Alicia Ault

WASHINGTON — The nonprofit Consumers Union has issued the first several of what is slated to be a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (http://www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24-$30 per month, depending on dosage, and generic aspirin at a cost of $24-$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

The Drug Effectiveness Review Project plans 25 reports in all, and will update its reports every 6 months. The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first several of what is slated to be a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (http://www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24-$30 per month, depending on dosage, and generic aspirin at a cost of $24-$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

The Drug Effectiveness Review Project plans 25 reports in all, and will update its reports every 6 months. The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

WASHINGTON — The nonprofit Consumers Union has issued the first several of what is slated to be a series of evidence-based, patient-friendly reports listing what it calls the most cost-effective drugs, organization officials announced at a press conference.

The initial guides cover nonsteroidal anti-inflammatory agents (NSAIDs), statins, and proton pump inhibitors (PPIs).

The publisher of Consumer Reports said it hopes that patients—especially those with little or no drug benefit coverage—will use these reports to make informed choices in conjunction with their physicians.

The reports are designed to cut through the clutter of drug company advertising and scattered Internet searches. But drug makers won't be allowed to use the “Best Buy Drugs” designation in marketing or ads: Consumers Union prohibits manufacturers from commercializing any of its recommendations.

The guides should be familiar to anyone who has used Consumer Reports' ratings to buy a car, appliance, or bicycle. But unlike the group's analyses on other consumer goods, the Best Buy Drugs reports are free of charge.

“In each category, based on all the evidence, we've identified Best Buy Drugs—the drugs that are likely to be the best, most affordable choices for most people,” said Joel Gurin, executive vice president of Consumers Union.

The Best Buy Drugs are not selected based on Consumers Union's own tests, however, but rather on systematic reviews conducted by the Drug Effectiveness Review Project (DERP), and on further peer review from medical experts like Mark Helfand, M.D., director of the Oregon evidence-based practice center at Oregon Health and Science University, Portland, which initiated DERP in 2003.

DERP follows the literature review and analysis methods pioneered by the Cochrane Collaboration. That lends the Consumers Union's reports credibility, said Peter Toth, M.D., director of cardiovascular disease prevention at Sterling Rock Falls Clinic in Sterling, Ill.

“I believe patients will find it to be a valuable resource when trying to balance cost with clinical efficacy,” Dr. Toth said.

Funded by 12 states, DERP has completed reports on 12 therapeutic categories. Consumers Union is making the first three available on a new Web site (http://www.CRBestBuyDrugs.org

The organization has said that it will add three more categories over the next few months—selective serotonin reuptake inhibitors, β-blockers, and ACE inhibitors—and will continue to do so on a monthly basis.

Each report, which is also available in print form, offers a chart comparing the average monthly price for every drug—brand-name, generic, and over-the-counter—available in the class, at each dosage.

Price data are purchased from NDCHealth, a company that processes pharmacy transactions, and those data reflect national retail averages. Consumers may be able to find even better prices by shopping around, said Gail Shearer, director of health policy analysis for Consumers Union.

In the statin category, the report recommends generic lovastatin as its Best Buy Drug for reducing low-density lipoprotein (LDL) by less than 40%. Lovastatin costs an average $28 per month for 10 mg and $40 for 20 mg, according to Consumers Union. Lipitor (atorvastatin), at an average $117 per month, is the Best Buy Drug for LDL reduction of more than 40%.

Although Crestor (rosuvastatin) offers better LDL reduction for the price, it is not recommended because it has not been proved to reduce heart attacks or death, and safety studies are still being conducted, the report said.

Consumers Union rates the over-the-counter version of Prilosec (omeprazole) as the Best Buy Drug among the proton pump inhibitors. The 20 mg/day dosage costs $24 a month—one-fifth the cost of the next least-expensive drug in the class. And, it “is just as likely to relieve symptoms for most people with GERD [gastroesophageal reflux disease],” the report said. But the report also counsels people with drug coverage to talk with their physician about which medication has the lowest out-of-pocket cost under the patient's plan.

