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ACE inhibitor ramipril (Altace) associated with rare cases of hepatic failure

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CLINICAL CARE OPTIONS FOR HEPATITIS

http://clinicaloptions.com/hep/news/news_imed_358.asp

DRUG ALERT: ACE inhibitor ramipril (Altace) associated with rare cases of

hepatic failure

By Jillian L Lokere, MS

March 3, 2005 - In November 2004, the labeling of the angiotensin-converting

enzyme (ACE) inhibitor ramipril (Altace) was changed to include a warning

that, in rare cases, ACE inhibitors have been associated with fulminant

hepatic necrosis. The new warning, issued by the United States Food and Drug

Administration and King Pharmaceuticals, Inc., advises that patients taking

ramipril who develop jaundice or marked elevations of hepatic enzymes should

discontinue the medication and receive appropriate medical follow-up.

Ramipril is an antihypertenisve medication used to reduce the risk of

myocardial infarction, stroke, and death from cardiovascular causes in

high-risk patients aged 55 years or older. The medication is also indicated

for use in stable patients with clinical signs of congestive heart failure

after acute myocardial infarction.

In a clinical trial of 1004 patients treated with ramipril, fewer than 1% of

patients displayed a syndrome that started with cholestatic jaundice and

progressed to fulminant hepatic necrosis and occasionally death. The

mechanism of this syndrome is not understood.

To report adverse events associated with the use of ramipril, physicians can

call King Pharmaceuticals Drug Safety and Pharmacovigilance department at

1-800-546-4905. For questions regarding the use of ramipril, physicians can

contact King Pharmaceuticals Professional Information Services at

1-800-776-3637.

Reference

FDA Medwatch warning: http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

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CLINICAL CARE OPTIONS FOR HEPATITIS

http://clinicaloptions.com/hep/news/news_imed_358.asp

DRUG ALERT: ACE inhibitor ramipril (Altace) associated with rare cases of

hepatic failure

By Jillian L Lokere, MS

March 3, 2005 - In November 2004, the labeling of the angiotensin-converting

enzyme (ACE) inhibitor ramipril (Altace) was changed to include a warning

that, in rare cases, ACE inhibitors have been associated with fulminant

hepatic necrosis. The new warning, issued by the United States Food and Drug

Administration and King Pharmaceuticals, Inc., advises that patients taking

ramipril who develop jaundice or marked elevations of hepatic enzymes should

discontinue the medication and receive appropriate medical follow-up.

Ramipril is an antihypertenisve medication used to reduce the risk of

myocardial infarction, stroke, and death from cardiovascular causes in

high-risk patients aged 55 years or older. The medication is also indicated

for use in stable patients with clinical signs of congestive heart failure

after acute myocardial infarction.

In a clinical trial of 1004 patients treated with ramipril, fewer than 1% of

patients displayed a syndrome that started with cholestatic jaundice and

progressed to fulminant hepatic necrosis and occasionally death. The

mechanism of this syndrome is not understood.

To report adverse events associated with the use of ramipril, physicians can

call King Pharmaceuticals Drug Safety and Pharmacovigilance department at

1-800-546-4905. For questions regarding the use of ramipril, physicians can

contact King Pharmaceuticals Professional Information Services at

1-800-776-3637.

Reference

FDA Medwatch warning: http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

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CLINICAL CARE OPTIONS FOR HEPATITIS

http://clinicaloptions.com/hep/news/news_imed_358.asp

DRUG ALERT: ACE inhibitor ramipril (Altace) associated with rare cases of

hepatic failure

By Jillian L Lokere, MS

March 3, 2005 - In November 2004, the labeling of the angiotensin-converting

enzyme (ACE) inhibitor ramipril (Altace) was changed to include a warning

that, in rare cases, ACE inhibitors have been associated with fulminant

hepatic necrosis. The new warning, issued by the United States Food and Drug

Administration and King Pharmaceuticals, Inc., advises that patients taking

ramipril who develop jaundice or marked elevations of hepatic enzymes should

discontinue the medication and receive appropriate medical follow-up.

Ramipril is an antihypertenisve medication used to reduce the risk of

myocardial infarction, stroke, and death from cardiovascular causes in

high-risk patients aged 55 years or older. The medication is also indicated

for use in stable patients with clinical signs of congestive heart failure

after acute myocardial infarction.

In a clinical trial of 1004 patients treated with ramipril, fewer than 1% of

patients displayed a syndrome that started with cholestatic jaundice and

progressed to fulminant hepatic necrosis and occasionally death. The

mechanism of this syndrome is not understood.

To report adverse events associated with the use of ramipril, physicians can

call King Pharmaceuticals Drug Safety and Pharmacovigilance department at

1-800-546-4905. For questions regarding the use of ramipril, physicians can

contact King Pharmaceuticals Professional Information Services at

1-800-776-3637.

Reference

FDA Medwatch warning: http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

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CLINICAL CARE OPTIONS FOR HEPATITIS

http://clinicaloptions.com/hep/news/news_imed_358.asp

DRUG ALERT: ACE inhibitor ramipril (Altace) associated with rare cases of

hepatic failure

By Jillian L Lokere, MS

March 3, 2005 - In November 2004, the labeling of the angiotensin-converting

enzyme (ACE) inhibitor ramipril (Altace) was changed to include a warning

that, in rare cases, ACE inhibitors have been associated with fulminant

hepatic necrosis. The new warning, issued by the United States Food and Drug

Administration and King Pharmaceuticals, Inc., advises that patients taking

ramipril who develop jaundice or marked elevations of hepatic enzymes should

discontinue the medication and receive appropriate medical follow-up.

Ramipril is an antihypertenisve medication used to reduce the risk of

myocardial infarction, stroke, and death from cardiovascular causes in

high-risk patients aged 55 years or older. The medication is also indicated

for use in stable patients with clinical signs of congestive heart failure

after acute myocardial infarction.

In a clinical trial of 1004 patients treated with ramipril, fewer than 1% of

patients displayed a syndrome that started with cholestatic jaundice and

progressed to fulminant hepatic necrosis and occasionally death. The

mechanism of this syndrome is not understood.

To report adverse events associated with the use of ramipril, physicians can

call King Pharmaceuticals Drug Safety and Pharmacovigilance department at

1-800-546-4905. For questions regarding the use of ramipril, physicians can

contact King Pharmaceuticals Professional Information Services at

1-800-776-3637.

Reference

FDA Medwatch warning: http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

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