Elizabeth Mechcatie

Pregabalin, a drug that binds to calcium channels in the central nervous system, has received Food and Drug Administration approval for the management of pain associated with postherpetic neuralgia and diabetic peripheral neuropathy, making it the first drug indicated for both neuropathic pain conditions.

Pregabalin is the second drug approved specifically for treating pain associated with diabetic peripheral neuropathy (DPN); duloxetine (Cymbalta), was approved in September for this use. Other drugs approved for postherpetic neuralgia (PHN) pain are gabapentin (Neurontin) and the 5% lidocaine patch.

Pregabalin will not be available until the Drug Enforcement Administration decides on its controlled substance category. A company spokesperson would not speculate about when pregabalin would become available in pharmacies and declined to provide details on why it is under review as a controlled substance.

The two approvals were based on six placebo-controlled, double-blind studies involving more than 1,000 patients—three studies in patients with PHN and three in patients with DPN. Findings showed the drug provided quick and clinically meaningful pain reduction in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

In DPN trials, about half the patients had at least a 50% response rate and in PHN trials, the response rates were a little lower, but “still considered impressive,” said Brett R. Stacey, M.D., one of the trial investigators.

Pregabalin will act more quickly to lessen pain than tricyclic antidepressants, which need to be started at a low dose, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland.

The time to onset of pain relief can begin the day after the start of treatment, he added. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, he said.

Dr. Stacey has done paid research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

The recommended dosage for pain after shingles is 150-300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the Pfizer spokesperson. The diabetic nerve pain recommended dosage is 300 mg per day, given in three doses.

Where this fits in with other available treatments depends on various factors, including price, he said. If it is reasonably priced, he said he would be more likely to start patients on the drug. It will be helpful in patients with contraindications to tricyclics and is worth trying in patients who have been treated with gabapentin and continue to have pain, he added. (Price was not available at press time.)

Pregabalin, a drug that binds to calcium channels in the central nervous system, has received Food and Drug Administration approval for the management of pain associated with postherpetic neuralgia and diabetic peripheral neuropathy, making it the first drug indicated for both neuropathic pain conditions.

Pregabalin is the second drug approved specifically for treating pain associated with diabetic peripheral neuropathy (DPN); duloxetine (Cymbalta), was approved in September for this use. Other drugs approved for postherpetic neuralgia (PHN) pain are gabapentin (Neurontin) and the 5% lidocaine patch.

Pregabalin will not be available until the Drug Enforcement Administration decides on its controlled substance category. A company spokesperson would not speculate about when pregabalin would become available in pharmacies and declined to provide details on why it is under review as a controlled substance.

The two approvals were based on six placebo-controlled, double-blind studies involving more than 1,000 patients—three studies in patients with PHN and three in patients with DPN. Findings showed the drug provided quick and clinically meaningful pain reduction in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

In DPN trials, about half the patients had at least a 50% response rate and in PHN trials, the response rates were a little lower, but “still considered impressive,” said Brett R. Stacey, M.D., one of the trial investigators.

Pregabalin will act more quickly to lessen pain than tricyclic antidepressants, which need to be started at a low dose, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland.

The time to onset of pain relief can begin the day after the start of treatment, he added. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, he said.

Dr. Stacey has done paid research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

The recommended dosage for pain after shingles is 150-300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the Pfizer spokesperson. The diabetic nerve pain recommended dosage is 300 mg per day, given in three doses.

Where this fits in with other available treatments depends on various factors, including price, he said. If it is reasonably priced, he said he would be more likely to start patients on the drug. It will be helpful in patients with contraindications to tricyclics and is worth trying in patients who have been treated with gabapentin and continue to have pain, he added. (Price was not available at press time.)

Pregabalin, a drug that binds to calcium channels in the central nervous system, has received Food and Drug Administration approval for the management of pain associated with postherpetic neuralgia and diabetic peripheral neuropathy, making it the first drug indicated for both neuropathic pain conditions.

Pregabalin is the second drug approved specifically for treating pain associated with diabetic peripheral neuropathy (DPN); duloxetine (Cymbalta), was approved in September for this use. Other drugs approved for postherpetic neuralgia (PHN) pain are gabapentin (Neurontin) and the 5% lidocaine patch.

