Elizabeth Mechcatie

Some blood glucose test strips being sold in the United States are counterfeit and potentially could provide patients with incorrect information on blood glucose values, according to an alert issued by the Food and Drug Administration.

Certain lots of two types of test strips used with different models of OneTouch-brand blood glucose monitors have been found to be counterfeit and are being voluntarily recalled by the manufacturer, LifeScan Inc. The counterfeit test strips are:

▸ OneTouch Basic/Profile (lot #272894A, 2619932, or 2606340) test strips. (The outer cartons of these strips have English, Greek and Portuguese text; and only 50-count packages are affected.)

▸ OneTouch Ultra (lot #2691191) test strips. (The outer cartons of these strips have English and French text; only 50-count packages are affected).

The counterfeit strips were distributed to stores and pharmacies across the country, but primarily were sold in Ohio, New York, Florida, Maryland, and Missouri by Medical Plastic Devices Inc., Pointe Claire, Que.; and Champion Sales Inc., Brooklyn, N.Y, according to the alert.

The FDA is advising consumers to stop using these counterfeit strips if they have purchased them, replace the strips immediately, and call their physicians. The company is advising customers to contact their original source of the strips for restitution.

The FDA, which is investigating this case, has not received any reports of injuries related to the counterfeit strips, but encourages physicians and others to report any adverse reactions associated with the use of this product and/or quality problems to the FDA's MedWatch program at 800-332-1088, or www.fda.gov/medwatch

LifeScan can be reached at 866-621-4855, if consumers have any questions. More information is also available at www.GenuineOneTouch.com

Some blood glucose test strips being sold in the United States are counterfeit and potentially could provide patients with incorrect information on blood glucose values, according to an alert issued by the Food and Drug Administration.

Certain lots of two types of test strips used with different models of OneTouch-brand blood glucose monitors have been found to be counterfeit and are being voluntarily recalled by the manufacturer, LifeScan Inc. The counterfeit test strips are:

▸ OneTouch Basic/Profile (lot #272894A, 2619932, or 2606340) test strips. (The outer cartons of these strips have English, Greek and Portuguese text; and only 50-count packages are affected.)

▸ OneTouch Ultra (lot #2691191) test strips. (The outer cartons of these strips have English and French text; only 50-count packages are affected).

The counterfeit strips were distributed to stores and pharmacies across the country, but primarily were sold in Ohio, New York, Florida, Maryland, and Missouri by Medical Plastic Devices Inc., Pointe Claire, Que.; and Champion Sales Inc., Brooklyn, N.Y, according to the alert.

The FDA is advising consumers to stop using these counterfeit strips if they have purchased them, replace the strips immediately, and call their physicians. The company is advising customers to contact their original source of the strips for restitution.

The FDA, which is investigating this case, has not received any reports of injuries related to the counterfeit strips, but encourages physicians and others to report any adverse reactions associated with the use of this product and/or quality problems to the FDA's MedWatch program at 800-332-1088, or www.fda.gov/medwatch

LifeScan can be reached at 866-621-4855, if consumers have any questions. More information is also available at www.GenuineOneTouch.com

Some blood glucose test strips being sold in the United States are counterfeit and potentially could provide patients with incorrect information on blood glucose values, according to an alert issued by the Food and Drug Administration.

Certain lots of two types of test strips used with different models of OneTouch-brand blood glucose monitors have been found to be counterfeit and are being voluntarily recalled by the manufacturer, LifeScan Inc. The counterfeit test strips are:

▸ OneTouch Basic/Profile (lot #272894A, 2619932, or 2606340) test strips. (The outer cartons of these strips have English, Greek and Portuguese text; and only 50-count packages are affected.)

▸ OneTouch Ultra (lot #2691191) test strips. (The outer cartons of these strips have English and French text; only 50-count packages are affected).

The counterfeit strips were distributed to stores and pharmacies across the country, but primarily were sold in Ohio, New York, Florida, Maryland, and Missouri by Medical Plastic Devices Inc., Pointe Claire, Que.; and Champion Sales Inc., Brooklyn, N.Y, according to the alert.

The FDA is advising consumers to stop using these counterfeit strips if they have purchased them, replace the strips immediately, and call their physicians. The company is advising customers to contact their original source of the strips for restitution.

The FDA, which is investigating this case, has not received any reports of injuries related to the counterfeit strips, but encourages physicians and others to report any adverse reactions associated with the use of this product and/or quality problems to the FDA's MedWatch program at 800-332-1088, or www.fda.gov/medwatch

LifeScan can be reached at 866-621-4855, if consumers have any questions. More information is also available at www.GenuineOneTouch.com

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the target of a campaign launched by U.S., Mexican, and Canadian government agencies.

The Food and Drug Administration and the Federal Trade Commission (FTC) announced in a statement that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign.

The FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Among the claims on the Web site, according to the letter, is the statement that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is on the FDA's Web site at http://www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the target of a campaign launched by U.S., Mexican, and Canadian government agencies.

The Food and Drug Administration and the Federal Trade Commission (FTC) announced in a statement that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign.

The FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Among the claims on the Web site, according to the letter, is the statement that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is on the FDA's Web site at http://www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the target of a campaign launched by U.S., Mexican, and Canadian government agencies.

The Food and Drug Administration and the Federal Trade Commission (FTC) announced in a statement that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign.

The FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Among the claims on the Web site, according to the letter, is the statement that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is on the FDA's Web site at http://www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

GAITHERSBURG, MD. — A 10% loss in potency over the shelf life of levothyroxine sodium products—the maximum amount allowed under current regulations—raises clinically significant concerns, and current potency specifications for these products should be tightened, according to a majority of two Food and Drug Administration advisory panels.

At a joint meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and its Advisory Committee for Pharmaceutical Science, panelists recommended in a 25–1 vote, with one abstention, that the potency specifications for levothyroxine products should be narrowed to a maximum loss of 5% over a product's shelf life. This would correspond to a 95%–105% potency specification (where the product must contain 95%–105% of the amount in the label until the expiration date, rather than the 90%–110% allowed under the current standards).

Representatives of three manufacturers—Mylan Laboratories Inc., Abbott Laboratories, and Genpharm Inc.—said that the companies supported the panel recommendations and had the capacity to meet the proposed new standard. The FDA usually follows the advice of its advisory panels, which are not binding. Jane Axelrad, associate director for regulatory policy at the FDA, said the agency could set a schedule to meet these requirements that would avoid disrupting the supply of these products.

Panelists also questioned the methods used to assess potency and deterioration of these products in the stability studies, submitted by the manufacturers of the seven marketed levothyroxine products at the FDA's request. The studies, which found up to 10% loss in potency over 8–12 months in some products, were conducted under controlled conditions at room temperature, and did not reflect real-life situations such as opening a bottle twice a day for several months; leaving it open; exposing the pills to moisture such as during steamy showers in bathrooms; transport; and other factors that can hasten pill degradation.

During the open public hearing session of the meeting, representatives from the Endocrine Society and the American Association of Clinical Endocrinologists (AACE) brought up the issue of bioequivalence between the products.

Background documents provided by the FDA stated that the agency acknowledges that “substantial variability in potency between levothyroxine sodium products … could raise clinical concerns,” but that it was “fundamental to first understand and to properly control consistency of dosing within a given product over time from prescription to prescription … before contemplating any action related to relationships between products.”

Levothyroxine sodium, a drug with a narrow therapeutic index, is widely prescribed for thyroid disorders, with more than 13 million prescriptions in the United States and about 1 of every 19 Americans taking levothyroxine daily, according to the FDA.

The stability studies submitted by the manufacturers evaluated the potency of all 12 tablet strengths of products at room temperature for lots manufactured between June 2003 and June 2005; the results disclosed at the meeting were blinded so that no product names were given.

Results were provided for three different strengths: 100 mcg and 125 mcg, the most widely prescribed strengths, and 25 mcg, prescribed to vulnerable populations, such as newborns and the elderly. For some products, there was up to a 10% loss of potency during the shelf life of a product, over 8–12 months, according to Eric Duffy, Ph.D., director of the division of postmarketing evaluation in the FDA's Office of New Drug Quality Assessment. Therefore, theoretically, a tablet could degrade to the point where it contained less thyroxine than a lower-strength tablet. For example, if a 150-mcg tablet lost 10% of its potency, it would contain 135 mcg of the active ingredient, which is below the 137-mcg dose, the next lowest available dose; this actually occurred in two stability studies, Dr. Duffy said.