Dr. Toth said that if patients use an over-the-counter drug to treat GERD, they might skip seeing a physician—a potentially troubling issue.

“In the case of PPIs, there is concern because among a significant percentage of patients who suffer from chronic GERD, you do have to make sure that they're not developing Barrett's esophagus and that they don't have something more significant than simple reflux,” he said.

Consumers Union reviewers were initially worried about self-medication, but added a caveat to increase the dose or see a physician if symptoms did not improve, said Steve Findlay, a health care analyst with Consumers Union.

Reviewers were more concerned about highlighting over-the-counter medications in the NSAID category because of those drugs' potential to cause ulcers with chronic use, he said. The Best Buy Drugs in that category were generic ibuprofen at an average cost of $24-$30 per month, depending on dosage, and generic aspirin at a cost of $24-$32 a month. By taking these older, generic medicines, patients could save up to $2,160 a year, Consumers Union said.

Patients without drug coverage could consider over-the-counter NSAIDs, but only for periodic—not chronic—use, the report said. The evidence shows that the COX-2 inhibitors Celebrex (celecoxib) and Bextra (valdexocib) may cause fewer stomach ulcers, but it's not clear yet whether they lower the risk of dangerous ulcers or serious gastrointestinal bleeding, and physicians may be more cautious about prescribing these therapies in the wake of Vioxx's recall, the report said.

The Drug Effectiveness Review Project plans 25 reports in all, and will update its reports every 6 months. The Best Buy Drugs project is funded partly by grants from the Engelberg Foundation, and from the National Library of Medicine.

The Food and Drug Administration has approved a prescription formulation of omega-3 fatty acids that offers patients at risk for heart disease a simpler way to ensure they are getting enough of the substance.

The drug, Omacor, was approved in November as an adjunct to diet to help reduce triglycerides in patients with levels of more than 500 mg/dL. Each 1-g capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids, primarily eicosa-pentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), according to the drug's label.

That makes it much more potent than most of the over-the-counter fish oil supplements, and because it is produced according to FDA's good manufacturing practice standards, Omacor may be of higher quality than OTC supplements, said William Harris, Ph.D., director of lipid research at the Mid America Heart Institute in Kansas City, Mo.

“I think Omacor really is an advance in omega-3s,” said Dr. Harris, coauthor of the American Heart Association Nutrition Committee's recommendations on fish oil and an investigator in the FDA approval trial for Pronova Biocare AS, a Norwegian company that developed Omacor. In that study, 84 patients with severe hypertriglyceridemia (with an average 900 mg/dL) were randomized to placebo or Omacor. Patients taking Omacor had a 45% drop in triglyceride levels. Dr. Harris has received no other financial support from the company.

The AHA recommended in 2002 that patients with documented coronary heart disease should consume at least 1 gram of omega-3 fatty acids daily. Ideally, the omega-3s should come from fatty fish, but the AHA said that patients could take supplements.

To lower triglycerides, patients need to consume at least 2–4 g of omega-3 fatty acids daily, according to the guidelines. Omacor or OTC fish oil should be used in conjunction with niacin or fibrate therapies, Dr. Harris added.

The label recommends that patients taking Omacor have their triglyceride levels closely monitored, and that if they don't respond within 2 months, the drug should be stopped. Patients taking anticoagulants should also be monitored, as there have been some reports of prolonged bleeding with omega-3s.

Reliant Pharmaceuticals Inc. will market Omacor in the United States.

The Food and Drug Administration has approved a prescription formulation of omega-3 fatty acids that offers patients at risk for heart disease a simpler way to ensure they are getting enough of the substance.

The drug, Omacor, was approved in November as an adjunct to diet to help reduce triglycerides in patients with levels of more than 500 mg/dL. Each 1-g capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids, primarily eicosa-pentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), according to the drug's label.

