Elizabeth Mechcatie

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA's General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices. The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as class I devices, the lowest risk category. (Band-Aids are also regulated as class I devices.)

Panelists were divided between recommending reclassifying tanning devices as class II devices, which require special controls, or as class III, the highest risk category. Examples of class II devices include medical lasers and UV lamps used to treat dermatologic disorders; class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was the president of the AAD, Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices. The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are aged 16-29. A total of 24% of female adolescents aged 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure from tanning lamps.

Disclosures: Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion.

Go to www.youtube.com/ElsGlobalMedicalNews

Most of the FDA panelists and members of the AAD support a ban on use of indoor tanning beds by people younger than 18.

Source ©Vidmantas/iStockphoto.com

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA's General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices. The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as class I devices, the lowest risk category. (Band-Aids are also regulated as class I devices.)

Panelists were divided between recommending reclassifying tanning devices as class II devices, which require special controls, or as class III, the highest risk category. Examples of class II devices include medical lasers and UV lamps used to treat dermatologic disorders; class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was the president of the AAD, Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices. The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are aged 16-29. A total of 24% of female adolescents aged 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure from tanning lamps.

Disclosures: Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion.

Go to www.youtube.com/ElsGlobalMedicalNews

Most of the FDA panelists and members of the AAD support a ban on use of indoor tanning beds by people younger than 18.

Source ©Vidmantas/iStockphoto.com

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA's General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices. The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as class I devices, the lowest risk category. (Band-Aids are also regulated as class I devices.)

Panelists were divided between recommending reclassifying tanning devices as class II devices, which require special controls, or as class III, the highest risk category. Examples of class II devices include medical lasers and UV lamps used to treat dermatologic disorders; class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was the president of the AAD, Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices. The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are aged 16-29. A total of 24% of female adolescents aged 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure from tanning lamps.

Disclosures: Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion.

Go to www.youtube.com/ElsGlobalMedicalNews

Most of the FDA panelists and members of the AAD support a ban on use of indoor tanning beds by people younger than 18.

Source ©Vidmantas/iStockphoto.com

An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.

The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."

Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.

Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.

In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.

The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.

An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.

The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."

Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.

Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.

In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.

The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.

An extended shortage of mechlorethamine hydrochloride, a nitrogen mustard used in chemotherapy for hematologic cancers - and for treating mycosis fungoides - is expected to begin this month, the Food and Drug Administration announced today.

The limited supply of mechlorethamine hydrochloride (Mustargen) will be allocated to patients already being treated with the chemotherapy drug, the agency said in a statement advising that "alternative treatment plans should be made for new patients to avoid interruption to a treatment program that would normally include Mustargen."

Once the current supply of Mustargen is depleted in mid to late April, the shortage of the drug is expected to last until "early 2011," according to the FDA. The existing supply will be distributed by Lundbeck Inc., the only manufacturer of the agent in the world, "to meet current patient needs, with priority given to sites with patients currently receiving Mustargen." No other supplies could be found.

Mustargen, the first chemotherapy drug approved by the FDA in 1949, is a component of the MOPP (Mustargen, Oncovin, procarbazine, and prednisone) regimen pioneered in the mid 1960s for advanced Hodgkin's disease. It is still used as a treatment for Hodgkin's disease, alone or in combination with radiation, as well as for polycythemia vera, mycosis fungoides, and bronchogenic carcinoma.

In an April 1 letter to healthcare professionals, Dr. Mark Weinberg, vice president of U.S. medical affairs at Lundbeck, said the remaining supply of Mustargen is "very limited in terms of quality and dating." The company will make the product available until the inventory is depleted, and is encouraging physicians to "consider alternative therapy rather than starting a new course of therapy with Mustargen," he added.

The shortage is related to unsuccessful attempts to transfer the manufacturing of Mustargen to a new manufacturer over the past several years, and the recent decision by a new contractor not to pursue commercial manufacturing, according to the letter. The company is transferring the manufacturing to another site, and is "confident" that the new manufacturer will produce a "high quality product." That is not expected to be approved before 2011, however.