Pregabalin will not be available until the Drug Enforcement Administration decides on its controlled substance category. A company spokesperson would not speculate about when pregabalin would become available in pharmacies and declined to provide details on why it is under review as a controlled substance.

The two approvals were based on six placebo-controlled, double-blind studies involving more than 1,000 patients—three studies in patients with PHN and three in patients with DPN. Findings showed the drug provided quick and clinically meaningful pain reduction in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

In DPN trials, about half the patients had at least a 50% response rate and in PHN trials, the response rates were a little lower, but “still considered impressive,” said Brett R. Stacey, M.D., one of the trial investigators.

Pregabalin will act more quickly to lessen pain than tricyclic antidepressants, which need to be started at a low dose, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland.

The time to onset of pain relief can begin the day after the start of treatment, he added. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, he said.

Dr. Stacey has done paid research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

The recommended dosage for pain after shingles is 150-300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the Pfizer spokesperson. The diabetic nerve pain recommended dosage is 300 mg per day, given in three doses.

Where this fits in with other available treatments depends on various factors, including price, he said. If it is reasonably priced, he said he would be more likely to start patients on the drug. It will be helpful in patients with contraindications to tricyclics and is worth trying in patients who have been treated with gabapentin and continue to have pain, he added. (Price was not available at press time.)

An intrathecal formulation of a synthetic version of a toxin used by a fish-eating marine snail to catch its prey has been approved as a treatment for severe, chronic pain.

The Food and Drug Administration approved the nonopiod ziconotide for intrathecal (IT) infusion for managing severe chronic pain “in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.” It is being marketed under the trade name Prialt by Elan Pharmaceuticals Inc.

Ziconotide is a synthetic version of a conopeptide used by the Conus magus sea snail to sting fish. In nature the toxin “is so powerful it stops the fish dead in its track, and the snail eats it,” said Mark Wallace, M.D., director, center for pain and palliative medicine at the University of California, San Diego.

The synthetic version of this “conotoxin” is an N-type calcium channel antagonist. N-type calcium channels are located mainly in the dorsal horn cells of the spinal cord, predominantly on the superficial layers, in the area of substantia gelatinosa where pain fibers synapse, Dr. Wallace explained.

Ziconotide “blocks those calcium channels at the level where these pain fibers meet up,” essentially shutting them down, he said, noting that opioids also have the same effect.

The three trials that led to the approval included patients with “really refractory” pain due to various causes, including low back pain, cancer pain, neuropathic pain, pain from nervous system injuries, and HIV-related pain, said Dr. Wallace, an investigator in the studies and a consultant to the manufacturer.

The most recent trial was a multicenter study in 220 patients with severe chronic pain, described by most as refractory to treatments including IT morphine.

Patients were first taken off IT medications and stabilized on analgesics that included opiates and then treated with placebo or ziconotide.

At 3 weeks, pain scores had improved by a mean of 12% from baseline vs. a mean of 5% for patients given placebo therapy, which was a highly significant difference.

During treatment, the use of non-IT opioids dropped by 24% among patients on ziconotide, compared with 17% among those on placebo.

An intrathecal formulation of a synthetic version of a toxin used by a fish-eating marine snail to catch its prey has been approved as a treatment for severe, chronic pain.

The Food and Drug Administration approved the nonopiod ziconotide for intrathecal (IT) infusion for managing severe chronic pain “in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.” It is being marketed under the trade name Prialt by Elan Pharmaceuticals Inc.

Ziconotide is a synthetic version of a conopeptide used by the Conus magus sea snail to sting fish. In nature the toxin “is so powerful it stops the fish dead in its track, and the snail eats it,” said Mark Wallace, M.D., director, center for pain and palliative medicine at the University of California, San Diego.

The synthetic version of this “conotoxin” is an N-type calcium channel antagonist. N-type calcium channels are located mainly in the dorsal horn cells of the spinal cord, predominantly on the superficial layers, in the area of substantia gelatinosa where pain fibers synapse, Dr. Wallace explained.

Ziconotide “blocks those calcium channels at the level where these pain fibers meet up,” essentially shutting them down, he said, noting that opioids also have the same effect.

