FYI: THE NIH FUNDS NETWORK TO STUDY DRUG-INDUCED LIVER INJURY (DILIN)

>

> FOR IMMEDIATE RELEASE

> Friday, November 19, 2004

>

> CONTACTS:

> Curtis

> or Marcia Vital,

> 301- 496-3583

>

> THE NIH FUNDS NETWORK TO STUDY DRUG-INDUCED LIVER INJURY (DILIN)

>

> The National Institutes of Health (NIH) has launched a network of five

> clinical

> centers and a data coordinating center to conduct studies over the next

> three

> years of patients who have suffered severe liver injury because of both

> prescription and " over-the-counter medications, " nutritional supplements,

> alternative medicines and herbals. The DILIN centers are located in North

> Carolina, Indiana, San Francisco, Michigan, and Connecticut, and will be

> awarded

> $2.25 million per year.

>

> One objective of DILIN is to develop standardized definitions and

> instruments to

> identify and fully characterize cases of drug-induced liver injury. With a

> systematic way of classifying drug-induced liver injury, researchers will

> be

>

> able to analyze the epidemiology and clinical issues of liver injury and

> collect

> biological samples that can be used to study the causes of liver toxicity

> using

> biochemical, serological, and genetic testing. The DILIN is sponsored by

> the

>

> National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),

> one of

> the institutes of the NIH.

>

> Another objective of DILIN is to establish a registry of patients who have

> experienced severe drug induced liver injury. " Part of the difficulty in

> studying drug-induced liver disease is the absence of a sufficient cohort

> of

>

> well-characterized patients in whom to carry out clinical, genetic,

> immunological and biochemical investigation, " says Serrano, M.D.,

> Ph.D,

>

> director, NIDDKs' Liver and Biliary Diseases Program and coordinator of

> the

> DILIN. " DILIN will help to eliminate this barrier and advance the

> understanding

> of drug-induced liver injury forward, " he adds.

>

> Drug-induced liver injury occurs in all age groups, but most cases occur

> within

> the elderly population because they take more medications than younger

> persons

> and also use multiple medications. Furthermore, drug-induced liver injury

> is

> the

> most common reason why drugs are not approved by the Food and Drug

> Administration (FDA) or are removed from the market after they have been

> approved.

>

> Most drugs that can cause liver injury are entirely safe for the majority

> of

>

> patients taking them. The reason why some patients are susceptible to

> liver

> injury from a drug is rarely known. " It is likely a result of many

> interrelated

> factors that involve complex interactions between our genes and the

> environment, " says Jay Hoofnagle, M.D., director, NIDDK Liver Diseases

> Research

> Branch. " Liver injury is unpredictable and variable in clinical

> presentation,

> making causality very tough to assess, " explains Hoofnagle.

>

> At present, DILIN has developed protocols for both retrospective and

> prospective

> studies of drug-induced liver disease. The retrospective study will

> establish a

> registry of patients who have taken one of four specific drugs since 1994

> and

> developed liver injury later.

>

> The four drugs are isoniazid, phenytoin, valproic acid, and clavulanic

> acid/amoxicillin. These drugs were chosen because they are widely

> prescribed

> and

> have definite clinical presentation. A minimum of 50 cases of each form of

> drug-

> induced liver disease will be collected along with an equal number of

> patients

> who have taken the drugs safely (controls). The researchers will obtain

> clinical

> and DNA information from each patient.

>

> The prospective study will focus on enrolling patients who recently

> suffered

> an

> adverse liver reaction after taking any drug or herbal medicine. These

> patients

> will be followed over time to find out what happens to them as a result of

> their

> injury. Patients who have not sustained liver injury, but who have taken

> any

> of

> the drugs in question, will also be enrolled in the prospective study.

>

> " Overall, we believe that the DILIN will bring greater focus and interest

> to

> the

> study of drug-induced liver injury and help to develop better ways to

> prevent,

> detect, and treat this growing liver problem, " says Watkins, M.D.,

> chair,

> the DILIN Steering Committee and principal investigator for the center in

> North

> Carolina.

