 8 mg/kg based on the patient’s clinical response, according to the prescribing information. Tocilizumab is marketed as RoActemra in the European Union and is also approved in India, Brazil, Switzerland, and Australia, and several other countries, according to Genentech. It was approved in Japan in 2005.

Serious adverse reactions to tocilizumab can be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has expanded its approval of tocilizumab to include labeling claims regarding the biologic drug’s effects on joint damage, physical function, and major clinical response in people with rheumatoid arthritis, according to the manufacturer, Genentech Inc.

On Jan. 5, Genentech announced that the FDA had approved the addition of the following information to the tocilizumab prescribing label, based on data from the LITHE (Tocilizumab Safety and the Prevention of Structural Joint Damage) study: inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adults with moderately to severely active RA treated with tocilizumab and methotrexate.

The supplemental approval comes a year after the FDA approved tocilizumab, an interleukin-6 receptor inhibitor, for the treatment of adults with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. It can be used alone or in combination with methotrexate or other disease modifying antirheumatic drugs (DMARDs) and is administered intravenously every 4 weeks.

LITHE was an international randomized, double-blind placebo-controlled study. It was designed to determine how the efficacy of the two approved tocilizumab doses (4 mg/kg or 8 mg/kg) every 4 weeks in combination with methotrexate compared with methotrexate plus placebo in 1,196 patients with moderately to severely active RA who had an inadequate response to methotrexate alone over 2 years. The 52-week results, according to Genentech, include the following:

• Sixty-three percent of the patients on the 8-mg/kg dose plus methotrexate and 60% of those on the 4-mg/kg dose plus methotrexate achieved a "clinically relevant" improvement on the Health Assessment Questionnaire-Disability Index (HAQ-DI), used to assess changes in physical function with questions about different categories of physical functioning, compared with 53% of those on methotrexate plus placebo, a significant difference between the treatment and placebo groups.

• Changes from baseline in Genant-modified Sharp scores, a radiographic score based on evaluation of different sites for bone erosion and joint space narrowing, indicated that the 4-mg/kg dose "slowed" the progression of structural joint damage (less than 75% inhibition compared with the control group) and that the 8-mg/kg dose "inhibited" the progression of structural damage (at least 75% inhibition compared with the control group).

• Seven percent of those on the 8-mg/kg dose and 4% of those on 4-mg/kg dose plus methotrexate had achieved a major clinical response (a 70% improvement in American College of Rheumatology response criteria for a continuous 24-week period) compared with 1% of those on placebo plus methotrexate.

Safety was similar to that in previous studies of the drug. Because of the increased risk for serious, potentially fatal infections associated with treatment, tocilizumab was approved in 2010 with a Risk Evaluation and Mitigation Strategy (REMS) to minimize this risk.

The recommended starting dose of tocilizumab is 4 mg/kg, increasing to 8 mg/kg based on the patient’s clinical response, according to the prescribing information. Tocilizumab is marketed as RoActemra in the European Union and is also approved in India, Brazil, Switzerland, and Australia, and several other countries, according to Genentech. It was approved in Japan in 2005.

Serious adverse reactions to tocilizumab can be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.

The Food and Drug Administration has asked manufacturers of prescription pain products containing acetaminophen to include no more than 325 mg of the drug in each capsule, tablet, or other dosage unit.

According to a safety announcement issued Jan. 13 by the agency, the action was taken to address the ongoing problem of acetaminophen overdose, a leading cause of severe liver injury in the United States.

In addition, the FDA requests that manufacturers of these combination products – including Vicodin and Percocet – add a boxed warning to product labels about the potential risk of severe liver injury if acetaminophen is taken in excessive doses or with alcohol.

Manufacturers have until January 2014 to comply with the recommendations, so a shortage of these medications is not anticipated, according to the agency.

The FDA is also asking clinicians to educate their patients about the dangers of acetaminophen overdose and advising them to take no more than the maximum daily dose of acetaminophen (4,000 mg).

"For physicians and other health care providers, we want to emphasize that it’s important to talk to patients and make sure that they are aware of the risks of using prescription pain medicines with acetaminophen," Dr. Sandra Kweder said during a press briefing. "Health care professionals should also make sure their patients know how much acetaminophen is contained in any prescription product," added Dr. Kweder, deputy director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. By limiting the amount of acetaminophen contained in each dose, "we don’t believe we are making these products less effective," she said, noting that the doses of the drug in these products have gradually "crept up" over the past few decades.

Currently, prescription acetaminophen products contain up to 750 mg of acetaminophen per dosage unit, but there are no data indicating that more than 325 mg of acetaminophen per unit provides greater pain relief, according to the FDA.

The agency’s request does not apply to OTC products, which can contain as much as 500 mg per tablet or capsule in the products marketed as extra strength. Information about the risk of liver injury already is required on the label for OTC products containing acetaminophen. The FDA announcement noted that the agency continues to evaluate ways to reduce the risk of acetaminophen-related liver injury from OTC products.

Almost half of acetaminophen-related cases of liver failure in the United States are caused by overdoses from prescription opioid-acetaminophen products, which are among the most commonly prescribed products in the United States, accounting for almost 200 million prescriptions dispensed per year.

Serious adverse events associated with acetaminophen or products that contain acetaminophen should be reported to the FDA’s MedWatch program online or at 800-332-1088.