That makes it much more potent than most of the over-the-counter fish oil supplements, and because it is produced according to FDA's good manufacturing practice standards, Omacor may be of higher quality than OTC supplements, said William Harris, Ph.D., director of lipid research at the Mid America Heart Institute in Kansas City, Mo.

“I think Omacor really is an advance in omega-3s,” said Dr. Harris, coauthor of the American Heart Association Nutrition Committee's recommendations on fish oil and an investigator in the FDA approval trial for Pronova Biocare AS, a Norwegian company that developed Omacor. In that study, 84 patients with severe hypertriglyceridemia (with an average 900 mg/dL) were randomized to placebo or Omacor. Patients taking Omacor had a 45% drop in triglyceride levels. Dr. Harris has received no other financial support from the company.

The AHA recommended in 2002 that patients with documented coronary heart disease should consume at least 1 gram of omega-3 fatty acids daily. Ideally, the omega-3s should come from fatty fish, but the AHA said that patients could take supplements.

To lower triglycerides, patients need to consume at least 2–4 g of omega-3 fatty acids daily, according to the guidelines. Omacor or OTC fish oil should be used in conjunction with niacin or fibrate therapies, Dr. Harris added.

The label recommends that patients taking Omacor have their triglyceride levels closely monitored, and that if they don't respond within 2 months, the drug should be stopped. Patients taking anticoagulants should also be monitored, as there have been some reports of prolonged bleeding with omega-3s.

Reliant Pharmaceuticals Inc. will market Omacor in the United States.

The Food and Drug Administration has approved a prescription formulation of omega-3 fatty acids that offers patients at risk for heart disease a simpler way to ensure they are getting enough of the substance.

The drug, Omacor, was approved in November as an adjunct to diet to help reduce triglycerides in patients with levels of more than 500 mg/dL. Each 1-g capsule contains at least 900 mg of the ethyl esters of omega-3 fatty acids, primarily eicosa-pentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), according to the drug's label.

That makes it much more potent than most of the over-the-counter fish oil supplements, and because it is produced according to FDA's good manufacturing practice standards, Omacor may be of higher quality than OTC supplements, said William Harris, Ph.D., director of lipid research at the Mid America Heart Institute in Kansas City, Mo.

“I think Omacor really is an advance in omega-3s,” said Dr. Harris, coauthor of the American Heart Association Nutrition Committee's recommendations on fish oil and an investigator in the FDA approval trial for Pronova Biocare AS, a Norwegian company that developed Omacor. In that study, 84 patients with severe hypertriglyceridemia (with an average 900 mg/dL) were randomized to placebo or Omacor. Patients taking Omacor had a 45% drop in triglyceride levels. Dr. Harris has received no other financial support from the company.

The AHA recommended in 2002 that patients with documented coronary heart disease should consume at least 1 gram of omega-3 fatty acids daily. Ideally, the omega-3s should come from fatty fish, but the AHA said that patients could take supplements.

To lower triglycerides, patients need to consume at least 2–4 g of omega-3 fatty acids daily, according to the guidelines. Omacor or OTC fish oil should be used in conjunction with niacin or fibrate therapies, Dr. Harris added.

The label recommends that patients taking Omacor have their triglyceride levels closely monitored, and that if they don't respond within 2 months, the drug should be stopped. Patients taking anticoagulants should also be monitored, as there have been some reports of prolonged bleeding with omega-3s.

Reliant Pharmaceuticals Inc. will market Omacor in the United States.

WASHINGTON — Patients who develop neuropathy while taking the antibiotic Zyvox (linezolid) do so after prolonged overuse of the drug, a scientist with the Food and Drug Administration's division of anti-infective drugs reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Once the drug is discontinued, the neuropathy seems to resolve in only a minority of the affected patients, Olga Belen, M.D., said in presenting findings from a search of the FDA's adverse event report system from April 2000, when the drug was approved, to November 2003. Zyvox, an oxazolidinone, is made by Pfizer.