>

> The DILIN researchers have also developed diagnostic criteria and measures

> for

> grading causality in patients with drug-induced liver disease and will

> prospectively assess these instruments for sensitivity and specificity.

> Patient

> enrollment is ongoing.

>

> The DILIN consists of the following principal investigators and centers:

>

> Dr. Watkins, University of North Carolina, Chapel Hill, North

> Carolina

>

> Dr. Naga Chalasani, University of Indiana, Indianapolis, Indiana

>

> Dr. Davern, University of California, San Francisco, California

>

> Dr. Fontana, University of Michigan, Ann Arbor, Michigan

>

> Dr. Herbert Bonkovsky, University of Connecticut, Hartford, Connecticut

>

> Dr. Rochon, ( " Data Coordinating Center " ), Duke University,

> Raleigh-Durham,

> North Carolina

>

> For more information, contact Curtis or Marcia Vital at the NIDDK

> Information Office (301-496-3583).

>

> The National Institute of Diabetes and Digestive and Kidney Diseases

> (NIDDK)

> is

> a component of the National Institutes of Health (NIH), U.S. Department of

> Health and Human Services (DHHS). NIDDK supports a significant amount of

> the

>

> Federal Government's research on endocrine and metabolic diseases such as

> diabetes and obesity, digestive diseases such as hepatitis and

> inflammatory

> bowel disease, kidney and urologic diseases such as kidney failure and

> prostate

> enlargement, and blood diseases such as the anemias. The Institute carries

> out a

> large variety of research initiatives and programs that will bring new

> knowledge

> into proven therapies that benefit the public. Health information and

> additional

> information about NIDDK can be found on the NIDDK home page at:

>

> ##

>

> This NIH News Release is available online at:

> http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

>

> To subscribe (or unsubscribe) from this list, go to

>

November 20, 2004

> U.S. Department of Health and Human Services

>

> NATIONAL INSTITUTES OF HEALTH

>

> NIH News

>

> National Institute of Diabetes and

> Digestive and Kidney Diseases (NIDDK)

>

> FOR IMMEDIATE RELEASE

> Friday, November 19, 2004

>

> CONTACTS:

> Curtis

> or Marcia Vital,

> 301- 496-3583

>

> THE NIH FUNDS NETWORK TO STUDY DRUG-INDUCED LIVER INJURY (DILIN)

>

> The National Institutes of Health (NIH) has launched a network of five

> clinical

> centers and a data coordinating center to conduct studies over the next

> three

> years of patients who have suffered severe liver injury because of both

> prescription and " over-the-counter medications, " nutritional supplements,

> alternative medicines and herbals. The DILIN centers are located in North

> Carolina, Indiana, San Francisco, Michigan, and Connecticut, and will be

> awarded

> $2.25 million per year.

>

> One objective of DILIN is to develop standardized definitions and

> instruments to

> identify and fully characterize cases of drug-induced liver injury. With a

> systematic way of classifying drug-induced liver injury, researchers will

> be

>

> able to analyze the epidemiology and clinical issues of liver injury and

> collect

> biological samples that can be used to study the causes of liver toxicity

> using

> biochemical, serological, and genetic testing. The DILIN is sponsored by

> the

>

> National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),

> one of

> the institutes of the NIH.

>

> Another objective of DILIN is to establish a registry of patients who have

> experienced severe drug induced liver injury. " Part of the difficulty in

> studying drug-induced liver disease is the absence of a sufficient cohort

> of

>

> well-characterized patients in whom to carry out clinical, genetic,

> immunological and biochemical investigation, " says Serrano, M.D.,

> Ph.D,

>

> director, NIDDKs' Liver and Biliary Diseases Program and coordinator of

> the

> DILIN. " DILIN will help to eliminate this barrier and advance the

> understanding

> of drug-induced liver injury forward, " he adds.