The three trials that led to the approval included patients with “really refractory” pain due to various causes, including low back pain, cancer pain, neuropathic pain, pain from nervous system injuries, and HIV-related pain, said Dr. Wallace, an investigator in the studies and a consultant to the manufacturer.

The most recent trial was a multicenter study in 220 patients with severe chronic pain, described by most as refractory to treatments including IT morphine.

Patients were first taken off IT medications and stabilized on analgesics that included opiates and then treated with placebo or ziconotide.

At 3 weeks, pain scores had improved by a mean of 12% from baseline vs. a mean of 5% for patients given placebo therapy, which was a highly significant difference.

During treatment, the use of non-IT opioids dropped by 24% among patients on ziconotide, compared with 17% among those on placebo.

An intrathecal formulation of a synthetic version of a toxin used by a fish-eating marine snail to catch its prey has been approved as a treatment for severe, chronic pain.

The Food and Drug Administration approved the nonopiod ziconotide for intrathecal (IT) infusion for managing severe chronic pain “in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.” It is being marketed under the trade name Prialt by Elan Pharmaceuticals Inc.

Ziconotide is a synthetic version of a conopeptide used by the Conus magus sea snail to sting fish. In nature the toxin “is so powerful it stops the fish dead in its track, and the snail eats it,” said Mark Wallace, M.D., director, center for pain and palliative medicine at the University of California, San Diego.

The synthetic version of this “conotoxin” is an N-type calcium channel antagonist. N-type calcium channels are located mainly in the dorsal horn cells of the spinal cord, predominantly on the superficial layers, in the area of substantia gelatinosa where pain fibers synapse, Dr. Wallace explained.

Ziconotide “blocks those calcium channels at the level where these pain fibers meet up,” essentially shutting them down, he said, noting that opioids also have the same effect.

The three trials that led to the approval included patients with “really refractory” pain due to various causes, including low back pain, cancer pain, neuropathic pain, pain from nervous system injuries, and HIV-related pain, said Dr. Wallace, an investigator in the studies and a consultant to the manufacturer.

The most recent trial was a multicenter study in 220 patients with severe chronic pain, described by most as refractory to treatments including IT morphine.

Patients were first taken off IT medications and stabilized on analgesics that included opiates and then treated with placebo or ziconotide.

At 3 weeks, pain scores had improved by a mean of 12% from baseline vs. a mean of 5% for patients given placebo therapy, which was a highly significant difference.

During treatment, the use of non-IT opioids dropped by 24% among patients on ziconotide, compared with 17% among those on placebo.

Pregabalin, a drug that binds to calcium channels in the central nervous system, was approved by the Food and Drug Administration for the management of pain associated with postherpetic neuralgia in late December 2004.

There are now three FDA-approved treatments for this indication; the others are gabapentin (Neurontin) and the 5% lidocaine patch. The FDA also approved pregabalin for the pain associated with diabetic neuropathy.

The approvals were based on six placebo-controlled, double-blind studies–three in patients with postherpetic neuralgia. The studies showed the drug provided quick and clinically meaningful reductions in pain in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

For postherpetic neuralgia, “the time course to pain relief will be much quicker” than with treatments such as tricyclic antidepressants. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, said Brett R. Stacey, M.D., one of the trial investigators.

Like gabapentin, pregabalin binds to a specific subunit of one of the calcium channels, but pregabalin “appears to bind more avidly” than gabapentin, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland. The time to onset of pain relief can begin the day after treatment is started, he added.

Side effects have been tolerable and not hugely problematic and are the same as with other CNS drugs; sedation and dizziness are two of the most common ones reported by patients, Dr. Stacey said.

Pregabalin is not yet available. It is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse, compared with other controlled substances, according to Pfizer. A company spokesperson said the Drug Enforcement Administration is reviewing the classification, and until that decision is made, pregabalin will not be available. But Pfizer expects it to become available “in the near future.”

The recommended dosage for pain after shingles is 150–300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the spokesperson.

Dr. Stacey has done research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

Pregabalin, a drug that binds to calcium channels in the central nervous system, was approved by the Food and Drug Administration for the management of pain associated with postherpetic neuralgia in late December 2004.