Dr. Belen found 55 reports of neuropathy: 41 cases of peripheral neuropathy, 4 of optic neuropathy, and 10 with both optic and other areas affected.

Fifty-two of the patients received 600 mg twice daily. The mean age was 51 years, with a range of 12-80 years. There were 24 male patients and 28 female, and 32 reports from the United States and 28 from overseas.

Neuropathies had not been observed in preclinical or clinical studies, but they began to appear in the postmarketing period. Pfizer added language to Zyvox's label in December 2002 saying that neuropathies had been reported, but usually in patients treated for longer than the recommended maximum treatment period of 28 days.

The recommended duration of Zyvox treatment for complicated and uncomplicated skin and skin structure infections and community-acquired pneumonia is 10-14 days. For the indication of vancomycin-resistant Enterococcus faecium infections, the recommended treatment is 600 mg intravenously or orally twice daily, for 14-28 days.

But the median duration of treatment for patients who had neuropathies was 127 days—well beyond the recommended treatment period. The majority of patients with neuropathies had been taking Zyvox for 90-180 days, Dr. Belen said at the conference, sponsored by the American Society for Microbiology.

Of the 55, nine patients recovered, nine had a partial recovery, and 15 had not recovered at the last reported follow-up. There were no outcomes reported for 22 patients.

Dr. Belen said she could not draw a conclusion that Zyvox was responsible for the neuropathies reported, since the adverse event report database is just a passive collector of information. The case series “provides a temporal association with neuropathy,” she said.

When asked why there had been such long duration of use in the reports, Dr. Belen said it seemed that much of the use was for joint and lung infections, which may have prompted physicians to prescribe for longer periods.

WASHINGTON — Patients who develop neuropathy while taking the antibiotic Zyvox (linezolid) do so after prolonged overuse of the drug, a scientist with the Food and Drug Administration's division of anti-infective drugs reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Once the drug is discontinued, the neuropathy seems to resolve in only a minority of the affected patients, Olga Belen, M.D., said in presenting findings from a search of the FDA's adverse event report system from April 2000, when the drug was approved, to November 2003. Zyvox, an oxazolidinone, is made by Pfizer.

Dr. Belen found 55 reports of neuropathy: 41 cases of peripheral neuropathy, 4 of optic neuropathy, and 10 with both optic and other areas affected.

Fifty-two of the patients received 600 mg twice daily. The mean age was 51 years, with a range of 12-80 years. There were 24 male patients and 28 female, and 32 reports from the United States and 28 from overseas.

Neuropathies had not been observed in preclinical or clinical studies, but they began to appear in the postmarketing period. Pfizer added language to Zyvox's label in December 2002 saying that neuropathies had been reported, but usually in patients treated for longer than the recommended maximum treatment period of 28 days.

The recommended duration of Zyvox treatment for complicated and uncomplicated skin and skin structure infections and community-acquired pneumonia is 10-14 days. For the indication of vancomycin-resistant Enterococcus faecium infections, the recommended treatment is 600 mg intravenously or orally twice daily, for 14-28 days.

But the median duration of treatment for patients who had neuropathies was 127 days—well beyond the recommended treatment period. The majority of patients with neuropathies had been taking Zyvox for 90-180 days, Dr. Belen said at the conference, sponsored by the American Society for Microbiology.

Of the 55, nine patients recovered, nine had a partial recovery, and 15 had not recovered at the last reported follow-up. There were no outcomes reported for 22 patients.

Dr. Belen said she could not draw a conclusion that Zyvox was responsible for the neuropathies reported, since the adverse event report database is just a passive collector of information. The case series “provides a temporal association with neuropathy,” she said.

When asked why there had been such long duration of use in the reports, Dr. Belen said it seemed that much of the use was for joint and lung infections, which may have prompted physicians to prescribe for longer periods.