>

> Drug-induced liver injury occurs in all age groups, but most cases occur

> within

> the elderly population because they take more medications than younger

> persons

> and also use multiple medications. Furthermore, drug-induced liver injury

> is

> the

> most common reason why drugs are not approved by the Food and Drug

> Administration (FDA) or are removed from the market after they have been

> approved.

>

> Most drugs that can cause liver injury are entirely safe for the majority

> of

>

> patients taking them. The reason why some patients are susceptible to

> liver

> injury from a drug is rarely known. " It is likely a result of many

> interrelated

> factors that involve complex interactions between our genes and the

> environment, " says Jay Hoofnagle, M.D., director, NIDDK Liver Diseases

> Research

> Branch. " Liver injury is unpredictable and variable in clinical

> presentation,

> making causality very tough to assess, " explains Hoofnagle.

>

> At present, DILIN has developed protocols for both retrospective and

> prospective

> studies of drug-induced liver disease. The retrospective study will

> establish a

> registry of patients who have taken one of four specific drugs since 1994

> and

> developed liver injury later.

>

> The four drugs are isoniazid, phenytoin, valproic acid, and clavulanic

> acid/amoxicillin. These drugs were chosen because they are widely

> prescribed

> and

> have definite clinical presentation. A minimum of 50 cases of each form of

> drug-

> induced liver disease will be collected along with an equal number of

> patients

> who have taken the drugs safely (controls). The researchers will obtain

> clinical

> and DNA information from each patient.

>

> The prospective study will focus on enrolling patients who recently

> suffered

> an

> adverse liver reaction after taking any drug or herbal medicine. These

> patients

> will be followed over time to find out what happens to them as a result of

> their

> injury. Patients who have not sustained liver injury, but who have taken

> any

> of

> the drugs in question, will also be enrolled in the prospective study.

>

> " Overall, we believe that the DILIN will bring greater focus and interest

> to

> the

> study of drug-induced liver injury and help to develop better ways to

> prevent,

> detect, and treat this growing liver problem, " says Watkins, M.D.,

> chair,

> the DILIN Steering Committee and principal investigator for the center in

> North

> Carolina.

>

> The DILIN researchers have also developed diagnostic criteria and measures

> for

> grading causality in patients with drug-induced liver disease and will

> prospectively assess these instruments for sensitivity and specificity.

> Patient

> enrollment is ongoing.

>

> The DILIN consists of the following principal investigators and centers:

>

> Dr. Watkins, University of North Carolina, Chapel Hill, North

> Carolina

>

> Dr. Naga Chalasani, University of Indiana, Indianapolis, Indiana

>

> Dr. Davern, University of California, San Francisco, California

>

> Dr. Fontana, University of Michigan, Ann Arbor, Michigan

>

> Dr. Herbert Bonkovsky, University of Connecticut, Hartford, Connecticut

>

> Dr. Rochon, ( " Data Coordinating Center " ), Duke University,

> Raleigh-Durham,

> North Carolina

>

> For more information, contact Curtis or Marcia Vital at the NIDDK

> Information Office (301-496-3583).

>

> The National Institute of Diabetes and Digestive and Kidney Diseases

> (NIDDK)

> is

> a component of the National Institutes of Health (NIH), U.S. Department of

> Health and Human Services (DHHS). NIDDK supports a significant amount of

> the

>

> Federal Government's research on endocrine and metabolic diseases such as

> diabetes and obesity, digestive diseases such as hepatitis and

> inflammatory

> bowel disease, kidney and urologic diseases such as kidney failure and

> prostate

> enlargement, and blood diseases such as the anemias. The Institute carries

> out a

> large variety of research initiatives and programs that will bring new

> knowledge

> into proven therapies that benefit the public. Health information and

> additional

> information about NIDDK can be found on the NIDDK home page at:

>

> ##

>

> This NIH News Release is available online at:

> http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

>

> To subscribe (or unsubscribe) from this list, go to

>

November 20, 2004

> U.S. Department of Health and Human Services

>

> NATIONAL INSTITUTES OF HEALTH

>

> NIH News

>

> National Institute of Diabetes and

> Digestive and Kidney Diseases (NIDDK)

>

> FOR IMMEDIATE RELEASE

> Friday, November 19, 2004

>

> CONTACTS:

> Curtis

> or Marcia Vital,

> 301- 496-3583

>

> THE NIH FUNDS NETWORK TO STUDY DRUG-INDUCED LIVER INJURY (DILIN)

>

> The National Institutes of Health (NIH) has launched a network of five

> clinical

> centers and a data coordinating center to conduct studies over the next

> three

> years of patients who have suffered severe liver injury because of both

> prescription and " over-the-counter medications, " nutritional supplements,

> alternative medicines and herbals. The DILIN centers are located in North

> Carolina, Indiana, San Francisco, Michigan, and Connecticut, and will be

> awarded

> $2.25 million per year.

>

> One objective of DILIN is to develop standardized definitions and

> instruments to

> identify and fully characterize cases of drug-induced liver injury. With a

> systematic way of classifying drug-induced liver injury, researchers will

> be

>

> able to analyze the epidemiology and clinical issues of liver injury and

> collect

> biological samples that can be used to study the causes of liver toxicity

> using

> biochemical, serological, and genetic testing. The DILIN is sponsored by

> the

>

> National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),

> one of

> the institutes of the NIH.

>

> Another objective of DILIN is to establish a registry of patients who have

> experienced severe drug induced liver injury. " Part of the difficulty in

> studying drug-induced liver disease is the absence of a sufficient cohort

> of

>

> well-characterized patients in whom to carry out clinical, genetic,

> immunological and biochemical investigation, " says Serrano, M.D.,

> Ph.D,

>

> director, NIDDKs' Liver and Biliary Diseases Program and coordinator of

> the

> DILIN. " DILIN will help to eliminate this barrier and advance the

> understanding

> of drug-induced liver injury forward, " he adds.

>

> Drug-induced liver injury occurs in all age groups, but most cases occur

> within

> the elderly population because they take more medications than younger

> persons

> and also use multiple medications. Furthermore, drug-induced liver injury

> is

> the

> most common reason why drugs are not approved by the Food and Drug

> Administration (FDA) or are removed from the market after they have been

> approved.

>

> Most drugs that can cause liver injury are entirely safe for the majority

> of

>

> patients taking them. The reason why some patients are susceptible to

> liver

> injury from a drug is rarely known. " It is likely a result of many

> interrelated

> factors that involve complex interactions between our genes and the

> environment, " says Jay Hoofnagle, M.D., director, NIDDK Liver Diseases

> Research

> Branch. " Liver injury is unpredictable and variable in clinical

> presentation,

> making causality very tough to assess, " explains Hoofnagle.

>

> At present, DILIN has developed protocols for both retrospective and

> prospective

> studies of drug-induced liver disease. The retrospective study will

> establish a

> registry of patients who have taken one of four specific drugs since 1994

> and

> developed liver injury later.

>

> The four drugs are isoniazid, phenytoin, valproic acid, and clavulanic

> acid/amoxicillin. These drugs were chosen because they are widely

> prescribed

> and

> have definite clinical presentation. A minimum of 50 cases of each form of

> drug-

> induced liver disease will be collected along with an equal number of

> patients

> who have taken the drugs safely (controls). The researchers will obtain

> clinical

> and DNA information from each patient.

>

> The prospective study will focus on enrolling patients who recently

> suffered

> an

> adverse liver reaction after taking any drug or herbal medicine. These

> patients

> will be followed over time to find out what happens to them as a result of

> their

> injury. Patients who have not sustained liver injury, but who have taken

> any

> of

> the drugs in question, will also be enrolled in the prospective study.