GAITHERSBURG, MD. — Members of a Food and Drug Administration advisory panel agreed that although there are technological issues with insulin infusion pumps, these issues are outweighed by user-related issues.

The meeting of the FDA's General Hospital and Personal Use Devices Panel meeting was convened to discuss postmarketing reports of safety issues related to insulin infusion pumps in people with diabetes. These reports are from the FDA adverse event reporting database for devices. The panel was not asked to vote on any questions related to the topic.

Several endocrinologists on the panel stressed the importance of education for patients who receive an insulin pump in how well they do on insulin pump therapy, which is most commonly used in patients with type 1 diabetes.

Panelist Dr. Lamont Weide, an endocrinologist at Truman Medical Center, Kansas City, Mo., said that pump failure rates “seem to be very low” and that problems are usually patient driven.

Between Oct. 1, 2006, and Sept. 20, 2009, the FDA received 16,849 reports of adverse events associated with insulin pumps; most of the reports were provided by the manufacturers. At the meeting, the FDA presented information on the 16,797 reported events (including 310 deaths) for pumps made by the five top manufacturers.

The reports were far from complete: In most cases the problem with the pump was not described nor was the patient's age included; the cause of deaths associated with the pumps had not been thoroughly investigated or evaluated, according to the FDA. In approximately 20% of the reports, the problem with the device was listed as “unknown,” and in 9% the problem was listed as “replace.” These were the two most common explanations listed among the device problems reports. And as panelists pointed out, there is no denominator so event rates cannot be calculated.

The other most common problems listed were described as display of an error message on the device (almost 5%), failure to deliver (3%), and repair (3%). Less commonly reported problems included inaudible alarms, failure to prime or infuse, battery failure, or a blank screen.

The most commonly reported patient-related problems included hospitalization (21% of reports) and high blood glucose (almost 17% of reports). The other most commonly reported problems in patients included diabetic ketoacidosis (8%), hyperglycemia (8%), and low blood glucose (almost 5%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

Safety issues included the scenario of a pump recall or pump dysfunction and the risk associated with a patient having to change the mode of insulin treatment to insulin injections while waiting for a new pump. In the short-term (within 48 hours), the time usually needed by a manufacturer to provide a patient with a new pump, panelists said the risks were minimal, provided that patients and their families had been educated about what to do in that situation and had nonexpired insulin available for injections. The long-term risks include poorer glucose control, since insulin pumps provide better glucose control and a lower risk of hypoglycemia than do multiple daily injections, according to panelists.

When asked about the relative risks associated with the continuing use of a defective pump, panelists said that a pump failure that results in overinfusion of insulin and the risk of severe hypoglycemia would be their biggest concern, particularly during the night, when patients who do not have a glucose sensor are not testing their blood glucose.

Advisory panel members have been screened for potential conflicts of interest related to the products under discussion prior to panel meetings.

GAITHERSBURG, MD. — Members of a Food and Drug Administration advisory panel agreed that although there are technological issues with insulin infusion pumps, these issues are outweighed by user-related issues.

The meeting of the FDA's General Hospital and Personal Use Devices Panel meeting was convened to discuss postmarketing reports of safety issues related to insulin infusion pumps in people with diabetes. These reports are from the FDA adverse event reporting database for devices. The panel was not asked to vote on any questions related to the topic.

Several endocrinologists on the panel stressed the importance of education for patients who receive an insulin pump in how well they do on insulin pump therapy, which is most commonly used in patients with type 1 diabetes.

Panelist Dr. Lamont Weide, an endocrinologist at Truman Medical Center, Kansas City, Mo., said that pump failure rates “seem to be very low” and that problems are usually patient driven.