There are now three FDA-approved treatments for this indication; the others are gabapentin (Neurontin) and the 5% lidocaine patch. The FDA also approved pregabalin for the pain associated with diabetic neuropathy.

The approvals were based on six placebo-controlled, double-blind studies–three in patients with postherpetic neuralgia. The studies showed the drug provided quick and clinically meaningful reductions in pain in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

For postherpetic neuralgia, “the time course to pain relief will be much quicker” than with treatments such as tricyclic antidepressants. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, said Brett R. Stacey, M.D., one of the trial investigators.

Like gabapentin, pregabalin binds to a specific subunit of one of the calcium channels, but pregabalin “appears to bind more avidly” than gabapentin, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland. The time to onset of pain relief can begin the day after treatment is started, he added.

Side effects have been tolerable and not hugely problematic and are the same as with other CNS drugs; sedation and dizziness are two of the most common ones reported by patients, Dr. Stacey said.

Pregabalin is not yet available. It is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse, compared with other controlled substances, according to Pfizer. A company spokesperson said the Drug Enforcement Administration is reviewing the classification, and until that decision is made, pregabalin will not be available. But Pfizer expects it to become available “in the near future.”

The recommended dosage for pain after shingles is 150–300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the spokesperson.

Dr. Stacey has done research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

Pregabalin, a drug that binds to calcium channels in the central nervous system, was approved by the Food and Drug Administration for the management of pain associated with postherpetic neuralgia in late December 2004.

There are now three FDA-approved treatments for this indication; the others are gabapentin (Neurontin) and the 5% lidocaine patch. The FDA also approved pregabalin for the pain associated with diabetic neuropathy.

The approvals were based on six placebo-controlled, double-blind studies–three in patients with postherpetic neuralgia. The studies showed the drug provided quick and clinically meaningful reductions in pain in a significant proportion of patients, according to Pfizer, which will market pregabalin under the trade name Lyrica.

For postherpetic neuralgia, “the time course to pain relief will be much quicker” than with treatments such as tricyclic antidepressants. Pregabalin also has a narrow dose range, which will make it easier to prescribe than gabapentin, which has a “huge” dose range because of variable absorption across the GI tract, said Brett R. Stacey, M.D., one of the trial investigators.

Like gabapentin, pregabalin binds to a specific subunit of one of the calcium channels, but pregabalin “appears to bind more avidly” than gabapentin, said Dr. Stacey, medical director of the comprehensive pain center at Oregon Health and Science University, Portland. The time to onset of pain relief can begin the day after treatment is started, he added.

Side effects have been tolerable and not hugely problematic and are the same as with other CNS drugs; sedation and dizziness are two of the most common ones reported by patients, Dr. Stacey said.

Pregabalin is not yet available. It is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse, compared with other controlled substances, according to Pfizer. A company spokesperson said the Drug Enforcement Administration is reviewing the classification, and until that decision is made, pregabalin will not be available. But Pfizer expects it to become available “in the near future.”

The recommended dosage for pain after shingles is 150–300 mg per day, given in two or three doses; the dosage can be increased up to 600 mg per day, based on tolerability, if patients do not experience sufficient reductions in pain, according to the spokesperson.

Dr. Stacey has done research for Pfizer and has been a consultant to the company for gabapentin and pregabalin.

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place with resulting cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the FDA acknowledged Janssen's intention to change the name of all Reminyl products. At press time, the new name had not been announced. Amaryl has been the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl is the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Errors should be reported by calling the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088. Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place with resulting cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the FDA acknowledged Janssen's intention to change the name of all Reminyl products. At press time, the new name had not been announced. Amaryl has been the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl is the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Errors should be reported by calling the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088. Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place with resulting cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the FDA acknowledged Janssen's intention to change the name of all Reminyl products. At press time, the new name had not been announced. Amaryl has been the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl is the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Errors should be reported by calling the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088. Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place. The mix-ups have resulted in cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the Food and Drug Administration acknowledged Janssen's intention to change the name of all Reminyl products.

At press time, the new name had not been announced.

Amaryl is the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl has been the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and to the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Making the confusion more likely is that both drugs come in 4-mg strengths and in tablet formulations. And because both generic names start with the letter g, the drugs may be stored near each other.

