July 10, 2003 - UPI: FDA orders Lariam warning
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FDA orders Lariam warning




Read and comment on this story from UPI that the Food and Drug Administration has taken the rare step of ordering that patients are warned directly of serious mental problems and reports of suicide linked to a common anti-malaria drug called Lariam. For more than a decade, Peace Corps volunteers and U.S. travelers given Lariam have complained of frightening episodes of hallucinations, delusions and suicidal thoughts. Read the story at:

Malaria drug warning follows problems*

* This link was active on the date it was posted. PCOL is not responsible for broken links which may have changed.


Malaria drug warning follows problems

By Mark Benjamin and Dan Olmsted
Published 7/10/2003 4:09 PM
View printer-friendly version

WASHINGTON, July 10 (UPI) -- The Food and Drug Administration has taken the rare step of ordering that patients are warned directly of serious mental problems and reports of suicide linked to a common anti-malaria drug called Lariam.

The move -- which the FDA has ordered only 17 times previously -- follows a decade of increasingly dire warnings about the drug, and a trail of horror stories from people who said they have suffered from side effects from the drug.

Lariam hit the news last summer after three Fort Bragg, N.C., soldiers accused of killing their wives after returning from Afghanistan appeared to have taken the drug. Two of the three shot themselves after killing their wives; the third hanged himself in his jail cell in March. A U.S. Army report said the drug was an "unlikely" factor for the cluster of deaths but did not rule it out in any one case.

The FDA on Wednesday required by law that all doctors hand patients a "medication guide" with the new Lariam warnings. It is the 18th time the FDA has made the aggressive move.

The new warnings say the drug has been associated with "serious psychiatric adverse events" that "may persist even after stopping the medication." It also notes "rare reports have claimed that Lariam users think about killing themselves" and "rarer reports of suicides."

The FDA says the guides are used for drugs "that pose a serious and significant public health concern."

"The Lariam Medication Guide is an important new tool for managing the risks of Lariam, one of the most highly effective means of combating one of the deadliest diseases in the world," FDA Commissioner Mark B. McClellan said.

Lariam's manufacturer, Roche Pharmaceuticals of Nutley, N.J., is also sending letters to U.S. doctors and pharmacists about the new guide.

Critics said the FDA move is late. "This is probably long overdue," said Larry Sasich, of Public Citizen, a government and business watchdog group. "This information should have been in people's hands years ago."

The FDA also requires that doctors hand out a medication guide warning of possible suicide risk for another Roche drug, Accutane, which is used to treat serious cases of acne.

With Lariam, Roche in May 2002 settled a lawsuit brought by an Ohio woman who claimed her husband had committed suicide after taking the drug. The terms were not disclosed.

For more than a decade, Peace Corps volunteers and U.S. travelers given Lariam have complained of frightening episodes of hallucinations, delusions and suicidal thoughts. Starting in Somalia in the early 1990s, soldiers from a series of deployments have told similar stories about the drug, saying it has also caused sudden, uncontrollable rage and homicidal urges.

Roche has placed increasingly serious warnings on the Lariam's product label, read by doctors and pharmacists, since the FDA approved it in 1989. It added in 1999 that, "Suicidal ideation has also rarely been reported, but no relationship to drug administration has been established."

Last July, the FDA updated Lariam's official product label warning of "anxiety, paranoia and depression" and "hallucinations and psychotic behavior" that "have been reported to continue long after (Lariam) has been stopped." It also said that, "Rare cases of suicidal ideation (thinking) and suicide have been reported though no relationship to drug administration has been confirmed."

Roche last September sent a letter to 120,000 doctors about those label changes.

Following the string of events at Fort Bragg last summer, the drug company told United Press International that malaria is a dangerous disease and that, "It is important to note that Lariam is not associated with violent, criminal conduct."

The FDA told UPI last September that suicide might have to be tolerated because malaria is such a deadly disease. "Suicide in one in perhaps -- I don't know -- 1 million or however many cases you can actually calculate for Lariam may have to be acceptable on the basis for the risk for malaria," said Dr. Leonard Sacks, a medical officer with the FDA.
Copyright © 2001-2003 United Press International
More about Lariam



Read more about Lariam in these other stories we have published on PCOL at:

Click on a link below for more stories on PCOL

7/10/03
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This Month's Issue

A Volunteer's Courage

After Sara Evans was assaulted she left the Peace Corps and returned to the United States. But her ordeal was only beginning. Read about a volunteer's courage in this story.
July Issue: A Volunteer's Courage
A Volunteer's Courage: Health Care for RPCVs
Issues with the Peace Corps Bill in Congress
Americorps' Failure: Lessons for the Peace Corps
RPCVs dump ton of coal at US Capital
German Peace Corps celebrates 40 years
Bill Moyers talks about America’s Future

More Feature Stories
Protest at the Peace Corps
Returned Volunteers honor Jack Vaughn
Alcohol Abuse a big issue for PCVs in Central Asia
Peace Corps to add 1,000 AIDS/HIV volunteers
Op-ed: The Future of the Peace Corps
Marine Sergeant says PC is "truly hardcore"
RPCV is wheelchair basketball champion
Watch Director Vasquez on web tv
Presidential Candidate calls for 25,000 Volunteers
Top Stories and Breaking News
Volunteer Zack Merrill dies in Mali 8 July
Friends of Liberia issue call to action 8 July
Call Congress about Peace Corps Funding 5 July
PCV says Bush to visit Goree Island 4 July
RPCV gives the Indian River a voice 2 July
RPCV Donna Shalala wins at football 2 July
Election Results in for NPCA Board 1 July
Tony Gasbarro honored with Carter Award 1 July
The Shrivers: A Special Legacy 30 June
Malian President Touré Speaks at PC HQ 26 June
NGOs feel the squeeze from USAID 25 June
NPCA to announce President in July 19 June
A PCV reports on Mauritania coup attempt 15 June
Peace Corps Bill passes House Committee 12 June
Bridgeland on "Volunteers for Prosperity" 9 June
PC announces Franklin H. Williams Awards 4 June

Previous Issues and Special Reports
Exclusive: How RPCVs organized anti-war Ad
Improvements needed in Volunteer Support
From Russia with Love
Health Concerns: The Controversy over Lariam
GAO Reports on PCV Safety and Security
The Digital Freedom Initiative
PC/Washington: Senior Staff Appointments at PC HQ
PC Expansion: The Numbers Game?
Op-ed: Why Peace Corps needs Shriver's 4th Goal
When should PC return to Afghanistan?
RPCV Spy dies in Moscow
Op-ed: The Case for Peace Corps Independence
Preservation of an Independent Peace Corps
For the Peace Corps Fallen


Some postings on Peace Corps Online are provided to the individual members of this group without permission of the copyright owner for the non-profit purposes of criticism, comment, education, scholarship, and research under the "Fair Use" provisions of U.S. Government copyright laws and they may not be distributed further without permission of the copyright owner. Peace Corps Online does not vouch for the accuracy of the content of the postings, which is the sole responsibility of the copyright holder.

This story has been posted in the following forums: : Headlines; Safety and Security of Volunteers; Lariam

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By Admin1 (admin) on Friday, July 11, 2003 - 10:13 am: Edit Post

FDA orders Lariam warning




Read and comment on this story from UPI that the Food and Drug Administration has taken the rare step of ordering that patients are warned directly of serious mental problems and reports of suicide linked to a common anti-malaria drug called Lariam. For more than a decade, Peace Corps volunteers and U.S. travelers given Lariam have complained of frightening episodes of hallucinations, delusions and suicidal thoughts. Read the story at:

Malaria drug warning follows problems*

* This link was active on the date it was posted. PCOL is not responsible for broken links which may have changed.


Malaria drug warning follows problems

By Mark Benjamin and Dan Olmsted
Published 7/10/2003 4:09 PM
View printer-friendly version

WASHINGTON, July 10 (UPI) -- The Food and Drug Administration has taken the rare step of ordering that patients are warned directly of serious mental problems and reports of suicide linked to a common anti-malaria drug called Lariam.

The move -- which the FDA has ordered only 17 times previously -- follows a decade of increasingly dire warnings about the drug, and a trail of horror stories from people who said they have suffered from side effects from the drug.

Lariam hit the news last summer after three Fort Bragg, N.C., soldiers accused of killing their wives after returning from Afghanistan appeared to have taken the drug. Two of the three shot themselves after killing their wives; the third hanged himself in his jail cell in March. A U.S. Army report said the drug was an "unlikely" factor for the cluster of deaths but did not rule it out in any one case.

The FDA on Wednesday required by law that all doctors hand patients a "medication guide" with the new Lariam warnings. It is the 18th time the FDA has made the aggressive move.

The new warnings say the drug has been associated with "serious psychiatric adverse events" that "may persist even after stopping the medication." It also notes "rare reports have claimed that Lariam users think about killing themselves" and "rarer reports of suicides."

The FDA says the guides are used for drugs "that pose a serious and significant public health concern."

"The Lariam Medication Guide is an important new tool for managing the risks of Lariam, one of the most highly effective means of combating one of the deadliest diseases in the world," FDA Commissioner Mark B. McClellan said.

Lariam's manufacturer, Roche Pharmaceuticals of Nutley, N.J., is also sending letters to U.S. doctors and pharmacists about the new guide.

Critics said the FDA move is late. "This is probably long overdue," said Larry Sasich, of Public Citizen, a government and business watchdog group. "This information should have been in people's hands years ago."

The FDA also requires that doctors hand out a medication guide warning of possible suicide risk for another Roche drug, Accutane, which is used to treat serious cases of acne.

With Lariam, Roche in May 2002 settled a lawsuit brought by an Ohio woman who claimed her husband had committed suicide after taking the drug. The terms were not disclosed.

For more than a decade, Peace Corps volunteers and U.S. travelers given Lariam have complained of frightening episodes of hallucinations, delusions and suicidal thoughts. Starting in Somalia in the early 1990s, soldiers from a series of deployments have told similar stories about the drug, saying it has also caused sudden, uncontrollable rage and homicidal urges.

Roche has placed increasingly serious warnings on the Lariam's product label, read by doctors and pharmacists, since the FDA approved it in 1989. It added in 1999 that, "Suicidal ideation has also rarely been reported, but no relationship to drug administration has been established."

Last July, the FDA updated Lariam's official product label warning of "anxiety, paranoia and depression" and "hallucinations and psychotic behavior" that "have been reported to continue long after (Lariam) has been stopped." It also said that, "Rare cases of suicidal ideation (thinking) and suicide have been reported though no relationship to drug administration has been confirmed."

Roche last September sent a letter to 120,000 doctors about those label changes.

Following the string of events at Fort Bragg last summer, the drug company told United Press International that malaria is a dangerous disease and that, "It is important to note that Lariam is not associated with violent, criminal conduct."

The FDA told UPI last September that suicide might have to be tolerated because malaria is such a deadly disease. "Suicide in one in perhaps -- I don't know -- 1 million or however many cases you can actually calculate for Lariam may have to be acceptable on the basis for the risk for malaria," said Dr. Leonard Sacks, a medical officer with the FDA.
Copyright © 2001-2003 United Press International
More about Lariam



Read more about Lariam in these other stories we have published on PCOL at:

Click on a link below for more stories on PCOL

7/10/03
Main Sections
PCOL Magazine
Breaking News
One World
Peace Corps Library

What's New?

Contact PCOL

Sign Up for Newsletter

Sign Up for Directory

RPCV Directory
RPCVs by COS
RPCVs by State
RPCVs by Interest

Special Sections
Advocacy
Bulletin Board
Cartoons
Congress
Directors
Downloads
Headlines
History
Humor
Laws
Local RPCV Groups
Lost RPCVs
Master Index
NPCA
Obituaries
PCVs
Photography
RPCVs
Recruitment
Return to COS
Safety of PCVs
Service
Speaking Out
States
Stories
The Third Goal
Training
US Peace Corps
USA Freedom Corps
Writing
This Month's Issue

A Volunteer's Courage

After Sara Evans was assaulted she left the Peace Corps and returned to the United States. But her ordeal was only beginning. Read about a volunteer's courage in this story.
July Issue: A Volunteer's Courage
A Volunteer's Courage: Health Care for RPCVs
Issues with the Peace Corps Bill in Congress
Americorps' Failure: Lessons for the Peace Corps
RPCVs dump ton of coal at US Capital
German Peace Corps celebrates 40 years
Bill Moyers talks about America’s Future

More Feature Stories
Protest at the Peace Corps
Returned Volunteers honor Jack Vaughn
Alcohol Abuse a big issue for PCVs in Central Asia
Peace Corps to add 1,000 AIDS/HIV volunteers
Op-ed: The Future of the Peace Corps
Marine Sergeant says PC is "truly hardcore"
RPCV is wheelchair basketball champion
Watch Director Vasquez on web tv
Presidential Candidate calls for 25,000 Volunteers
Top Stories and Breaking News
Volunteer Zack Merrill dies in Mali 8 July
Friends of Liberia issue call to action 8 July
Call Congress about Peace Corps Funding 5 July
PCV says Bush to visit Goree Island 4 July
RPCV gives the Indian River a voice 2 July
RPCV Donna Shalala wins at football 2 July
Election Results in for NPCA Board 1 July
Tony Gasbarro honored with Carter Award 1 July
The Shrivers: A Special Legacy 30 June
Malian President Touré Speaks at PC HQ 26 June
NGOs feel the squeeze from USAID 25 June
NPCA to announce President in July 19 June
A PCV reports on Mauritania coup attempt 15 June
Peace Corps Bill passes House Committee 12 June
Bridgeland on "Volunteers for Prosperity" 9 June
PC announces Franklin H. Williams Awards 4 June

Previous Issues and Special Reports
Exclusive: How RPCVs organized anti-war Ad
Improvements needed in Volunteer Support
From Russia with Love
Health Concerns: The Controversy over Lariam
GAO Reports on PCV Safety and Security
The Digital Freedom Initiative
PC/Washington: Senior Staff Appointments at PC HQ
PC Expansion: The Numbers Game?
Op-ed: Why Peace Corps needs Shriver's 4th Goal
When should PC return to Afghanistan?
RPCV Spy dies in Moscow
Op-ed: The Case for Peace Corps Independence
Preservation of an Independent Peace Corps
For the Peace Corps Fallen


Some postings on Peace Corps Online are provided to the individual members of this group without permission of the copyright owner for the non-profit purposes of criticism, comment, education, scholarship, and research under the "Fair Use" provisions of U.S. Government copyright laws and they may not be distributed further without permission of the copyright owner. Peace Corps Online does not vouch for the accuracy of the content of the postings, which is the sole responsibility of the copyright holder.

This story has been posted in the following forums: : Headlines; Safety and Security of Volunteers; Lariam

PCOL6692
78

.

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