Between Oct. 1, 2006, and Sept. 20, 2009, the FDA received 16,849 reports of adverse events associated with insulin pumps; most of the reports were provided by the manufacturers. At the meeting, the FDA presented information on the 16,797 reported events (including 310 deaths) for pumps made by the five top manufacturers.

The reports were far from complete: In most cases the problem with the pump was not described nor was the patient's age included; the cause of deaths associated with the pumps had not been thoroughly investigated or evaluated, according to the FDA. In approximately 20% of the reports, the problem with the device was listed as “unknown,” and in 9% the problem was listed as “replace.” These were the two most common explanations listed among the device problems reports. And as panelists pointed out, there is no denominator so event rates cannot be calculated.

The other most common problems listed were described as display of an error message on the device (almost 5%), failure to deliver (3%), and repair (3%). Less commonly reported problems included inaudible alarms, failure to prime or infuse, battery failure, or a blank screen.

The most commonly reported patient-related problems included hospitalization (21% of reports) and high blood glucose (almost 17% of reports). The other most commonly reported problems in patients included diabetic ketoacidosis (8%), hyperglycemia (8%), and low blood glucose (almost 5%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

Safety issues included the scenario of a pump recall or pump dysfunction and the risk associated with a patient having to change the mode of insulin treatment to insulin injections while waiting for a new pump. In the short-term (within 48 hours), the time usually needed by a manufacturer to provide a patient with a new pump, panelists said the risks were minimal, provided that patients and their families had been educated about what to do in that situation and had nonexpired insulin available for injections. The long-term risks include poorer glucose control, since insulin pumps provide better glucose control and a lower risk of hypoglycemia than do multiple daily injections, according to panelists.

When asked about the relative risks associated with the continuing use of a defective pump, panelists said that a pump failure that results in overinfusion of insulin and the risk of severe hypoglycemia would be their biggest concern, particularly during the night, when patients who do not have a glucose sensor are not testing their blood glucose.

Advisory panel members have been screened for potential conflicts of interest related to the products under discussion prior to panel meetings.

GAITHERSBURG, MD. — Members of a Food and Drug Administration advisory panel agreed that although there are technological issues with insulin infusion pumps, these issues are outweighed by user-related issues.

The meeting of the FDA's General Hospital and Personal Use Devices Panel meeting was convened to discuss postmarketing reports of safety issues related to insulin infusion pumps in people with diabetes. These reports are from the FDA adverse event reporting database for devices. The panel was not asked to vote on any questions related to the topic.

Several endocrinologists on the panel stressed the importance of education for patients who receive an insulin pump in how well they do on insulin pump therapy, which is most commonly used in patients with type 1 diabetes.

Panelist Dr. Lamont Weide, an endocrinologist at Truman Medical Center, Kansas City, Mo., said that pump failure rates “seem to be very low” and that problems are usually patient driven.

Between Oct. 1, 2006, and Sept. 20, 2009, the FDA received 16,849 reports of adverse events associated with insulin pumps; most of the reports were provided by the manufacturers. At the meeting, the FDA presented information on the 16,797 reported events (including 310 deaths) for pumps made by the five top manufacturers.

The reports were far from complete: In most cases the problem with the pump was not described nor was the patient's age included; the cause of deaths associated with the pumps had not been thoroughly investigated or evaluated, according to the FDA. In approximately 20% of the reports, the problem with the device was listed as “unknown,” and in 9% the problem was listed as “replace.” These were the two most common explanations listed among the device problems reports. And as panelists pointed out, there is no denominator so event rates cannot be calculated.

The other most common problems listed were described as display of an error message on the device (almost 5%), failure to deliver (3%), and repair (3%). Less commonly reported problems included inaudible alarms, failure to prime or infuse, battery failure, or a blank screen.

The most commonly reported patient-related problems included hospitalization (21% of reports) and high blood glucose (almost 17% of reports). The other most commonly reported problems in patients included diabetic ketoacidosis (8%), hyperglycemia (8%), and low blood glucose (almost 5%).

Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.