The starting dose of Reminyl is 4 mg twice a day, while the starting dose of Amaryl is 1-2 mg twice a day, with a maximal starting dosage of 2 mg, the letter states.

Health care professionals who become aware of these or any other medication errors should call the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088.

Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place. The mix-ups have resulted in cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the Food and Drug Administration acknowledged Janssen's intention to change the name of all Reminyl products.

At press time, the new name had not been announced.

Amaryl is the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl has been the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and to the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Making the confusion more likely is that both drugs come in 4-mg strengths and in tablet formulations. And because both generic names start with the letter g, the drugs may be stored near each other.

The starting dose of Reminyl is 4 mg twice a day, while the starting dose of Amaryl is 1-2 mg twice a day, with a maximal starting dosage of 2 mg, the letter states.

Health care professionals who become aware of these or any other medication errors should call the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088.

Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

Janssen Pharmaceutica has agreed to change the name of its Alzheimer's drug Reminyl in response to inadvertent dispensing of the oral blood glucose-lowering drug Amaryl in its place. The mix-ups have resulted in cases of severe hypoglycemia and other serious adverse events, including one fatality.

In a Dec. 22, 2004, letter, the Food and Drug Administration acknowledged Janssen's intention to change the name of all Reminyl products.

At press time, the new name had not been announced.

Amaryl is the trade name for glimepiride, which is approved for treating type 2 diabetes and is marketed by Aventis. Reminyl has been the trade name for galantamine, which is approved for mild to moderate dementia of the Alzheimer's type and is marketed by Janssen Pharmaceutica.

Spontaneous reports submitted to the FDA and to the U.S. Pharmacopeia have described prescriptions that have been “incorrectly written, interpreted, labeled, and/or filled due to the similarity” between the two trade names, according to a “Dear Health Care Provider” letter issued by Janssen. The letter was posted on the FDA's MedWatch Web site (www.fda.gov/medwatch

Making the confusion more likely is that both drugs come in 4-mg strengths and in tablet formulations. And because both generic names start with the letter g, the drugs may be stored near each other.

The starting dose of Reminyl is 4 mg twice a day, while the starting dose of Amaryl is 1-2 mg twice a day, with a maximal starting dosage of 2 mg, the letter states.

Health care professionals who become aware of these or any other medication errors should call the USP Medication Errors Reporting Program, at 800-23ERROR or 800-FAIL-SAF; or the FDA's MedWatch Adverse Event Reporting Program at 800-FDA-1088.

Errors also can be reported to the manufacturers: 800-526-7736 (Janssen) or 800-633-1610 (Aventis).

In the wake of the withdrawal of rofecoxib and the addition of a black box warning for antidepressants, the Food and Drug Administration last month announced a plan aimed at strengthening its safety program for drugs.

A main component of the plan is an FDA-sponsored study by the Institute of Medicine that will evaluate the current drug safety system, with emphasis on the postmarketing phase. The IOM study will assess what additional steps could be taken to learn more about the adverse effects of drugs once they are on the market. The FDA also plans to create a system to adjudicate differences of professional opinion within its Center for Drug Evaluation and Research (CDER) concerning a particular drug, a situation that was widely reported to be an issue with the rofecoxib and antidepressant safety reviews. Workshops and advisory committee meetings where drug safety and risk management issues will be discussed are also planned for next year, including an advisory panel meeting next February on the safety of the cyclooxygenase-2 (COX-2) inhibitors.

These efforts are aimed at "keeping the agency on the cutting edge of public health protection, with regard to the risks of pharmaceutical products," and to "enhance the confidence" of Americans in the safety of the drugs they are prescribed, Steven Galson, M.D., acting CDER director, Rockville, Md., said during a telephone press briefing held to announce the FDA's plans.

Postmarketing drug safety has become a prominent issue. The FDA has been widely criticized for not acting quickly enough on these issues.