WASHINGTON — Patients who develop neuropathy while taking the antibiotic Zyvox (linezolid) do so after prolonged overuse of the drug, a scientist with the Food and Drug Administration's division of anti-infective drugs reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Once the drug is discontinued, the neuropathy seems to resolve in only a minority of the affected patients, Olga Belen, M.D., said in presenting findings from a search of the FDA's adverse event report system from April 2000, when the drug was approved, to November 2003. Zyvox, an oxazolidinone, is made by Pfizer.

Dr. Belen found 55 reports of neuropathy: 41 cases of peripheral neuropathy, 4 of optic neuropathy, and 10 with both optic and other areas affected.

Fifty-two of the patients received 600 mg twice daily. The mean age was 51 years, with a range of 12-80 years. There were 24 male patients and 28 female, and 32 reports from the United States and 28 from overseas.

Neuropathies had not been observed in preclinical or clinical studies, but they began to appear in the postmarketing period. Pfizer added language to Zyvox's label in December 2002 saying that neuropathies had been reported, but usually in patients treated for longer than the recommended maximum treatment period of 28 days.

The recommended duration of Zyvox treatment for complicated and uncomplicated skin and skin structure infections and community-acquired pneumonia is 10-14 days. For the indication of vancomycin-resistant Enterococcus faecium infections, the recommended treatment is 600 mg intravenously or orally twice daily, for 14-28 days.

But the median duration of treatment for patients who had neuropathies was 127 days—well beyond the recommended treatment period. The majority of patients with neuropathies had been taking Zyvox for 90-180 days, Dr. Belen said at the conference, sponsored by the American Society for Microbiology.

Of the 55, nine patients recovered, nine had a partial recovery, and 15 had not recovered at the last reported follow-up. There were no outcomes reported for 22 patients.

Dr. Belen said she could not draw a conclusion that Zyvox was responsible for the neuropathies reported, since the adverse event report database is just a passive collector of information. The case series “provides a temporal association with neuropathy,” she said.

When asked why there had been such long duration of use in the reports, Dr. Belen said it seemed that much of the use was for joint and lung infections, which may have prompted physicians to prescribe for longer periods.

ROCKVILLE, MD. – The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

“Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy,” acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said. FDA officials said that until now, pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency–which by law must approve everything about a drug's label–might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an “electronic pedigree,” allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

“The entire chain of custody can be followed,” said Dr. Rudolf.

“The threat [of counterfeiting] is real and needs to be addressed in a real and strong way,” said William Hubbard, FDA's associate commissioner for policy and planning, who hastened to add that the “drug supply in this country is very safe now.”

There have been instances, however, when impurities have been found in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with “nothing more than tap water,” said Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year. Viagra is one of the most counterfeited medicines in the United States, the company said.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A recent report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.

ROCKVILLE, MD. – The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

“Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy,” acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said. FDA officials said that until now, pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency–which by law must approve everything about a drug's label–might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an “electronic pedigree,” allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

“The entire chain of custody can be followed,” said Dr. Rudolf.

“The threat [of counterfeiting] is real and needs to be addressed in a real and strong way,” said William Hubbard, FDA's associate commissioner for policy and planning, who hastened to add that the “drug supply in this country is very safe now.”

There have been instances, however, when impurities have been found in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with “nothing more than tap water,” said Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year. Viagra is one of the most counterfeited medicines in the United States, the company said.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A recent report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.

ROCKVILLE, MD. – The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

“Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy,” acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said. FDA officials said that until now, pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency–which by law must approve everything about a drug's label–might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an “electronic pedigree,” allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

“The entire chain of custody can be followed,” said Dr. Rudolf.

“The threat [of counterfeiting] is real and needs to be addressed in a real and strong way,” said William Hubbard, FDA's associate commissioner for policy and planning, who hastened to add that the “drug supply in this country is very safe now.”

There have been instances, however, when impurities have been found in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with “nothing more than tap water,” said Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year. Viagra is one of the most counterfeited medicines in the United States, the company said.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A recent report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.

ROCKVILLE, MD. — The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

"Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said.

FDA officials said that until now pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency—which by law must approve everything about a drug's label—might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an "electronic pedigree," allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

"The entire chain of custody can be followed," Dr. Rudolf said.

"The threat [of counterfeiting] is real and needs to be addressed in a real and strong way," said William Hubbard, FDA's associate commissioner for policy and planning, who added that the "drug supply in this country is very safe now."

There have been some instances, however, when impurities have been discovered in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with "nothing more than tap water," explained Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.

ROCKVILLE, MD. — The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

"Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said.

FDA officials said that until now pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency—which by law must approve everything about a drug's label—might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an "electronic pedigree," allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

"The entire chain of custody can be followed," Dr. Rudolf said.

"The threat [of counterfeiting] is real and needs to be addressed in a real and strong way," said William Hubbard, FDA's associate commissioner for policy and planning, who added that the "drug supply in this country is very safe now."

There have been some instances, however, when impurities have been discovered in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with "nothing more than tap water," explained Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.

ROCKVILLE, MD. — The Food and Drug Administration has reassured pharmaceutical companies that they can use radio frequency identification technology in product packaging without running afoul of agency rules, at least through 2007.

"Today's actions were designed with one goal in mind: to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy," acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., said in a press briefing sponsored by the FDA.

At the same time, Purdue Pharma LP, Pfizer, and GlaxoSmithKline all said they soon would begin using radio frequency identification (RFID) technology in packaging for some of their products.

RFID is slowly being adopted by retailers to track inventory. Tags that contain information about the product can be embedded into pallets or labels and then read by wireless scanners.

The new FDA policy should convince drug makers that they can safely use RFID tags, said Paul Rudolf, M.D., FDA senior adviser for medical and health policy. Between now and 2007, companies can experiment with RFID without fear of sanctions, he said.

FDA officials said that until now pharmaceutical manufacturers have hesitated to incorporate the tags into their products out of concern that the agency—which by law must approve everything about a drug's label—might then consider a drug mislabeled.

The agency believes RFID technology could also deter counterfeiting. A tag could be embedded into a large pill bottle or block of packages at the factory, with information on the drug's potency, its destination, and other important data. Using special scanners and software, the distributor and the pharmacy will then be able to read the tag. RFID will help create an "electronic pedigree," allowing manufacturers, distributors, and pharmacists to verify the drug's legitimacy, according to the FDA.

"The entire chain of custody can be followed," Dr. Rudolf said.

"The threat [of counterfeiting] is real and needs to be addressed in a real and strong way," said William Hubbard, FDA's associate commissioner for policy and planning, who added that the "drug supply in this country is very safe now."

There have been some instances, however, when impurities have been discovered in counterfeit pharmaceuticals, and in one case, where an injectable drug was filled with "nothing more than tap water," explained Thomas McGinnis, Pharm.D., FDA's director of pharmacy affairs.

At press time, Purdue Pharma, which has weathered difficulties with theft and diversion of its pain killer OxyContin (oxycodone), said it would begin sending RFID-tagged 100-tablet bottles to Wal-Mart and H.D. Smith Wholesale Drug Co. The company is also donating 100 handheld scanners to law enforcement groups around the country and using special color-shifting ink on the label that will let pharmacists know that the bottle came from Purdue.

GlaxoSmithKline said it would start using RFID tags on at least one of its products deemed to be susceptible to counterfeiting in the next year-and-a-half. Those products include Retrovir (zidovudine), Combivir (lamivudine/zidovudine), Epivir (lamivudine), Trizivir (abacavir, lamivudine, and zidovudine), Ziagen (abacavir), and Zofran (ondansetron), according to the company.

Pfizer said that it expected to have RFID tags for Viagra (sildenafil) by the end of next year.

Dr. Rudolf added that he did not expect the cost of anticounterfeiting technology to be passed on to consumers, as it would save money by curbing counterfeiting.

A report by the Healthcare Distribution Management Association's Healthcare Foundation seems to back up that assertion: The report estimated that $200 million to $400 million could be saved each year by decreasing drug counterfeiting.