Safety issues included the scenario of a pump recall or pump dysfunction and the risk associated with a patient having to change the mode of insulin treatment to insulin injections while waiting for a new pump. In the short-term (within 48 hours), the time usually needed by a manufacturer to provide a patient with a new pump, panelists said the risks were minimal, provided that patients and their families had been educated about what to do in that situation and had nonexpired insulin available for injections. The long-term risks include poorer glucose control, since insulin pumps provide better glucose control and a lower risk of hypoglycemia than do multiple daily injections, according to panelists.

When asked about the relative risks associated with the continuing use of a defective pump, panelists said that a pump failure that results in overinfusion of insulin and the risk of severe hypoglycemia would be their biggest concern, particularly during the night, when patients who do not have a glucose sensor are not testing their blood glucose.

Advisory panel members have been screened for potential conflicts of interest related to the products under discussion prior to panel meetings.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting of the FDA's General and Plastic Surgery Devices Panel, most members supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices.

Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category.

Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13–19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting of the FDA's General and Plastic Surgery Devices Panel, most members supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices.

Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category.

Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13–19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting of the FDA's General and Plastic Surgery Devices Panel, most members supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning. Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent.

The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices.

Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category.

Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13–19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there's evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

GAITHERSBURG, Md. – A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA’s General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning.

Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent. The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices. Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category. Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there’s evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Standards for indoor tanning devices in Europe are more restrictive than in the United States and include age restrictions and requirements for informed consent in some countries, according to the FDA.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

Photo credit: Markette Smith

GAITHERSBURG, Md. – A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA’s General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning.

Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent. The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices. Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category. Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there’s evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Standards for indoor tanning devices in Europe are more restrictive than in the United States and include age restrictions and requirements for informed consent in some countries, according to the FDA.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

Photo credit: Markette Smith

GAITHERSBURG, Md. – A Food and Drug Administration advisory panel has recommended tougher restrictions on indoor tanning devices, including a ban on their use by people under age 18.

At a meeting March 25, most members of the FDA’s General and Plastic Surgery Devices Panel supported such a ban as one measure to address the widespread use and potential skin cancer risks of indoor tanning.

Other panelists recommended different controls to protect this age group from exposure to these devices, including required informed parental consent. The FDA usually follows the recommendations of its advisory panels, which are not binding.

The meeting was held to discuss whether current labeling of tanning beds and lamps adequately addresses their known risks and to discuss increasing concerns about the heightened skin cancer risks associated with the devices.

The advisory panel unanimously recommended moving indoor tanning devices to a higher risk category, subjecting them to more controls and requirements.

Currently, UV lamps and beds used for tanning are regulated by the FDA as Class I devices, the lowest risk category. Band-Aids are also regulated as Class I devices. Panelists were divided between recommending reclassifying tanning devices as Class II devices, which require special controls, or as Class III, the highest risk category. Examples of Class II devices include medical lasers and UV lamps used to treat dermatologic disorders; Class III devices include breast implants and injectable cosmetic fillers.

The American Academy of Dermatology and other medical associations recommend a broad ban on the sale and use of these products for tanning, but at a minimum, the AAD says, they should be banned for use in minors under age 18.

Among those speaking during the public hearing portion of the meeting was AAD President Dr. William James of the University of Pennsylvania, Philadelphia, who said that dermatologists are seeing more young women with advanced skin cancer, including melanoma, who have used indoor tanning devices.

The chief of the dermatology service at Memorial-Sloan Kettering, New York, Dr. Allan Halpern, testified that 25% of melanomas in young women could be attributed to UV tanning bed use.

Of the more than 1 million people per day in the United States who are exposed to UV radiation from indoor tanning devices, 70% are women, and most are between ages 16 and 29. A total of 24% of female adolescents ages 13-19 have used a tanning bed at least once in the previous year, according to the AAD.