Using the selective serotonin reuptake inhibitors (SSRIs) and rofecoxib as recent examples of drugs with serious adverse events that emerged after marketing, Dr. Galson said that, clearly, the FDA does not always understand the "full magnitude" of a particular drug's risks before approval. When adverse events are identified in postapproval clinical trials, or by spontaneous reporting of the events to the FDA and/or pharmaceutical manufacturers, the agency takes a proactive approach, he said, with experts in clinical medicine and epidemiology evaluating the new data and determining the impact on the risk-benefit balance of the products.

Responding to the criticism that the agency acted too slowly on these two major safety issues, Dr. Galson said that "there will always be discussions in the health care community about the speed with which we make postmarketing regulatory decisions," and the methods used to make those decisions.

He said that no particular issue instigated the decision to contract with the IOM for a study of the FDA's drug safety program—the study has been under consideration for years.

The effort to adjudicate differences in professional opinion is geared toward ensuring that the opinions of all FDA reviewers are incorporated into its decision-making process when there are disagreements.

With both rofecoxib and antidepressants, attention has focused on a particular reviewer who raised safety questions, which reportedly were not given sufficient weight. These cases are "extremely rare," and the amount of publicity they received are disproportional to the number of drug safety consultations "that go really, really well," Dr. Galson said.

And in response to criticism that rofecoxib should have been withdrawn much earlier, he added, "we think what happened to Vioxx is a demonstration that the system worked well," and that the public and health care professionals were notified when concerns about cardiovascular safety emerged. He said it would be too difficult to comment on how these two cases would have been different if the new measures had been in place.

Asked to comment on the plans, Curt Furberg, M.D., a member of the FDA's drug safety advisory committee, said that it was "a step in the right direction," but does not go far enough to ensure the safety of drugs once they are marketed.

This will remain a problem as long as the review of postmarketing drug safety remains within the FDA, where the same people who approve a drug then judge whether it should remain on the market, said Dr. Furberg, professor of public health sciences at Wake Forest University, Winston-Salem, N.C.

In the wake of the withdrawal of rofecoxib and the addition of a black box warning for antidepressants, the Food and Drug Administration last month announced a plan aimed at strengthening its safety program for drugs.

A main component of the plan is an FDA-sponsored study by the Institute of Medicine that will evaluate the current drug safety system, with emphasis on the postmarketing phase. The IOM study will assess what additional steps could be taken to learn more about the adverse effects of drugs once they are on the market. The FDA also plans to create a system to adjudicate differences of professional opinion within its Center for Drug Evaluation and Research (CDER) concerning a particular drug, a situation that was widely reported to be an issue with the rofecoxib and antidepressant safety reviews. Workshops and advisory committee meetings where drug safety and risk management issues will be discussed are also planned for next year, including an advisory panel meeting next February on the safety of the cyclooxygenase-2 (COX-2) inhibitors.

These efforts are aimed at "keeping the agency on the cutting edge of public health protection, with regard to the risks of pharmaceutical products," and to "enhance the confidence" of Americans in the safety of the drugs they are prescribed, Steven Galson, M.D., acting CDER director, Rockville, Md., said during a telephone press briefing held to announce the FDA's plans.

Postmarketing drug safety has become a prominent issue. The FDA has been widely criticized for not acting quickly enough on these issues.

Using the selective serotonin reuptake inhibitors (SSRIs) and rofecoxib as recent examples of drugs with serious adverse events that emerged after marketing, Dr. Galson said that, clearly, the FDA does not always understand the "full magnitude" of a particular drug's risks before approval. When adverse events are identified in postapproval clinical trials, or by spontaneous reporting of the events to the FDA and/or pharmaceutical manufacturers, the agency takes a proactive approach, he said, with experts in clinical medicine and epidemiology evaluating the new data and determining the impact on the risk-benefit balance of the products.

Responding to the criticism that the agency acted too slowly on these two major safety issues, Dr. Galson said that "there will always be discussions in the health care community about the speed with which we make postmarketing regulatory decisions," and the methods used to make those decisions.

He said that no particular issue instigated the decision to contract with the IOM for a study of the FDA's drug safety program—the study has been under consideration for years.

The effort to adjudicate differences in professional opinion is geared toward ensuring that the opinions of all FDA reviewers are incorporated into its decision-making process when there are disagreements.

With both rofecoxib and antidepressants, attention has focused on a particular reviewer who raised safety questions, which reportedly were not given sufficient weight. These cases are "extremely rare," and the amount of publicity they received are disproportional to the number of drug safety consultations "that go really, really well," Dr. Galson said.

And in response to criticism that rofecoxib should have been withdrawn much earlier, he added, "we think what happened to Vioxx is a demonstration that the system worked well," and that the public and health care professionals were notified when concerns about cardiovascular safety emerged. He said it would be too difficult to comment on how these two cases would have been different if the new measures had been in place.

Asked to comment on the plans, Curt Furberg, M.D., a member of the FDA's drug safety advisory committee, said that it was "a step in the right direction," but does not go far enough to ensure the safety of drugs once they are marketed.

This will remain a problem as long as the review of postmarketing drug safety remains within the FDA, where the same people who approve a drug then judge whether it should remain on the market, said Dr. Furberg, professor of public health sciences at Wake Forest University, Winston-Salem, N.C.

In the wake of the withdrawal of rofecoxib and the addition of a black box warning for antidepressants, the Food and Drug Administration last month announced a plan aimed at strengthening its safety program for drugs.

A main component of the plan is an FDA-sponsored study by the Institute of Medicine that will evaluate the current drug safety system, with emphasis on the postmarketing phase. The IOM study will assess what additional steps could be taken to learn more about the adverse effects of drugs once they are on the market. The FDA also plans to create a system to adjudicate differences of professional opinion within its Center for Drug Evaluation and Research (CDER) concerning a particular drug, a situation that was widely reported to be an issue with the rofecoxib and antidepressant safety reviews. Workshops and advisory committee meetings where drug safety and risk management issues will be discussed are also planned for next year, including an advisory panel meeting next February on the safety of the cyclooxygenase-2 (COX-2) inhibitors.

These efforts are aimed at "keeping the agency on the cutting edge of public health protection, with regard to the risks of pharmaceutical products," and to "enhance the confidence" of Americans in the safety of the drugs they are prescribed, Steven Galson, M.D., acting CDER director, Rockville, Md., said during a telephone press briefing held to announce the FDA's plans.

Postmarketing drug safety has become a prominent issue. The FDA has been widely criticized for not acting quickly enough on these issues.

Using the selective serotonin reuptake inhibitors (SSRIs) and rofecoxib as recent examples of drugs with serious adverse events that emerged after marketing, Dr. Galson said that, clearly, the FDA does not always understand the "full magnitude" of a particular drug's risks before approval. When adverse events are identified in postapproval clinical trials, or by spontaneous reporting of the events to the FDA and/or pharmaceutical manufacturers, the agency takes a proactive approach, he said, with experts in clinical medicine and epidemiology evaluating the new data and determining the impact on the risk-benefit balance of the products.

Responding to the criticism that the agency acted too slowly on these two major safety issues, Dr. Galson said that "there will always be discussions in the health care community about the speed with which we make postmarketing regulatory decisions," and the methods used to make those decisions.

He said that no particular issue instigated the decision to contract with the IOM for a study of the FDA's drug safety program—the study has been under consideration for years.

The effort to adjudicate differences in professional opinion is geared toward ensuring that the opinions of all FDA reviewers are incorporated into its decision-making process when there are disagreements.

With both rofecoxib and antidepressants, attention has focused on a particular reviewer who raised safety questions, which reportedly were not given sufficient weight. These cases are "extremely rare," and the amount of publicity they received are disproportional to the number of drug safety consultations "that go really, really well," Dr. Galson said.

And in response to criticism that rofecoxib should have been withdrawn much earlier, he added, "we think what happened to Vioxx is a demonstration that the system worked well," and that the public and health care professionals were notified when concerns about cardiovascular safety emerged. He said it would be too difficult to comment on how these two cases would have been different if the new measures had been in place.

Asked to comment on the plans, Curt Furberg, M.D., a member of the FDA's drug safety advisory committee, said that it was "a step in the right direction," but does not go far enough to ensure the safety of drugs once they are marketed.

This will remain a problem as long as the review of postmarketing drug safety remains within the FDA, where the same people who approve a drug then judge whether it should remain on the market, said Dr. Furberg, professor of public health sciences at Wake Forest University, Winston-Salem, N.C.