>

> " Overall, we believe that the DILIN will bring greater focus and interest

> to

> the

> study of drug-induced liver injury and help to develop better ways to

> prevent,

> detect, and treat this growing liver problem, " says Watkins, M.D.,

> chair,

> the DILIN Steering Committee and principal investigator for the center in

> North

> Carolina.

>

> The DILIN researchers have also developed diagnostic criteria and measures

> for

> grading causality in patients with drug-induced liver disease and will

> prospectively assess these instruments for sensitivity and specificity.

> Patient

> enrollment is ongoing.

>

> The DILIN consists of the following principal investigators and centers:

>

> Dr. Watkins, University of North Carolina, Chapel Hill, North

> Carolina

>

> Dr. Naga Chalasani, University of Indiana, Indianapolis, Indiana

>

> Dr. Davern, University of California, San Francisco, California

>

> Dr. Fontana, University of Michigan, Ann Arbor, Michigan

>

> Dr. Herbert Bonkovsky, University of Connecticut, Hartford, Connecticut

>

> Dr. Rochon, ( " Data Coordinating Center " ), Duke University,

> Raleigh-Durham,

> North Carolina

>

> For more information, contact Curtis or Marcia Vital at the NIDDK

> Information Office (301-496-3583).

>

> The National Institute of Diabetes and Digestive and Kidney Diseases

> (NIDDK)

> is

> a component of the National Institutes of Health (NIH), U.S. Department of

> Health and Human Services (DHHS). NIDDK supports a significant amount of

> the

>

> Federal Government's research on endocrine and metabolic diseases such as

> diabetes and obesity, digestive diseases such as hepatitis and

> inflammatory

> bowel disease, kidney and urologic diseases such as kidney failure and

> prostate

> enlargement, and blood diseases such as the anemias. The Institute carries

> out a

> large variety of research initiatives and programs that will bring new

> knowledge

> into proven therapies that benefit the public. Health information and

> additional

> information about NIDDK can be found on the NIDDK home page at:

>

> ##

>

> This NIH News Release is available online at:

> http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

>

> To subscribe (or unsubscribe) from this list, go to

>

November 20, 2004

> U.S. Department of Health and Human Services

>

> NATIONAL INSTITUTES OF HEALTH

>

> NIH News

>

> National Institute of Diabetes and

> Digestive and Kidney Diseases (NIDDK)

>

> FOR IMMEDIATE RELEASE

> Friday, November 19, 2004

>

> CONTACTS:

> Curtis

> or Marcia Vital,

> 301- 496-3583

>

> THE NIH FUNDS NETWORK TO STUDY DRUG-INDUCED LIVER INJURY (DILIN)

>

> The National Institutes of Health (NIH) has launched a network of five

> clinical

> centers and a data coordinating center to conduct studies over the next

> three

> years of patients who have suffered severe liver injury because of both

> prescription and " over-the-counter medications, " nutritional supplements,

> alternative medicines and herbals. The DILIN centers are located in North

> Carolina, Indiana, San Francisco, Michigan, and Connecticut, and will be

> awarded

> $2.25 million per year.

>

> One objective of DILIN is to develop standardized definitions and

> instruments to

> identify and fully characterize cases of drug-induced liver injury. With a

> systematic way of classifying drug-induced liver injury, researchers will

> be

>

> able to analyze the epidemiology and clinical issues of liver injury and

> collect

> biological samples that can be used to study the causes of liver toxicity

> using

> biochemical, serological, and genetic testing. The DILIN is sponsored by

> the

>

> National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),

> one of

> the institutes of the NIH.

>

> Another objective of DILIN is to establish a registry of patients who have

> experienced severe drug induced liver injury. " Part of the difficulty in

> studying drug-induced liver disease is the absence of a sufficient cohort

> of

>

> well-characterized patients in whom to carry out clinical, genetic,

> immunological and biochemical investigation, " says Serrano, M.D.,

> Ph.D,

>

> director, NIDDKs' Liver and Biliary Diseases Program and coordinator of

> the

> DILIN. " DILIN will help to eliminate this barrier and advance the

> understanding

> of drug-induced liver injury forward, " he adds.