FDA officials at the meeting said they believe there’s evidence of a potential raised risk for skin cancer associated with increased UV exposure acquired with UV tanning lamps.

Standards for indoor tanning devices in Europe are more restrictive than in the United States and include age restrictions and requirements for informed consent in some countries, according to the FDA.

Members of FDA advisory panels have been cleared of potential conflicts of interest related to the products under discussion prior to the meeting.

Photo credit: Markette Smith

BETHESDA, MD. — The influenza vaccine for the 2010–2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration Advisory Panel recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee last month, the panel unanimously voted that the current influenza A(H1N1) strain included in the 2009–2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine that has been used this deason.

Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, Atlanta, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010–2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine, with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

BETHESDA, MD. — The influenza vaccine for the 2010–2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration Advisory Panel recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee last month, the panel unanimously voted that the current influenza A(H1N1) strain included in the 2009–2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine that has been used this deason.

Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, Atlanta, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010–2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine, with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

BETHESDA, MD. — The influenza vaccine for the 2010–2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration Advisory Panel recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee last month, the panel unanimously voted that the current influenza A(H1N1) strain included in the 2009–2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine that has been used this deason.

Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, Atlanta, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010–2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine, with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

BETHESDA, MD. — The influenza vaccine for the 2010-2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration advisory panel has recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel unanimously voted 12-0 that the current influenza A(H1N1) strain included in the 2009-2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine used this past season. Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses, which “most likely pose a low risk” in the forthcoming season in the northern hemisphere.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010-2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is used in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said. She pointed out, however, that it is always difficult to predict which lineage of influenza B viruses will predominate.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

Seasonal A(H1N1) influenza viruses 'most likely pose a low risk' in the forthcoming season.

Source: DR. COX

BETHESDA, MD. — The influenza vaccine for the 2010-2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration advisory panel has recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel unanimously voted 12-0 that the current influenza A(H1N1) strain included in the 2009-2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine used this past season. Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses, which “most likely pose a low risk” in the forthcoming season in the northern hemisphere.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010-2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is used in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said. She pointed out, however, that it is always difficult to predict which lineage of influenza B viruses will predominate.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

Seasonal A(H1N1) influenza viruses 'most likely pose a low risk' in the forthcoming season.

Source: DR. COX

BETHESDA, MD. — The influenza vaccine for the 2010-2011 influenza season in the United States should include a pandemic influenza A(H1N1) strain, instead of one of the two seasonal influenza A strains in the current vaccine, a Food and Drug Administration advisory panel has recommended.

At a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, the panel unanimously voted 12-0 that the current influenza A(H1N1) strain included in the 2009-2010 seasonal flu vaccine, an A/Brisbane/59/2007 (H1N1)–like virus, should be replaced with a pandemic A(H1N1) vaccine virus, an A/California/7/2009–like virus, the component of the monovalent pandemic vaccine used this past season. Also included in the vaccine should be an A/Perth/16/2009 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (B/Victoria lineage), the panel said.

The panel's recommendation is based on the finding that the vast majority of influenza A(H1N1) viruses circulating worldwide have been the pandemic strain. At the meeting, Nancy Cox, Ph.D., director of the influenza division at the Centers for Disease Control and Prevention, told the panel that there has been very little evidence of circulating seasonal A(H1N1) influenza viruses, which “most likely pose a low risk” in the forthcoming season in the northern hemisphere.

The panel meets every year at this time to make preliminary recommendations on the components of the trivalent vaccine for the forthcoming influenza season in the northern hemisphere. It considered information on the strains circulating worldwide as well as recommendations announced by the World Health Organization for the 2010-2011 influenza vaccine to be used in the northern hemisphere.

The panel voted to replace the influenza A(H3N2) strain included in the current vaccine with a southern hemisphere vaccine virus A/Perth/16/2009 (H3N2)–like virus. Dr. Cox said that activity of seasonal A(H3N2) viruses has been “relatively low” worldwide, compared with previous years, and what has been circulating antigenically is closely related to the A/Perth/16/2009 virus.

The panel voted to retain the influenza B component that is used in the current vaccine, a B/Brisbane/60/2008–like virus (B/Victoria lineage). Influenza B viruses have been circulating at low levels in many countries, but Victoria lineage viruses continue to predominate, Dr. Cox said. She pointed out, however, that it is always difficult to predict which lineage of influenza B viruses will predominate.

The panel's recommendations were the same as the WHO recommendations for the three components of the influenza vaccine for the forthcoming season in the northern hemisphere.

Seasonal A(H1N1) influenza viruses 'most likely pose a low risk' in the forthcoming season.

Source: DR. COX

The Food and Drug Administration is requiring major changes to the prescribing information for inhaled long-acting beta agonists as part of a risk management plan to address the ongoing safety issues associated with the products' use in children and adults with asthma, the agency said at a press briefing.

Safety concerns regarding long-acting beta agonist (LABA) therapy date back to a major study reported more than 7 years ago, and a 2008 FDA meta-analysis indicated that treatment with LABAs—either alone or combined with an inhaled corticosteroid (ICS)—is associated with an increased risk of severe asthma symptoms and hospitalizations as well as deaths in adults and children with asthma, compared with people not on a LABA.

The LABA products approved in the United States are Serevent (salmeterol) and Foradil Aformoterol), which contain the LABA alone, and Advair HFA(salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an ICS.

Previous efforts to address these risks, including a boxed warning added in 2003, have not adequately addressed the safety issue, so the FDA is requiring label changes as part of a risk evaluation and mitigation strategy (REMS) for these products. The changes are “intended to better inform health care providers and patients with asthma about the risks of LABAs and the way they can decrease these risks while maintaining the benefits” of these drugs, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said at the briefing.

The new labeling states that:

▸ LABAs are not asthma-controller medications and are contraindicated without the use of an asthma-controller medication, such as an ICS. Single-agent LABAs should be used only with a controller medication, never alone.

▸ A LABA should be used only as long-term treatment in patients whose asthma cannot be adequately controlled on asthma-controller medications.

▸ Children and adolescents who need a LABA with an ICS should be prescribed one of the combination products, to ensure that a LABA is not used alone.

▸ LABAs should be used for the shortest period of time possible to achieve symptom control. As soon as a patient's asthma is under control, the LABA should be discontinued “if possible,” and the patient should be maintained on an asthma-controller medication, such as an ICS. This is a change from current asthma treatment guidelines.

The REMS for these products includes a revised medication guide for patients that explains the product risks with each filled prescription, a plan to educate health care providers about the appropriate use of LABAs, and a requirement that the manufacturers conduct more studies of the safety of the LABA-ICS combination products.

Currently there are insufficient data to conclude whether LABAs combined with an ICS “reduces or eliminates the risk of asthma-related death and hospitalizations,” the FDA statement said.

Under a recently launched drug safety initiative, the FDA will monitor the use of LABAs to determine whether they are still being used without a controller drug.

The new requirements do not apply to the use of LABAs for chronic obstructive pulmonary disease or intermittent exercise-induced broncospasm.

The full statement is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm

The Food and Drug Administration is requiring major changes to the prescribing information for inhaled long-acting beta agonists as part of a risk management plan to address the ongoing safety issues associated with the products' use in children and adults with asthma, the agency said at a press briefing.

Safety concerns regarding long-acting beta agonist (LABA) therapy date back to a major study reported more than 7 years ago, and a 2008 FDA meta-analysis indicated that treatment with LABAs—either alone or combined with an inhaled corticosteroid (ICS)—is associated with an increased risk of severe asthma symptoms and hospitalizations as well as deaths in adults and children with asthma, compared with people not on a LABA.

The LABA products approved in the United States are Serevent (salmeterol) and Foradil Aformoterol), which contain the LABA alone, and Advair HFA(salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an ICS.

Previous efforts to address these risks, including a boxed warning added in 2003, have not adequately addressed the safety issue, so the FDA is requiring label changes as part of a risk evaluation and mitigation strategy (REMS) for these products. The changes are “intended to better inform health care providers and patients with asthma about the risks of LABAs and the way they can decrease these risks while maintaining the benefits” of these drugs, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said at the briefing.

The new labeling states that:

▸ LABAs are not asthma-controller medications and are contraindicated without the use of an asthma-controller medication, such as an ICS. Single-agent LABAs should be used only with a controller medication, never alone.

▸ A LABA should be used only as long-term treatment in patients whose asthma cannot be adequately controlled on asthma-controller medications.

▸ Children and adolescents who need a LABA with an ICS should be prescribed one of the combination products, to ensure that a LABA is not used alone.

▸ LABAs should be used for the shortest period of time possible to achieve symptom control. As soon as a patient's asthma is under control, the LABA should be discontinued “if possible,” and the patient should be maintained on an asthma-controller medication, such as an ICS. This is a change from current asthma treatment guidelines.

The REMS for these products includes a revised medication guide for patients that explains the product risks with each filled prescription, a plan to educate health care providers about the appropriate use of LABAs, and a requirement that the manufacturers conduct more studies of the safety of the LABA-ICS combination products.

Currently there are insufficient data to conclude whether LABAs combined with an ICS “reduces or eliminates the risk of asthma-related death and hospitalizations,” the FDA statement said.

Under a recently launched drug safety initiative, the FDA will monitor the use of LABAs to determine whether they are still being used without a controller drug.

The new requirements do not apply to the use of LABAs for chronic obstructive pulmonary disease or intermittent exercise-induced broncospasm.

The full statement is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm

The Food and Drug Administration is requiring major changes to the prescribing information for inhaled long-acting beta agonists as part of a risk management plan to address the ongoing safety issues associated with the products' use in children and adults with asthma, the agency said at a press briefing.

Safety concerns regarding long-acting beta agonist (LABA) therapy date back to a major study reported more than 7 years ago, and a 2008 FDA meta-analysis indicated that treatment with LABAs—either alone or combined with an inhaled corticosteroid (ICS)—is associated with an increased risk of severe asthma symptoms and hospitalizations as well as deaths in adults and children with asthma, compared with people not on a LABA.

The LABA products approved in the United States are Serevent (salmeterol) and Foradil Aformoterol), which contain the LABA alone, and Advair HFA(salmeterol plus fluticasone) and Symbicort (formoterol plus budesonide), which contain the LABA and an ICS.

Previous efforts to address these risks, including a boxed warning added in 2003, have not adequately addressed the safety issue, so the FDA is requiring label changes as part of a risk evaluation and mitigation strategy (REMS) for these products. The changes are “intended to better inform health care providers and patients with asthma about the risks of LABAs and the way they can decrease these risks while maintaining the benefits” of these drugs, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said at the briefing.

The new labeling states that:

▸ LABAs are not asthma-controller medications and are contraindicated without the use of an asthma-controller medication, such as an ICS. Single-agent LABAs should be used only with a controller medication, never alone.

▸ A LABA should be used only as long-term treatment in patients whose asthma cannot be adequately controlled on asthma-controller medications.

▸ Children and adolescents who need a LABA with an ICS should be prescribed one of the combination products, to ensure that a LABA is not used alone.

▸ LABAs should be used for the shortest period of time possible to achieve symptom control. As soon as a patient's asthma is under control, the LABA should be discontinued “if possible,” and the patient should be maintained on an asthma-controller medication, such as an ICS. This is a change from current asthma treatment guidelines.

The REMS for these products includes a revised medication guide for patients that explains the product risks with each filled prescription, a plan to educate health care providers about the appropriate use of LABAs, and a requirement that the manufacturers conduct more studies of the safety of the LABA-ICS combination products.

Currently there are insufficient data to conclude whether LABAs combined with an ICS “reduces or eliminates the risk of asthma-related death and hospitalizations,” the FDA statement said.

Under a recently launched drug safety initiative, the FDA will monitor the use of LABAs to determine whether they are still being used without a controller drug.

The new requirements do not apply to the use of LABAs for chronic obstructive pulmonary disease or intermittent exercise-induced broncospasm.

The full statement is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm

The Food and Drug Administration has approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

The safety profile of lapatinib was similar to that observed in previous studies of women with advanced breast cancer. Diarrhea, rash, nausea, and fatigue were the most common side effects reported for the combination, according to the FDA.

Treatment with lapatinib has been associated with decreased left ventricular ejection fraction and hepatotoxicity, as well as interstitial lung disease and pneumonitis, and it can harm the fetus, the statement added.

Letrozole is marketed by Novartis.

The Food and Drug Administration has approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

The safety profile of lapatinib was similar to that observed in previous studies of women with advanced breast cancer. Diarrhea, rash, nausea, and fatigue were the most common side effects reported for the combination, according to the FDA.

Treatment with lapatinib has been associated with decreased left ventricular ejection fraction and hepatotoxicity, as well as interstitial lung disease and pneumonitis, and it can harm the fetus, the statement added.

Letrozole is marketed by Novartis.

The Food and Drug Administration has approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.

A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.

In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.

“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.

In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.

The safety profile of lapatinib was similar to that observed in previous studies of women with advanced breast cancer. Diarrhea, rash, nausea, and fatigue were the most common side effects reported for the combination, according to the FDA.

Treatment with lapatinib has been associated with decreased left ventricular ejection fraction and hepatotoxicity, as well as interstitial lung disease and pneumonitis, and it can harm the fetus, the statement added.

Letrozole is marketed by Novartis.

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/

The high risk of neural tube defects and other major malformations in babies exposed to valproate sodium and the related products, valproic acid and divalproex sodium, during the first trimester is the focus of a Food and Drug Administration notice to health care professionals.

The FDA statement also emphasizes the need for health practitioners to counsel women of childbearing potential about these teratogenic risks, and to “consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.”

The statement was posted on the FDA's MedWatch site in December.

The risk of a neural tube defect in a baby born to a mother who took valproate or one of the two related products during the first 12 weeks of pregnancy is 1 in 20, compared with the background rate of 1 in 1,500 in the United States, according to the FDA.

The notice cites data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which indicate that the major malformation rate in babies born to women who have epilepsy and take valproate alone is nearly fourfold greater than among the babies born to women with epilepsy who take a different antiepileptic: 10.7%, compared with 2.9%.

The 16 major malformations among the babies in the registry who were exposed to valproate during the first trimester of pregnancy included neural tube defects, craniofacial defects, cardiovascular malformations, and malformations involving other body systems.

Included in the FDA statement were comments on the importance of taking folic acid supplements before and during the first trimester of pregnancy in order to reduce the risk of neural tube defects, and a recommendation that women who are treated with one of these drugs and who are not planning a pregnancy use an effective method of contraception.

Valproic acid, which is marketed as Depakene and as Stavzor, was approved in 1978 for the treatment of epilepsy. Valproate, marketed as Depacon, was approved more recently for the treatment of bipolar disorder and migraine headaches.

“As valproate's indications for use expand, it is critical that health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects,” the FDA statement said.

“Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease is critical for informed prescribing and counseling of all women taking valproate.”

Divalproex sodium is marketed as Depakote, Depakote CP, and Depakote ER, and is approved for migraine prophylaxis, manic episodes associated with bipolar disorder, as well as epilepsy.

The FDA notice also includes an information section specific to patients.

The agency is working with the manufacturers of these products to make labeling changes that reflect the information regarding teratogenic risk.

The notice can be found at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htmwww.aedpregnancyregistry.orgwww.fda.gov/medwatch/