Because these studies were done under ideal situations, with controlled temperature and humidity, it can be assumed that the “real-life stability profile” of these products would not be better than what was observed in these stability studies, he added. Levothyroxine tablets are typically subjected to a variety of factors that could affect stability, from the time the product is shipped from the manufacturer until it reaches the patient, with time spent in the warehouse, mailboxes, and pharmacies. Patients also store their tablets in various ways, often in a warm, moist environment such as a bathroom, but levothyroxine is known to be stable only when stored under tightly controlled conditions, in a sealed container, at or below room temperature, and kept dry.

“We have to ask for a higher set of standards” for a drug that comes in 12 dosage strengths and has such a narrow therapeutic index, said panelist Dr. Morris Schambelan, chief of the division of endocrinology at San Francisco General Hospital. Dr. Robert Tuttle, of the endocrine service at Memorial Sloan Kettering Cancer Center, New York, remarked that there was “no question” that a 10% change in dose would make a difference clinically in thyroid cancer patients, who take levothyroxine under very controlled conditions.

Panelist Arthur Kibbe, Ph.D., of the Nesbit School of Pharmacy, Wilkes University, Wilkes-Barre, Pa., said that if the potency levels of all these products on the market were tightened, the possibility of differences between products would also be lessened and would reduce the chance of adverse effects of switching from one product to another.

Dr. Jurgen Venitz, of the Virginia Commonwealth University School of Pharmacy, Richmond, said that as much as he supported the panel's recommendations, he felt that bioequivalence between products was really the bigger issue. One panelist referred to bioequivalence as “the 800-pound gorilla in the room.”

Speaking for AACE during the open public hearing, Dr. Jeffrey Garber, treasurer and chief of endocrinology at Harvard Vanguard Medical Associates, Boston, said that it has become “increasingly unlikely” that a patient will be given a therapeutically equivalent preparation, and that while the meeting was “a step in the right direction,” it did not address the broader issue of bioequivalence.

Speaking for the Endocrine Society, Dr. Leonard Wartofsky, president of the society, said that current FDA bioequivalence standards are not sensitive enough to detect small but meaningful differences between products, and that the FDA erred in allowing manufacturers to drop the warning that when a product is switched, patients need to call their physician and have their thyroid-stimulating hormone levels measured to retitrate their dose. He referred to a May 2005 meeting cosponsored by the FDA, American Thyroid Association, Endocrine Society, and AACE to review concerns about substitution and bioequivalence, and concerns that one product may be substituted for another—often unbeknownst to the physician—despite differences in potency.

GAITHERSBURG, MD. — A 10% loss in potency over the shelf life of levothyroxine sodium products—the maximum amount allowed under current regulations—raises clinically significant concerns, and current potency specifications for these products should be tightened, according to a majority of two Food and Drug Administration advisory panels.

At a joint meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and its Advisory Committee for Pharmaceutical Science, panelists recommended in a 25–1 vote, with one abstention, that the potency specifications for levothyroxine products should be narrowed to a maximum loss of 5% over a product's shelf life. This would correspond to a 95%–105% potency specification (where the product must contain 95%–105% of the amount in the label until the expiration date, rather than the 90%–110% allowed under the current standards).

Representatives of three manufacturers—Mylan Laboratories Inc., Abbott Laboratories, and Genpharm Inc.—said that the companies supported the panel recommendations and had the capacity to meet the proposed new standard. The FDA usually follows the advice of its advisory panels, which are not binding. Jane Axelrad, associate director for regulatory policy at the FDA, said the agency could set a schedule to meet these requirements that would avoid disrupting the supply of these products.

Panelists also questioned the methods used to assess potency and deterioration of these products in the stability studies, submitted by the manufacturers of the seven marketed levothyroxine products at the FDA's request. The studies, which found up to 10% loss in potency over 8–12 months in some products, were conducted under controlled conditions at room temperature, and did not reflect real-life situations such as opening a bottle twice a day for several months; leaving it open; exposing the pills to moisture such as during steamy showers in bathrooms; transport; and other factors that can hasten pill degradation.

During the open public hearing session of the meeting, representatives from the Endocrine Society and the American Association of Clinical Endocrinologists (AACE) brought up the issue of bioequivalence between the products.

Background documents provided by the FDA stated that the agency acknowledges that “substantial variability in potency between levothyroxine sodium products … could raise clinical concerns,” but that it was “fundamental to first understand and to properly control consistency of dosing within a given product over time from prescription to prescription … before contemplating any action related to relationships between products.”

Levothyroxine sodium, a drug with a narrow therapeutic index, is widely prescribed for thyroid disorders, with more than 13 million prescriptions in the United States and about 1 of every 19 Americans taking levothyroxine daily, according to the FDA.

The stability studies submitted by the manufacturers evaluated the potency of all 12 tablet strengths of products at room temperature for lots manufactured between June 2003 and June 2005; the results disclosed at the meeting were blinded so that no product names were given.

Results were provided for three different strengths: 100 mcg and 125 mcg, the most widely prescribed strengths, and 25 mcg, prescribed to vulnerable populations, such as newborns and the elderly. For some products, there was up to a 10% loss of potency during the shelf life of a product, over 8–12 months, according to Eric Duffy, Ph.D., director of the division of postmarketing evaluation in the FDA's Office of New Drug Quality Assessment. Therefore, theoretically, a tablet could degrade to the point where it contained less thyroxine than a lower-strength tablet. For example, if a 150-mcg tablet lost 10% of its potency, it would contain 135 mcg of the active ingredient, which is below the 137-mcg dose, the next lowest available dose; this actually occurred in two stability studies, Dr. Duffy said.

Because these studies were done under ideal situations, with controlled temperature and humidity, it can be assumed that the “real-life stability profile” of these products would not be better than what was observed in these stability studies, he added. Levothyroxine tablets are typically subjected to a variety of factors that could affect stability, from the time the product is shipped from the manufacturer until it reaches the patient, with time spent in the warehouse, mailboxes, and pharmacies. Patients also store their tablets in various ways, often in a warm, moist environment such as a bathroom, but levothyroxine is known to be stable only when stored under tightly controlled conditions, in a sealed container, at or below room temperature, and kept dry.

“We have to ask for a higher set of standards” for a drug that comes in 12 dosage strengths and has such a narrow therapeutic index, said panelist Dr. Morris Schambelan, chief of the division of endocrinology at San Francisco General Hospital. Dr. Robert Tuttle, of the endocrine service at Memorial Sloan Kettering Cancer Center, New York, remarked that there was “no question” that a 10% change in dose would make a difference clinically in thyroid cancer patients, who take levothyroxine under very controlled conditions.

Panelist Arthur Kibbe, Ph.D., of the Nesbit School of Pharmacy, Wilkes University, Wilkes-Barre, Pa., said that if the potency levels of all these products on the market were tightened, the possibility of differences between products would also be lessened and would reduce the chance of adverse effects of switching from one product to another.

Dr. Jurgen Venitz, of the Virginia Commonwealth University School of Pharmacy, Richmond, said that as much as he supported the panel's recommendations, he felt that bioequivalence between products was really the bigger issue. One panelist referred to bioequivalence as “the 800-pound gorilla in the room.”

Speaking for AACE during the open public hearing, Dr. Jeffrey Garber, treasurer and chief of endocrinology at Harvard Vanguard Medical Associates, Boston, said that it has become “increasingly unlikely” that a patient will be given a therapeutically equivalent preparation, and that while the meeting was “a step in the right direction,” it did not address the broader issue of bioequivalence.

Speaking for the Endocrine Society, Dr. Leonard Wartofsky, president of the society, said that current FDA bioequivalence standards are not sensitive enough to detect small but meaningful differences between products, and that the FDA erred in allowing manufacturers to drop the warning that when a product is switched, patients need to call their physician and have their thyroid-stimulating hormone levels measured to retitrate their dose. He referred to a May 2005 meeting cosponsored by the FDA, American Thyroid Association, Endocrine Society, and AACE to review concerns about substitution and bioequivalence, and concerns that one product may be substituted for another—often unbeknownst to the physician—despite differences in potency.

GAITHERSBURG, MD. — A 10% loss in potency over the shelf life of levothyroxine sodium products—the maximum amount allowed under current regulations—raises clinically significant concerns, and current potency specifications for these products should be tightened, according to a majority of two Food and Drug Administration advisory panels.

At a joint meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and its Advisory Committee for Pharmaceutical Science, panelists recommended in a 25–1 vote, with one abstention, that the potency specifications for levothyroxine products should be narrowed to a maximum loss of 5% over a product's shelf life. This would correspond to a 95%–105% potency specification (where the product must contain 95%–105% of the amount in the label until the expiration date, rather than the 90%–110% allowed under the current standards).

Representatives of three manufacturers—Mylan Laboratories Inc., Abbott Laboratories, and Genpharm Inc.—said that the companies supported the panel recommendations and had the capacity to meet the proposed new standard. The FDA usually follows the advice of its advisory panels, which are not binding. Jane Axelrad, associate director for regulatory policy at the FDA, said the agency could set a schedule to meet these requirements that would avoid disrupting the supply of these products.

Panelists also questioned the methods used to assess potency and deterioration of these products in the stability studies, submitted by the manufacturers of the seven marketed levothyroxine products at the FDA's request. The studies, which found up to 10% loss in potency over 8–12 months in some products, were conducted under controlled conditions at room temperature, and did not reflect real-life situations such as opening a bottle twice a day for several months; leaving it open; exposing the pills to moisture such as during steamy showers in bathrooms; transport; and other factors that can hasten pill degradation.

During the open public hearing session of the meeting, representatives from the Endocrine Society and the American Association of Clinical Endocrinologists (AACE) brought up the issue of bioequivalence between the products.

Background documents provided by the FDA stated that the agency acknowledges that “substantial variability in potency between levothyroxine sodium products … could raise clinical concerns,” but that it was “fundamental to first understand and to properly control consistency of dosing within a given product over time from prescription to prescription … before contemplating any action related to relationships between products.”

Levothyroxine sodium, a drug with a narrow therapeutic index, is widely prescribed for thyroid disorders, with more than 13 million prescriptions in the United States and about 1 of every 19 Americans taking levothyroxine daily, according to the FDA.

The stability studies submitted by the manufacturers evaluated the potency of all 12 tablet strengths of products at room temperature for lots manufactured between June 2003 and June 2005; the results disclosed at the meeting were blinded so that no product names were given.

Results were provided for three different strengths: 100 mcg and 125 mcg, the most widely prescribed strengths, and 25 mcg, prescribed to vulnerable populations, such as newborns and the elderly. For some products, there was up to a 10% loss of potency during the shelf life of a product, over 8–12 months, according to Eric Duffy, Ph.D., director of the division of postmarketing evaluation in the FDA's Office of New Drug Quality Assessment. Therefore, theoretically, a tablet could degrade to the point where it contained less thyroxine than a lower-strength tablet. For example, if a 150-mcg tablet lost 10% of its potency, it would contain 135 mcg of the active ingredient, which is below the 137-mcg dose, the next lowest available dose; this actually occurred in two stability studies, Dr. Duffy said.

Because these studies were done under ideal situations, with controlled temperature and humidity, it can be assumed that the “real-life stability profile” of these products would not be better than what was observed in these stability studies, he added. Levothyroxine tablets are typically subjected to a variety of factors that could affect stability, from the time the product is shipped from the manufacturer until it reaches the patient, with time spent in the warehouse, mailboxes, and pharmacies. Patients also store their tablets in various ways, often in a warm, moist environment such as a bathroom, but levothyroxine is known to be stable only when stored under tightly controlled conditions, in a sealed container, at or below room temperature, and kept dry.

“We have to ask for a higher set of standards” for a drug that comes in 12 dosage strengths and has such a narrow therapeutic index, said panelist Dr. Morris Schambelan, chief of the division of endocrinology at San Francisco General Hospital. Dr. Robert Tuttle, of the endocrine service at Memorial Sloan Kettering Cancer Center, New York, remarked that there was “no question” that a 10% change in dose would make a difference clinically in thyroid cancer patients, who take levothyroxine under very controlled conditions.

Panelist Arthur Kibbe, Ph.D., of the Nesbit School of Pharmacy, Wilkes University, Wilkes-Barre, Pa., said that if the potency levels of all these products on the market were tightened, the possibility of differences between products would also be lessened and would reduce the chance of adverse effects of switching from one product to another.

Dr. Jurgen Venitz, of the Virginia Commonwealth University School of Pharmacy, Richmond, said that as much as he supported the panel's recommendations, he felt that bioequivalence between products was really the bigger issue. One panelist referred to bioequivalence as “the 800-pound gorilla in the room.”

Speaking for AACE during the open public hearing, Dr. Jeffrey Garber, treasurer and chief of endocrinology at Harvard Vanguard Medical Associates, Boston, said that it has become “increasingly unlikely” that a patient will be given a therapeutically equivalent preparation, and that while the meeting was “a step in the right direction,” it did not address the broader issue of bioequivalence.

Speaking for the Endocrine Society, Dr. Leonard Wartofsky, president of the society, said that current FDA bioequivalence standards are not sensitive enough to detect small but meaningful differences between products, and that the FDA erred in allowing manufacturers to drop the warning that when a product is switched, patients need to call their physician and have their thyroid-stimulating hormone levels measured to retitrate their dose. He referred to a May 2005 meeting cosponsored by the FDA, American Thyroid Association, Endocrine Society, and AACE to review concerns about substitution and bioequivalence, and concerns that one product may be substituted for another—often unbeknownst to the physician—despite differences in potency.

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the targets of a campaign launched by U.S., Mexican, and Canadian government agencies.

In a statement issued Oct. 19, the Food and Drug Administration and the Federal Trade Commission (FTC) announced that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign, the statement says.

On Oct. 19, the FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

“Those of us who care for people with diabetes should be grateful that the FDA and regulators in Canada and Mexico are warning our patients about Web sites offering false hope,” Dr. Philip Levy, chairman of the section of endocrinology and metabolism at Good Samaritan Hospital, Phoenix, said in an interview.

While the Internet can be helpful at times, these particular Web sites are fraudulent and are promoting “cures” for diabetes, with absolutely no evidence to support claims, and could be harmful to patients, he added. Clinicians should encourage patients to report any suspicious Web site to the FDA, and discourage them from trying any of these “cures,” noted Dr. Levy, a past president of the American College of Endocrinology.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Some of the claims on the Web site, according to the letter, include statements that the product lowers blood sugar and cholesterol levels naturally and that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is provided on the FDA's Web site at www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the targets of a campaign launched by U.S., Mexican, and Canadian government agencies.

In a statement issued Oct. 19, the Food and Drug Administration and the Federal Trade Commission (FTC) announced that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign, the statement says.

On Oct. 19, the FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

“Those of us who care for people with diabetes should be grateful that the FDA and regulators in Canada and Mexico are warning our patients about Web sites offering false hope,” Dr. Philip Levy, chairman of the section of endocrinology and metabolism at Good Samaritan Hospital, Phoenix, said in an interview.

While the Internet can be helpful at times, these particular Web sites are fraudulent and are promoting “cures” for diabetes, with absolutely no evidence to support claims, and could be harmful to patients, he added. Clinicians should encourage patients to report any suspicious Web site to the FDA, and discourage them from trying any of these “cures,” noted Dr. Levy, a past president of the American College of Endocrinology.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Some of the claims on the Web site, according to the letter, include statements that the product lowers blood sugar and cholesterol levels naturally and that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is provided on the FDA's Web site at www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

The sale of products that are misrepresented as cures or treatments for diabetes and the Internet sites that advertise these products are the targets of a campaign launched by U.S., Mexican, and Canadian government agencies.

In a statement issued Oct. 19, the Food and Drug Administration and the Federal Trade Commission (FTC) announced that the FDA had issued 24 warning letters to companies marketing dietary supplements with claims that the products treated, cured, prevented, or mitigated diabetes. To date, about 180 letters and other advisories have been sent to online outlets in the three countries as a result of the campaign, the statement says.

On Oct. 19, the FTC also announced a new campaign aimed at educating consumers about how to avoid falling for sham diabetes cures. Included is an example of a Web site promoting a phony product called Glucobate.

“The Internet can be a great source of information, but it also is a billboard for ads that promise miracle cures for diabetes and other serious diseases,” Lynda Parnes, director of the FTC's Bureau of Consumer Protection, said in the statement.

“We will not tolerate practices that raise false hopes and bilk consumers of precious health care dollars,” Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in the statement.

“Those of us who care for people with diabetes should be grateful that the FDA and regulators in Canada and Mexico are warning our patients about Web sites offering false hope,” Dr. Philip Levy, chairman of the section of endocrinology and metabolism at Good Samaritan Hospital, Phoenix, said in an interview.

While the Internet can be helpful at times, these particular Web sites are fraudulent and are promoting “cures” for diabetes, with absolutely no evidence to support claims, and could be harmful to patients, he added. Clinicians should encourage patients to report any suspicious Web site to the FDA, and discourage them from trying any of these “cures,” noted Dr. Levy, a past president of the American College of Endocrinology.

An example of one warning letter, sent by the FDA to a Reno, Nev.-based company about its product called “Enhansulin,” notes that the product is advertised as containing extract from “Caucasian blueberry leaves.” The letter says that marketing this product with the therapeutic claims that appear on its Web site establishes it as a drug and, therefore, violates the Federal Food, Drug, and Cosmetic Act. Some of the claims on the Web site, according to the letter, include statements that the product lowers blood sugar and cholesterol levels naturally and that Caucasian blueberry leaves have been “effectively used to manage the effects of diabetes” for centuries.

The list of the 24 companies that have been sent warning letters, with links to the letters, is provided on the FDA's Web site at www.cfsan.fda.gov/∼dms/dialist.htmlhttp://wemarket4u.net/glucobate/index.html

Several generic versions of the intravenous formulation of the widely used fluoroquinolone ciprofloxacin have been approved by the Food and Drug Administration, as part of what the agency says is its effort to make lower-cost generic drugs more widely available.

The generic formulations are versions of the trade formulation of Cipro IV, approved in 1991 and marketed by Bayer Corp. Ciprofloxacin injection is provided in a concentration of 10 mg/mL, and is packaged in 20-mL and 40-mL vials, and in a 120-mL pharmacy bulk package, according to an Aug. 28 FDA statement announcing the approval.

Drug Topics, an online magazine, listed Cipro IV injection as the top-selling drug in its list of the 200 highest-selling brand name drugs in the United States in 2005, according to the statement. The wholesale acquisition cost of the drugs used in hospitals totaled $115,353,072.

Ciprofloxacin injection is approved for treating infections caused by susceptible strains of designated microorganisms for certain infections in adults, including urinary tract infections, lower respiratory tract infections, nosocomial pneumonia, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, acute sinusitis, and empirical therapy in febrile patients with neutropenia. It is approved for treating complicated UTIs and pyelonephritis due to Escherichia coli, in patients aged 1–17 years, but not as a first choice, according to the Cipro IV label. It is also approved to reduce the incidence of inhalational anthrax after exposure to aerosolized Bacillus anthracis in adult and pediatric patients.

The approval of these generic versions of ciprofloxacin injection “can bring significant savings to the millions of Americans who have certain bacterial infections that can be treated with ciprofloxacin,” Gary J. Buehler, a pharmacist and director of the FDA's Office of Generic Drugs, said in the FDA statement. “These approvals are another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits,” he added.

Other first-time generics approved by the FDA since June include formulations of the nonsteroidal anti-inflammatory drug meloxicam (Mobic), the antidepressant sertraline (Zoloft), and the cholesterol-lowering drug simvastatin (Zocor).

Several generic versions of the intravenous formulation of the widely used fluoroquinolone ciprofloxacin have been approved by the Food and Drug Administration, as part of what the agency says is its effort to make lower-cost generic drugs more widely available.

The generic formulations are versions of the trade formulation of Cipro IV, approved in 1991 and marketed by Bayer Corp. Ciprofloxacin injection is provided in a concentration of 10 mg/mL, and is packaged in 20-mL and 40-mL vials, and in a 120-mL pharmacy bulk package, according to an Aug. 28 FDA statement announcing the approval.

Drug Topics, an online magazine, listed Cipro IV injection as the top-selling drug in its list of the 200 highest-selling brand name drugs in the United States in 2005, according to the statement. The wholesale acquisition cost of the drugs used in hospitals totaled $115,353,072.

Ciprofloxacin injection is approved for treating infections caused by susceptible strains of designated microorganisms for certain infections in adults, including urinary tract infections, lower respiratory tract infections, nosocomial pneumonia, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, acute sinusitis, and empirical therapy in febrile patients with neutropenia. It is approved for treating complicated UTIs and pyelonephritis due to Escherichia coli, in patients aged 1–17 years, but not as a first choice, according to the Cipro IV label. It is also approved to reduce the incidence of inhalational anthrax after exposure to aerosolized Bacillus anthracis in adult and pediatric patients.

The approval of these generic versions of ciprofloxacin injection “can bring significant savings to the millions of Americans who have certain bacterial infections that can be treated with ciprofloxacin,” Gary J. Buehler, a pharmacist and director of the FDA's Office of Generic Drugs, said in the FDA statement. “These approvals are another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits,” he added.

Other first-time generics approved by the FDA since June include formulations of the nonsteroidal anti-inflammatory drug meloxicam (Mobic), the antidepressant sertraline (Zoloft), and the cholesterol-lowering drug simvastatin (Zocor).

Several generic versions of the intravenous formulation of the widely used fluoroquinolone ciprofloxacin have been approved by the Food and Drug Administration, as part of what the agency says is its effort to make lower-cost generic drugs more widely available.

The generic formulations are versions of the trade formulation of Cipro IV, approved in 1991 and marketed by Bayer Corp. Ciprofloxacin injection is provided in a concentration of 10 mg/mL, and is packaged in 20-mL and 40-mL vials, and in a 120-mL pharmacy bulk package, according to an Aug. 28 FDA statement announcing the approval.

Drug Topics, an online magazine, listed Cipro IV injection as the top-selling drug in its list of the 200 highest-selling brand name drugs in the United States in 2005, according to the statement. The wholesale acquisition cost of the drugs used in hospitals totaled $115,353,072.

Ciprofloxacin injection is approved for treating infections caused by susceptible strains of designated microorganisms for certain infections in adults, including urinary tract infections, lower respiratory tract infections, nosocomial pneumonia, bone and joint infections, complicated intraabdominal infections, skin and skin structure infections, acute sinusitis, and empirical therapy in febrile patients with neutropenia. It is approved for treating complicated UTIs and pyelonephritis due to Escherichia coli, in patients aged 1–17 years, but not as a first choice, according to the Cipro IV label. It is also approved to reduce the incidence of inhalational anthrax after exposure to aerosolized Bacillus anthracis in adult and pediatric patients.

The approval of these generic versions of ciprofloxacin injection “can bring significant savings to the millions of Americans who have certain bacterial infections that can be treated with ciprofloxacin,” Gary J. Buehler, a pharmacist and director of the FDA's Office of Generic Drugs, said in the FDA statement. “These approvals are another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits,” he added.

Other first-time generics approved by the FDA since June include formulations of the nonsteroidal anti-inflammatory drug meloxicam (Mobic), the antidepressant sertraline (Zoloft), and the cholesterol-lowering drug simvastatin (Zocor).

GAITHERSBURG, MD. — A federal advisory panel supported the approval of a stainless steel artificial cervical disk for patients with single-level cervical degenerative disk disease, provided that the manufacturer evaluates long-term efficacy and safety in a postmarketing study.

The Food and Drug Administration's Orthopedic and Rehabilitation Devices panel agreed in a 7–0 vote that the Prestige cervical disk, manufactured by Medtronic, was “approvable” but recommended further study. The device is under review for use in skeletally mature patients with cervical degenerative disk disease (DDD) at one level from C3 to C7. DDD is defined as intractable radiculopathy and/or myelopathy that produces symptomatic nerve root or spinal cord compression because of a herniated disk or osteophyte formation.

Panelists agreed that the 2-year study demonstrated the safety and efficacy of the Prestige disk for this indication, but they were concerned about the long term because recipients of the device will have expected life spans of 30–50 years after implantation.

The two-piece device is made of stainless steel, with a metal-on-metal articulation and a ball and trough mechanism, which is affixed to the vertebral body with two bone screws. The device was compared with an anterior plated fusion procedure with structural allograft in a noninferiority, prospective, randomized study of 541 patients (mean age 43–44 years). The patients had single-level cervical DDD, inadequate response to 6 weeks of conservative therapy, signs of progression or spinal cord/nerve root compression, and a neck disability index (NDI) of 30 or greater.

Based on an interim analysis of the data at 24 months after surgery in 250 patients, 80.5% of the Prestige group and 71% of the fusion (control) group met the criteria for overall success (defined as at least a 15-point improvement in the NDI score, neurological maintenance or improvement, no serious adverse event that could be associated with the device, and no second surgery failure), according to Medtronic. Furthermore, the company said, radiographic evaluations indicated that patients' motion was maintained after surgery.

About 80% of patients in both groups experienced adverse events; most occurred perioperatively and resolved over time. The rate of device-related adverse events was 3% in Prestige recipients and nearly 10% in controls, a difference due mostly to cases of pending nonunions. Fewer nonunions and spinal events occurred in the Prestige group, while rates of urogenital adverse events were lower in the fusion group. There were three deaths among fusion patients and none in the Prestige patients.

Mean NDI scores improved by about 80% (15-point improvement) in both groups at 12 and 24 months.

Panelists recommended that the Prestige disk be described as “noninferior” rather than superior to the fusion procedure, because that was what the 2-year study had demonstrated. As another condition for approval, the panel recommended that the company conduct a study in animals to examine the generation and fate of particulate debris from the device, which is a concern associated with metal-on-metal devices.

Medtronic plans to evaluate the same end points, NDI, neurological status, second procedures, and adverse events in patients at 5 years and 7 years after surgery. In response to investigators' suggestions, the device's design has been modified and larger sizes have been added, but these were not studied in the trial, according to the company.

The FDA usually follows the advice of its advisory panels. If approved, the Prestige disk would be the first artifical cervical disk to be marketed in the United States. The agency previously approved two artifical lumbar disks.

GAITHERSBURG, MD. — A federal advisory panel supported the approval of a stainless steel artificial cervical disk for patients with single-level cervical degenerative disk disease, provided that the manufacturer evaluates long-term efficacy and safety in a postmarketing study.

The Food and Drug Administration's Orthopedic and Rehabilitation Devices panel agreed in a 7–0 vote that the Prestige cervical disk, manufactured by Medtronic, was “approvable” but recommended further study. The device is under review for use in skeletally mature patients with cervical degenerative disk disease (DDD) at one level from C3 to C7. DDD is defined as intractable radiculopathy and/or myelopathy that produces symptomatic nerve root or spinal cord compression because of a herniated disk or osteophyte formation.

Panelists agreed that the 2-year study demonstrated the safety and efficacy of the Prestige disk for this indication, but they were concerned about the long term because recipients of the device will have expected life spans of 30–50 years after implantation.

The two-piece device is made of stainless steel, with a metal-on-metal articulation and a ball and trough mechanism, which is affixed to the vertebral body with two bone screws. The device was compared with an anterior plated fusion procedure with structural allograft in a noninferiority, prospective, randomized study of 541 patients (mean age 43–44 years). The patients had single-level cervical DDD, inadequate response to 6 weeks of conservative therapy, signs of progression or spinal cord/nerve root compression, and a neck disability index (NDI) of 30 or greater.

Based on an interim analysis of the data at 24 months after surgery in 250 patients, 80.5% of the Prestige group and 71% of the fusion (control) group met the criteria for overall success (defined as at least a 15-point improvement in the NDI score, neurological maintenance or improvement, no serious adverse event that could be associated with the device, and no second surgery failure), according to Medtronic. Furthermore, the company said, radiographic evaluations indicated that patients' motion was maintained after surgery.

About 80% of patients in both groups experienced adverse events; most occurred perioperatively and resolved over time. The rate of device-related adverse events was 3% in Prestige recipients and nearly 10% in controls, a difference due mostly to cases of pending nonunions. Fewer nonunions and spinal events occurred in the Prestige group, while rates of urogenital adverse events were lower in the fusion group. There were three deaths among fusion patients and none in the Prestige patients.

Mean NDI scores improved by about 80% (15-point improvement) in both groups at 12 and 24 months.

Panelists recommended that the Prestige disk be described as “noninferior” rather than superior to the fusion procedure, because that was what the 2-year study had demonstrated. As another condition for approval, the panel recommended that the company conduct a study in animals to examine the generation and fate of particulate debris from the device, which is a concern associated with metal-on-metal devices.

Medtronic plans to evaluate the same end points, NDI, neurological status, second procedures, and adverse events in patients at 5 years and 7 years after surgery. In response to investigators' suggestions, the device's design has been modified and larger sizes have been added, but these were not studied in the trial, according to the company.

The FDA usually follows the advice of its advisory panels. If approved, the Prestige disk would be the first artifical cervical disk to be marketed in the United States. The agency previously approved two artifical lumbar disks.

GAITHERSBURG, MD. — A federal advisory panel supported the approval of a stainless steel artificial cervical disk for patients with single-level cervical degenerative disk disease, provided that the manufacturer evaluates long-term efficacy and safety in a postmarketing study.

The Food and Drug Administration's Orthopedic and Rehabilitation Devices panel agreed in a 7–0 vote that the Prestige cervical disk, manufactured by Medtronic, was “approvable” but recommended further study. The device is under review for use in skeletally mature patients with cervical degenerative disk disease (DDD) at one level from C3 to C7. DDD is defined as intractable radiculopathy and/or myelopathy that produces symptomatic nerve root or spinal cord compression because of a herniated disk or osteophyte formation.

Panelists agreed that the 2-year study demonstrated the safety and efficacy of the Prestige disk for this indication, but they were concerned about the long term because recipients of the device will have expected life spans of 30–50 years after implantation.

The two-piece device is made of stainless steel, with a metal-on-metal articulation and a ball and trough mechanism, which is affixed to the vertebral body with two bone screws. The device was compared with an anterior plated fusion procedure with structural allograft in a noninferiority, prospective, randomized study of 541 patients (mean age 43–44 years). The patients had single-level cervical DDD, inadequate response to 6 weeks of conservative therapy, signs of progression or spinal cord/nerve root compression, and a neck disability index (NDI) of 30 or greater.

Based on an interim analysis of the data at 24 months after surgery in 250 patients, 80.5% of the Prestige group and 71% of the fusion (control) group met the criteria for overall success (defined as at least a 15-point improvement in the NDI score, neurological maintenance or improvement, no serious adverse event that could be associated with the device, and no second surgery failure), according to Medtronic. Furthermore, the company said, radiographic evaluations indicated that patients' motion was maintained after surgery.

About 80% of patients in both groups experienced adverse events; most occurred perioperatively and resolved over time. The rate of device-related adverse events was 3% in Prestige recipients and nearly 10% in controls, a difference due mostly to cases of pending nonunions. Fewer nonunions and spinal events occurred in the Prestige group, while rates of urogenital adverse events were lower in the fusion group. There were three deaths among fusion patients and none in the Prestige patients.

Mean NDI scores improved by about 80% (15-point improvement) in both groups at 12 and 24 months.

Panelists recommended that the Prestige disk be described as “noninferior” rather than superior to the fusion procedure, because that was what the 2-year study had demonstrated. As another condition for approval, the panel recommended that the company conduct a study in animals to examine the generation and fate of particulate debris from the device, which is a concern associated with metal-on-metal devices.

Medtronic plans to evaluate the same end points, NDI, neurological status, second procedures, and adverse events in patients at 5 years and 7 years after surgery. In response to investigators' suggestions, the device's design has been modified and larger sizes have been added, but these were not studied in the trial, according to the company.

The FDA usually follows the advice of its advisory panels. If approved, the Prestige disk would be the first artifical cervical disk to be marketed in the United States. The agency previously approved two artifical lumbar disks.

A patient-activated transdermal product for short-term management of acute postoperative pain in adults requiring opioid analgesia has received Food and Drug Administration approval.

The fentanyl iontophoretic transdermal system, marketed under the trade name IONSYS by Alza Corp., was approved for use only in hospitalized patients.

In an interview, Dr. Eugene R. Viscusi, director of regional anesthesia and acute pain management, Thomas Jefferson University, Philadelphia, described IONSYS as a compact, preprogrammed, needle-free system that provides an alternative to administering morphine via intravenous patient-controlled analgesia (PCA). Each unit is about 2 by 3 inches, with adhesive backing and a dosing button. The patient double clicks the button when analgesia is needed, and 40 mcg of fentanyl is delivered over 10 minutes.

The approval of IONSYS and of DepoDur, a sustained-release injectable morphine for epidural use approved in 2004, illustrate the movement of postoperative analgesia “into this realm of less invasive and less burdensome technologies” that are more user friendly and less cumbersome for patients and nursing staff, Dr. Viscusi noted. He has served as a scientific adviser to Alza, which has provided research support to Thomas Jefferson University.

IONSYS is applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm, and is replaced every 24 hours or when 80 doses have been administered. A maximum of 6 doses per hour and 80 doses over 24 hours can be administered; no more than 1 dose every 10 minutes can be released. Patients should be titrated to comfort before starting treatment, the label says.

IONSYS was compared with placebo or IV PCA morphine in seven studies of 3,392 patients (2,114 using IONSYS) aged 18–90 years, with body types ranging from very thin to obese. In those studies, IONSYS provided effective acute pain management after a variety of surgical procedures, including orthopedic, general, and gynecologic surgery, according to Dr. Viscusi. The most common adverse effects included nausea, vomiting, application site-related erythema, fever, and headache.

Dr. Viscusi was the lead author of a study in which more than 600 postoperative adult patients were randomly assigned to either IONSYS or IV PCA. The patients rated the two approaches “as basically therapeutically equivalent” in terms of pain control after 24 hours of treatment, he said. Opioid-related side effects were comparable in the study (JAMA 2004;291:1333–41).

Fentanyl is a schedule II drug with a high potential for abuse.

The fentanyl iontophoretic transdermal system device (IONSYS) is a preprogrammed, needle-free system. Ortho-McNeil, Inc.

A patient-activated transdermal product for short-term management of acute postoperative pain in adults requiring opioid analgesia has received Food and Drug Administration approval.

The fentanyl iontophoretic transdermal system, marketed under the trade name IONSYS by Alza Corp., was approved for use only in hospitalized patients.

In an interview, Dr. Eugene R. Viscusi, director of regional anesthesia and acute pain management, Thomas Jefferson University, Philadelphia, described IONSYS as a compact, preprogrammed, needle-free system that provides an alternative to administering morphine via intravenous patient-controlled analgesia (PCA). Each unit is about 2 by 3 inches, with adhesive backing and a dosing button. The patient double clicks the button when analgesia is needed, and 40 mcg of fentanyl is delivered over 10 minutes.

The approval of IONSYS and of DepoDur, a sustained-release injectable morphine for epidural use approved in 2004, illustrate the movement of postoperative analgesia “into this realm of less invasive and less burdensome technologies” that are more user friendly and less cumbersome for patients and nursing staff, Dr. Viscusi noted. He has served as a scientific adviser to Alza, which has provided research support to Thomas Jefferson University.

IONSYS is applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm, and is replaced every 24 hours or when 80 doses have been administered. A maximum of 6 doses per hour and 80 doses over 24 hours can be administered; no more than 1 dose every 10 minutes can be released. Patients should be titrated to comfort before starting treatment, the label says.

IONSYS was compared with placebo or IV PCA morphine in seven studies of 3,392 patients (2,114 using IONSYS) aged 18–90 years, with body types ranging from very thin to obese. In those studies, IONSYS provided effective acute pain management after a variety of surgical procedures, including orthopedic, general, and gynecologic surgery, according to Dr. Viscusi. The most common adverse effects included nausea, vomiting, application site-related erythema, fever, and headache.

Dr. Viscusi was the lead author of a study in which more than 600 postoperative adult patients were randomly assigned to either IONSYS or IV PCA. The patients rated the two approaches “as basically therapeutically equivalent” in terms of pain control after 24 hours of treatment, he said. Opioid-related side effects were comparable in the study (JAMA 2004;291:1333–41).

Fentanyl is a schedule II drug with a high potential for abuse.

The fentanyl iontophoretic transdermal system device (IONSYS) is a preprogrammed, needle-free system. Ortho-McNeil, Inc.

A patient-activated transdermal product for short-term management of acute postoperative pain in adults requiring opioid analgesia has received Food and Drug Administration approval.

The fentanyl iontophoretic transdermal system, marketed under the trade name IONSYS by Alza Corp., was approved for use only in hospitalized patients.

In an interview, Dr. Eugene R. Viscusi, director of regional anesthesia and acute pain management, Thomas Jefferson University, Philadelphia, described IONSYS as a compact, preprogrammed, needle-free system that provides an alternative to administering morphine via intravenous patient-controlled analgesia (PCA). Each unit is about 2 by 3 inches, with adhesive backing and a dosing button. The patient double clicks the button when analgesia is needed, and 40 mcg of fentanyl is delivered over 10 minutes.

The approval of IONSYS and of DepoDur, a sustained-release injectable morphine for epidural use approved in 2004, illustrate the movement of postoperative analgesia “into this realm of less invasive and less burdensome technologies” that are more user friendly and less cumbersome for patients and nursing staff, Dr. Viscusi noted. He has served as a scientific adviser to Alza, which has provided research support to Thomas Jefferson University.

IONSYS is applied to intact, nonirritated, nonirradiated skin on the chest or upper outer arm, and is replaced every 24 hours or when 80 doses have been administered. A maximum of 6 doses per hour and 80 doses over 24 hours can be administered; no more than 1 dose every 10 minutes can be released. Patients should be titrated to comfort before starting treatment, the label says.

IONSYS was compared with placebo or IV PCA morphine in seven studies of 3,392 patients (2,114 using IONSYS) aged 18–90 years, with body types ranging from very thin to obese. In those studies, IONSYS provided effective acute pain management after a variety of surgical procedures, including orthopedic, general, and gynecologic surgery, according to Dr. Viscusi. The most common adverse effects included nausea, vomiting, application site-related erythema, fever, and headache.

Dr. Viscusi was the lead author of a study in which more than 600 postoperative adult patients were randomly assigned to either IONSYS or IV PCA. The patients rated the two approaches “as basically therapeutically equivalent” in terms of pain control after 24 hours of treatment, he said. Opioid-related side effects were comparable in the study (JAMA 2004;291:1333–41).

Fentanyl is a schedule II drug with a high potential for abuse.

The fentanyl iontophoretic transdermal system device (IONSYS) is a preprogrammed, needle-free system. Ortho-McNeil, Inc.

Consumers should not buy or use prescription drugs obtained from certain Canadian Web sites allegedly selling counterfeit versions of Lipitor, Propecia, a breast cancer drug, and other prescription drugs, according to a warning issued by the Food and Drug Administration.

In a statement, the FDA said that consumers should not use Web sites that have orders filled by the Mediplan Prescription Plus pharmacy or Mediplan Global Health in Manitoba, Canada, because of reports that these companies are selling counterfeit versions of prescription drugs to U.S. consumers. These reports are being investigated by the FDA, which is working with international law enforcement authorities.

Preliminary results of laboratory analyses for products from these companies intercepted on their way to the United States have identified counterfeit versions of the following prescription drugs: the cholesterol-lowering agents Lipitor (atorvastatin), Crestor (rosuvastatin), and Zetia (ezetimibe); the antihypertensives Diovan (valsartan) and Hyzaar (losartan-hydrochlorothiazide); Actonel (risedronate), a bisphosphonate for osteoporosis; Nexium (esomeprazole) for gastroesophageal reflux disease; Celebrex (celecoxib) for arthritis-related pain; Arimidex (anastrozole) for breast cancer; and Propecia (finasteride), for male pattern baldness.

The statement also cited an August 2005 investigation that revealed that some Internet sites claiming to be Canadian were not based in Canada and were selling drugs of “dubious” safety and efficacy. The investigation, conducted at New York, Miami, and Los Angeles airports, found that that 85% of the drugs promoted as coming from a Canadian pharmacy were from 27 other countries and included counterfeit products.

Consumers should not buy or use prescription drugs obtained from certain Canadian Web sites allegedly selling counterfeit versions of Lipitor, Propecia, a breast cancer drug, and other prescription drugs, according to a warning issued by the Food and Drug Administration.

In a statement, the FDA said that consumers should not use Web sites that have orders filled by the Mediplan Prescription Plus pharmacy or Mediplan Global Health in Manitoba, Canada, because of reports that these companies are selling counterfeit versions of prescription drugs to U.S. consumers. These reports are being investigated by the FDA, which is working with international law enforcement authorities.

Preliminary results of laboratory analyses for products from these companies intercepted on their way to the United States have identified counterfeit versions of the following prescription drugs: the cholesterol-lowering agents Lipitor (atorvastatin), Crestor (rosuvastatin), and Zetia (ezetimibe); the antihypertensives Diovan (valsartan) and Hyzaar (losartan-hydrochlorothiazide); Actonel (risedronate), a bisphosphonate for osteoporosis; Nexium (esomeprazole) for gastroesophageal reflux disease; Celebrex (celecoxib) for arthritis-related pain; Arimidex (anastrozole) for breast cancer; and Propecia (finasteride), for male pattern baldness.

The statement also cited an August 2005 investigation that revealed that some Internet sites claiming to be Canadian were not based in Canada and were selling drugs of “dubious” safety and efficacy. The investigation, conducted at New York, Miami, and Los Angeles airports, found that that 85% of the drugs promoted as coming from a Canadian pharmacy were from 27 other countries and included counterfeit products.

Consumers should not buy or use prescription drugs obtained from certain Canadian Web sites allegedly selling counterfeit versions of Lipitor, Propecia, a breast cancer drug, and other prescription drugs, according to a warning issued by the Food and Drug Administration.

In a statement, the FDA said that consumers should not use Web sites that have orders filled by the Mediplan Prescription Plus pharmacy or Mediplan Global Health in Manitoba, Canada, because of reports that these companies are selling counterfeit versions of prescription drugs to U.S. consumers. These reports are being investigated by the FDA, which is working with international law enforcement authorities.

Preliminary results of laboratory analyses for products from these companies intercepted on their way to the United States have identified counterfeit versions of the following prescription drugs: the cholesterol-lowering agents Lipitor (atorvastatin), Crestor (rosuvastatin), and Zetia (ezetimibe); the antihypertensives Diovan (valsartan) and Hyzaar (losartan-hydrochlorothiazide); Actonel (risedronate), a bisphosphonate for osteoporosis; Nexium (esomeprazole) for gastroesophageal reflux disease; Celebrex (celecoxib) for arthritis-related pain; Arimidex (anastrozole) for breast cancer; and Propecia (finasteride), for male pattern baldness.

The statement also cited an August 2005 investigation that revealed that some Internet sites claiming to be Canadian were not based in Canada and were selling drugs of “dubious” safety and efficacy. The investigation, conducted at New York, Miami, and Los Angeles airports, found that that 85% of the drugs promoted as coming from a Canadian pharmacy were from 27 other countries and included counterfeit products.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended against approving the fluoroquinolone gemifloxacin for treating acute bacterial sinusitis, because of the noninferiority design of the studies submitted for approval and concerns about the increased rate of rashes associated with the drug in clinical trials and since approval.

At a meeting in September, the FDA's Anti-Infective Drugs Advisory Committee voted 11 to 2 that the safety and effectiveness data presented did not demonstrate an acceptable risk-benefit profile of a 5-day course of gemifloxacin for treating acute bacterial sinusitis (ABS). Panelists recommended that effectiveness should be shown in a placebo-controlled superiority trial; several panelists thought the drug had potential as a second-line treatment for ABS and also recommended studying gemifloxacin for ABS treatment failures. The FDA usually follows the advice of its advisory panels.

Two panelists said that based on the previous standard of noninferiority studies, they believed the drug had been shown to be effective, but they voted no because placebo-controlled trials are now considered the standard for approval. Among the panel's concerns about rashes were that the appearance of a rash would lead to testing and treatment, and that patients would be labeled as “quinolone sensitive” and would no longer be considered for quinolone treatment.

Gemifloxacin, an oral broad-spectrum fluoroquinolone marketed as Factive by Oscient Pharmaceuticals, was approved in 2003 for treating mild to moderate community-acquired pneumonia (CAP) due to Streptococcus pneumoniae (including multidrug-resistant strains), Hemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Klebsiella pneumoniae and for treating acute bacterial exacerbations of chronic bronchitis (ABECB) due to S. pneumoniae, H. influenzae, Hemophilus parainfluenzae, and M. catarrhalis. A 7-day dosing regimen is approved for CAP; a 5-day regimen is approved for the bronchitis indication.

At that time, the FDA did not approve gemifloxacin for ABS, concluding that the benefits did not outweigh the risk of adverse events because of concerns that included the higher rate of cutaneous reactions and because there was no unmet need for treating ABS. Since then, the drug has been prescribed off-label for ABS.

In another attempt to get gemifloxacin approved for ABS, Oscient provided the four clinical studies of more than 6,500 patients submitted to the FDA previously, new studies of more than 1,000 patients, and postmarketing safety data collected since the drug was approved. The indication under FDA review was for treating ABS due to S. pneumoniae, H. influenzae, M. catarrhalis, Staphylococcus aureus (methicillin-susceptible strains only), K. pneumoniae, and Escherichia coli at a dose of 320 mg once a day for 5 days.

During the advisory panel vote, Dr. Donald M. Poretz, who is in private practice in Annandale, Va., pointed out that antibiotics are overused, sinusitis is overdiagnosed, and plenty of drugs are available to treat bacterial sinusitis. “I'm not sure this would add anything to our armamentarium other than a greater rate of rash,” he said, noting that some people who develop rashes on gemifloxacin would be labeled as allergic to all quinolones and would have no access to a quinolone when they needed it.

Dr. Richard Frothingham of the infectious diseases department at Duke University, voted in favor of approval and said he believed that gemifloxacin had been shown to be effective for ABS. He backed approval with the condition that the package insert include more information about the associated rashes. Even if the drug is not approved for ABS, this label—and company detailing to physicians—should clearly indicate that rashes are far more common with gemifloxacin than with comparators, he added, noting that rash is not even listed in the current label.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended against approving the fluoroquinolone gemifloxacin for treating acute bacterial sinusitis, because of the noninferiority design of the studies submitted for approval and concerns about the increased rate of rashes associated with the drug in clinical trials and since approval.

At a meeting in September, the FDA's Anti-Infective Drugs Advisory Committee voted 11 to 2 that the safety and effectiveness data presented did not demonstrate an acceptable risk-benefit profile of a 5-day course of gemifloxacin for treating acute bacterial sinusitis (ABS). Panelists recommended that effectiveness should be shown in a placebo-controlled superiority trial; several panelists thought the drug had potential as a second-line treatment for ABS and also recommended studying gemifloxacin for ABS treatment failures. The FDA usually follows the advice of its advisory panels.

Two panelists said that based on the previous standard of noninferiority studies, they believed the drug had been shown to be effective, but they voted no because placebo-controlled trials are now considered the standard for approval. Among the panel's concerns about rashes were that the appearance of a rash would lead to testing and treatment, and that patients would be labeled as “quinolone sensitive” and would no longer be considered for quinolone treatment.

Gemifloxacin, an oral broad-spectrum fluoroquinolone marketed as Factive by Oscient Pharmaceuticals, was approved in 2003 for treating mild to moderate community-acquired pneumonia (CAP) due to Streptococcus pneumoniae (including multidrug-resistant strains), Hemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Klebsiella pneumoniae and for treating acute bacterial exacerbations of chronic bronchitis (ABECB) due to S. pneumoniae, H. influenzae, Hemophilus parainfluenzae, and M. catarrhalis. A 7-day dosing regimen is approved for CAP; a 5-day regimen is approved for the bronchitis indication.

At that time, the FDA did not approve gemifloxacin for ABS, concluding that the benefits did not outweigh the risk of adverse events because of concerns that included the higher rate of cutaneous reactions and because there was no unmet need for treating ABS. Since then, the drug has been prescribed off-label for ABS.

In another attempt to get gemifloxacin approved for ABS, Oscient provided the four clinical studies of more than 6,500 patients submitted to the FDA previously, new studies of more than 1,000 patients, and postmarketing safety data collected since the drug was approved. The indication under FDA review was for treating ABS due to S. pneumoniae, H. influenzae, M. catarrhalis, Staphylococcus aureus (methicillin-susceptible strains only), K. pneumoniae, and Escherichia coli at a dose of 320 mg once a day for 5 days.

During the advisory panel vote, Dr. Donald M. Poretz, who is in private practice in Annandale, Va., pointed out that antibiotics are overused, sinusitis is overdiagnosed, and plenty of drugs are available to treat bacterial sinusitis. “I'm not sure this would add anything to our armamentarium other than a greater rate of rash,” he said, noting that some people who develop rashes on gemifloxacin would be labeled as allergic to all quinolones and would have no access to a quinolone when they needed it.

Dr. Richard Frothingham of the infectious diseases department at Duke University, voted in favor of approval and said he believed that gemifloxacin had been shown to be effective for ABS. He backed approval with the condition that the package insert include more information about the associated rashes. Even if the drug is not approved for ABS, this label—and company detailing to physicians—should clearly indicate that rashes are far more common with gemifloxacin than with comparators, he added, noting that rash is not even listed in the current label.

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel has recommended against approving the fluoroquinolone gemifloxacin for treating acute bacterial sinusitis, because of the noninferiority design of the studies submitted for approval and concerns about the increased rate of rashes associated with the drug in clinical trials and since approval.

At a meeting in September, the FDA's Anti-Infective Drugs Advisory Committee voted 11 to 2 that the safety and effectiveness data presented did not demonstrate an acceptable risk-benefit profile of a 5-day course of gemifloxacin for treating acute bacterial sinusitis (ABS). Panelists recommended that effectiveness should be shown in a placebo-controlled superiority trial; several panelists thought the drug had potential as a second-line treatment for ABS and also recommended studying gemifloxacin for ABS treatment failures. The FDA usually follows the advice of its advisory panels.

Two panelists said that based on the previous standard of noninferiority studies, they believed the drug had been shown to be effective, but they voted no because placebo-controlled trials are now considered the standard for approval. Among the panel's concerns about rashes were that the appearance of a rash would lead to testing and treatment, and that patients would be labeled as “quinolone sensitive” and would no longer be considered for quinolone treatment.

Gemifloxacin, an oral broad-spectrum fluoroquinolone marketed as Factive by Oscient Pharmaceuticals, was approved in 2003 for treating mild to moderate community-acquired pneumonia (CAP) due to Streptococcus pneumoniae (including multidrug-resistant strains), Hemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Klebsiella pneumoniae and for treating acute bacterial exacerbations of chronic bronchitis (ABECB) due to S. pneumoniae, H. influenzae, Hemophilus parainfluenzae, and M. catarrhalis. A 7-day dosing regimen is approved for CAP; a 5-day regimen is approved for the bronchitis indication.

At that time, the FDA did not approve gemifloxacin for ABS, concluding that the benefits did not outweigh the risk of adverse events because of concerns that included the higher rate of cutaneous reactions and because there was no unmet need for treating ABS. Since then, the drug has been prescribed off-label for ABS.

In another attempt to get gemifloxacin approved for ABS, Oscient provided the four clinical studies of more than 6,500 patients submitted to the FDA previously, new studies of more than 1,000 patients, and postmarketing safety data collected since the drug was approved. The indication under FDA review was for treating ABS due to S. pneumoniae, H. influenzae, M. catarrhalis, Staphylococcus aureus (methicillin-susceptible strains only), K. pneumoniae, and Escherichia coli at a dose of 320 mg once a day for 5 days.

During the advisory panel vote, Dr. Donald M. Poretz, who is in private practice in Annandale, Va., pointed out that antibiotics are overused, sinusitis is overdiagnosed, and plenty of drugs are available to treat bacterial sinusitis. “I'm not sure this would add anything to our armamentarium other than a greater rate of rash,” he said, noting that some people who develop rashes on gemifloxacin would be labeled as allergic to all quinolones and would have no access to a quinolone when they needed it.

Dr. Richard Frothingham of the infectious diseases department at Duke University, voted in favor of approval and said he believed that gemifloxacin had been shown to be effective for ABS. He backed approval with the condition that the package insert include more information about the associated rashes. Even if the drug is not approved for ABS, this label—and company detailing to physicians—should clearly indicate that rashes are far more common with gemifloxacin than with comparators, he added, noting that rash is not even listed in the current label.

A temporary shortage in the supply of Adacel—the tetanus-diphtheria-pertussis vaccine marketed by Sanofi-Pasteur—is expected to last until the end of the year.

Boostrix, the Tdap booster vaccine manufactured by GlaxoSmithKline, is in good supply, according to the Centers for Disease Control and Prevention. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) is indicated as a booster for adolescents and adults aged 11–64 years, while Boostrix is indicated for adolescents aged 10–18 years. For information about Adacel availability, call Sanofi-Pasteur at 800-VACCINE.

The supply shortage of Adacel is expected to be resolved by the end of 2006, said Susan Watkins, a spokesperson for Sanofi-Pasteur.

A new vaccine production facility in Toronto that will provide a sevenfold increase of the supply of vaccines with pertussis components was approved by the Food and Drug Administration in late August.

That facility has already started to manufacture the DTaP vaccine Daptacel, and will begin producing Adacel next, Ms. Watkins said in an interview.

In the meantime, Adacel is being manufactured in another facility, but not in large enough quantities to meet the demand, she added.

Updates on the Adacel shortage will be provided on the CDC Web site at www.cdc.gov/nip/news/shortages/default.htm

A temporary shortage in the supply of Adacel—the tetanus-diphtheria-pertussis vaccine marketed by Sanofi-Pasteur—is expected to last until the end of the year.

Boostrix, the Tdap booster vaccine manufactured by GlaxoSmithKline, is in good supply, according to the Centers for Disease Control and Prevention. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) is indicated as a booster for adolescents and adults aged 11–64 years, while Boostrix is indicated for adolescents aged 10–18 years. For information about Adacel availability, call Sanofi-Pasteur at 800-VACCINE.

The supply shortage of Adacel is expected to be resolved by the end of 2006, said Susan Watkins, a spokesperson for Sanofi-Pasteur.

A new vaccine production facility in Toronto that will provide a sevenfold increase of the supply of vaccines with pertussis components was approved by the Food and Drug Administration in late August.

That facility has already started to manufacture the DTaP vaccine Daptacel, and will begin producing Adacel next, Ms. Watkins said in an interview.

In the meantime, Adacel is being manufactured in another facility, but not in large enough quantities to meet the demand, she added.

Updates on the Adacel shortage will be provided on the CDC Web site at www.cdc.gov/nip/news/shortages/default.htm

A temporary shortage in the supply of Adacel—the tetanus-diphtheria-pertussis vaccine marketed by Sanofi-Pasteur—is expected to last until the end of the year.

Boostrix, the Tdap booster vaccine manufactured by GlaxoSmithKline, is in good supply, according to the Centers for Disease Control and Prevention. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) is indicated as a booster for adolescents and adults aged 11–64 years, while Boostrix is indicated for adolescents aged 10–18 years. For information about Adacel availability, call Sanofi-Pasteur at 800-VACCINE.

The supply shortage of Adacel is expected to be resolved by the end of 2006, said Susan Watkins, a spokesperson for Sanofi-Pasteur.

A new vaccine production facility in Toronto that will provide a sevenfold increase of the supply of vaccines with pertussis components was approved by the Food and Drug Administration in late August.

That facility has already started to manufacture the DTaP vaccine Daptacel, and will begin producing Adacel next, Ms. Watkins said in an interview.

In the meantime, Adacel is being manufactured in another facility, but not in large enough quantities to meet the demand, she added.

Updates on the Adacel shortage will be provided on the CDC Web site at www.cdc.gov/nip/news/shortages/default.htm