>

> Drug-induced liver injury occurs in all age groups, but most cases occur

> within

> the elderly population because they take more medications than younger

> persons

> and also use multiple medications. Furthermore, drug-induced liver injury

> is

> the

> most common reason why drugs are not approved by the Food and Drug

> Administration (FDA) or are removed from the market after they have been

> approved.

>

> Most drugs that can cause liver injury are entirely safe for the majority

> of

>

> patients taking them. The reason why some patients are susceptible to

> liver

> injury from a drug is rarely known. " It is likely a result of many

> interrelated

> factors that involve complex interactions between our genes and the

> environment, " says Jay Hoofnagle, M.D., director, NIDDK Liver Diseases

> Research

> Branch. " Liver injury is unpredictable and variable in clinical

> presentation,

> making causality very tough to assess, " explains Hoofnagle.

>

> At present, DILIN has developed protocols for both retrospective and

> prospective

> studies of drug-induced liver disease. The retrospective study will

> establish a

> registry of patients who have taken one of four specific drugs since 1994

> and

> developed liver injury later.

>

> The four drugs are isoniazid, phenytoin, valproic acid, and clavulanic

> acid/amoxicillin. These drugs were chosen because they are widely

> prescribed

> and

> have definite clinical presentation. A minimum of 50 cases of each form of

> drug-

> induced liver disease will be collected along with an equal number of

> patients

> who have taken the drugs safely (controls). The researchers will obtain

> clinical

> and DNA information from each patient.

>

> The prospective study will focus on enrolling patients who recently

> suffered

> an

> adverse liver reaction after taking any drug or herbal medicine. These

> patients

> will be followed over time to find out what happens to them as a result of

> their

> injury. Patients who have not sustained liver injury, but who have taken

> any

> of

> the drugs in question, will also be enrolled in the prospective study.

>

> " Overall, we believe that the DILIN will bring greater focus and interest

> to

> the

> study of drug-induced liver injury and help to develop better ways to

> prevent,

> detect, and treat this growing liver problem, " says Watkins, M.D.,

> chair,

> the DILIN Steering Committee and principal investigator for the center in

> North

> Carolina.

>

> The DILIN researchers have also developed diagnostic criteria and measures

> for

> grading causality in patients with drug-induced liver disease and will

> prospectively assess these instruments for sensitivity and specificity.

> Patient

> enrollment is ongoing.

>

> The DILIN consists of the following principal investigators and centers:

>

> Dr. Watkins, University of North Carolina, Chapel Hill, North

> Carolina

>

> Dr. Naga Chalasani, University of Indiana, Indianapolis, Indiana

>

> Dr. Davern, University of California, San Francisco, California

>

> Dr. Fontana, University of Michigan, Ann Arbor, Michigan

>

> Dr. Herbert Bonkovsky, University of Connecticut, Hartford, Connecticut

>

> Dr. Rochon, ( " Data Coordinating Center " ), Duke University,

> Raleigh-Durham,

> North Carolina

>

> For more information, contact Curtis or Marcia Vital at the NIDDK

> Information Office (301-496-3583).

>

> The National Institute of Diabetes and Digestive and Kidney Diseases

> (NIDDK)

> is

> a component of the National Institutes of Health (NIH), U.S. Department of

> Health and Human Services (DHHS). NIDDK supports a significant amount of

> the

>

> Federal Government's research on endocrine and metabolic diseases such as

> diabetes and obesity, digestive diseases such as hepatitis and

> inflammatory

> bowel disease, kidney and urologic diseases such as kidney failure and

> prostate

> enlargement, and blood diseases such as the anemias. The Institute carries

> out a

> large variety of research initiatives and programs that will bring new

> knowledge

> into proven therapies that benefit the public. Health information and

> additional

> information about NIDDK can be found on the NIDDK home page at:

>

> ##

>

> This NIH News Release is available online at: