Military Asked To Review Lariam

Military Asked To Review Lariam
United Press International
November 5, 2003


WASHINGTON - Sen. Dianne Feinstein wants the U.S. military to reassess its use of the anti malaria drug Lariam, prescribed to some troops in Iraq, because of what she calls "growing evidence about Lariam's dangerous side effects" and complaints by troops that it has damaged their health.

"Given the mounting concerns about Lariam as expressed by civilians, service members and medical experts about its known serious side effects, I strongly urge you to reassess the (Department of Defense) policy on the use of Lariam," the California Democrat wrote Defense Secretary Donald Rumsfeld in a letter dated Oct. 29.

In the short term, Feinstein said, the military should "immediately provide service members with information about Lariam's potential side effects," more closely monitor troops for problems and offer easy access to alternatives.

The Pentagon declined to comment on the letter. In the past, military medical officials have said that the drug has proven its worth and hasn't caused serious problems. "Our point of view is Lariam is a very useful medication in preventing a dangerous disease, and our experiences with it have been good," Virginia Stephanakis, a spokeswoman for the Army surgeon general's office, told United Press International earlier this year.

Lariam was developed by the U.S. Army in the 1970s, licensed to Swiss drug giant Hoffmann-La Roche and approved for use in the United States in 1989. The drug label warns of mental and neurological problems in a number of people who take it, including aggression, suicidal thinking, psychosis and depression. In some cases, those effects have been reported to last long after a person stops taking it.

Last year, Roche changed the product label to warn of "rare cases" of suicide, and the Food and Drug Administration has ordered the company to provide detailed written warnings to each person to whom it is prescribed.

Last month, the Pentagon said that nearly 4,000 U.S. troops have been medically evacuated from Operation Iraqi Freedom for non-combat reasons -- with more than one in five of those for psychiatric or neurological problems, according to Pentagon data.

"Clearly there is more detail that needs to be given about the nature and causes of these evacuations," said Steve Robinson, executive director of the National Gulf War Resource Center. "Under psychiatric problems, how many of these could be related to Lariam?"

In her letter, Feinstein raised the possibility that fear of the drug might have led to an outbreak of malaria in more than 100 U.S. troops deployed to Liberia in August.

"While news reports of preliminary interviews with sick soldiers suggest that complacency was the primary factor behind their decision not to take their Lariam pill, I am concerned that first hand experience with its side effects and reports from fellow service members may have played some role in their decision not to take Lariam," Feinstein wrote.

The letter cited the experience of Navy Cmdr. William Manofsky, who volunteered to go to Kuwait as part of Operation Iraqi Freedom last December and began taking Lariam. By the time he returned to California in March, the letter said, "he experienced insomnia, aggression, agitation, rage, mood swings, acute nausea, vomiting, severe anxiety, depression, cognitive disorders and at times difficulty walking and communicating, conditions which placed him in the emergency room five times.

"Unfortunately, doctors have informed Cmdr. Manofsky that some of these conditions may be permanent."

Manofsky was the subject of a Sept. 8 article by United Press International, in which he alleged that the Navy had altered his medical records to remove mention of Lariam. Manofsky provided before-and-after pages from his medical chart that appeared to show that references to the drug were missing. The Navy surgeon general's office said at the time that it was working to resolve the matter. Spokesman Brian Badura did not return a call Monday seeking comment.

Susan Rose, co-director of Lariam Action USA, a group made up of people who believe they have been harmed by the drug, welcomed Feinstein's letter and said: "Contrary to the FDA's assertion that most people can tolerate the drug, scientific studies prove that 1 in 3 will suffer a neuropsychiatric adverse event and 1 in 5 will describe it as moderate to severe."

An Army spokesman told UPI the rate of serious side effects is 1 in 13,000.

Feinstein's letter marks the second time a member of Congress has written Rumsfeld about the drug. In May 2002, Rep. John McHugh, R-N.Y., wrote asking for a review of the military's use of Lariam out of concern that it might cause mental problems among troops.

Assistant Secretary of Defense William Winkenwerder Jr. responded to McHugh that reactions to the drug had been few and generally mild among service members. But he added, "Sufficient evidence exists to raise the question whether the neuropsychiatric adverse events of mefloquine (the generic name for Lariam) are frequent enough and severe enough to warrant limiting its use. However, sufficient evidence does not exist to answer the question, especially in the case of military personnel."

UPI reporters began an investigation of Lariam in early 2002 and found that mounting evidence suggests it has triggered side effects so severe that in a small percentage of users it has led to suicide. UPI also reported that soldiers involved in a string of murder-suicides at Fort Bragg in the summer of 2002 after returning from Afghanistan had taken the drug, and that they exhibited some behavior that matched known side effects.

The Army surgeon general's office dispatched a team to investigate. It reported last November that the drug did not cause the entire cluster of deaths because not everyone suspected in the homicides had taken it, but didn't investigate whether the drug had caused any individual murder-suicide. The report said the only common thread was marital problems, perhaps aggravated by the stress of frequent deployments.

Roche, the manufacturer, says there is no reliable scientific evidence that Lariam can cause violent behavior.

http://www.military.com/NewsContent?..._lariam_110503


Sempers,

Roger
:marine:

November 19, 2003

Senator questions malaria drug’s safety

By Deborah Funk
Times staff writer


A California senator is asking the Defense Department to rethink its use of a particular malaria prevention drug because of reports of psychological problems in some users.
Democratic Sen. Dianne Feinstein wrote to Defense Secretary Donald Rumsfeld asking him to “consider revising the department’s policies” on prescription of Lariam, also known as mefloquine, based on complaints from constituents and “growing evidence” about its “dangerous side effects.”

In the short term, Feinstein wants other anti-malarial drugs, such as Doxycycline and Malarone, given to service members, and wants them to be told of Lariam’s possible side effects. She also asked that troops who receive Lariam be more closely monitored.

Feinstein’s office has heard recently from several troops and federal civilians overseas who have taken Lariam as protection against malaria and say they “suffered significant side effects,” she wrote.

Pentagon officials did not respond to a request for comment on the letter, and referred questions on the use of anti-malarial drugs to the individual services.

Decisions by military commanders on when to use an anti-malarial drug and which to choose depend largely on the threat of malaria in a particular region, and whether the drug is still effective in that area.

In the Navy, combatant commanders and medical staff, weighing the risks and benefits in each case, make decisions.

“All of the anti-malaria drug regimens have minor side effects,” said Navy Lt. John Schofield, a spokesman for Navy medicine. “Considering the effects of malaria, minor side effects are certainly the best of the two options.”

If someone has significant adverse side effects, a different medicine can be used, he said.

Air Force doctors rely on a variety of sources, including the World Health Organization, Centers for Disease Control and Prevention and military medical intelligence, to determine the threat of malaria and the best drug to use for each airman to prevent the disease. Treatment is individualized and a doctor dispenses anti-malarial drugs, the Air Force’s preventive medicine chief said through a spokesman.

The Army also uses a risk-benefit analysis to determine which drug to use to prevent malaria. It has not routinely used Lariam in Iraq, and “very, very few” soldiers are using it there, said Virginia Stephanakis, spokeswoman for the Army Surgeon General. But it is still one of the drugs of choice in areas where falciparum malaria is resistant to chloroquine, another anti-malarial drug. Nausea, vomiting, abdominal pain, headache, insomnia and vivid dreams are the most common side effects of mefloquine, according to Lariam maker Hoffman-LaRoche.

But in an update of its warning label in late 2002, the company advised doctors not to prescribe it to patients with a history of convulsions, depression, or other major psychiatric disorders.

“Rare cases of suicidal ideation and suicide have been reported, though no relationship to drug administration has been confirmed,” the company advised doctors.

http://www.marinecorpstimes.com/stor...25-2411921.php


Sempers,

Roger
:marine:

Issue Date: December 01, 2003

Malaria drug letter cites ‘dangerous side effects’

By Deborah Funk
Times staff writer

A California senator is asking the Defense Department to rethink its use of a particular malaria prevention drug because of reports of psychological problems in some users.
Democratic Sen. Dianne Feinstein wrote to Defense Secretary Donald Rumsfeld asking him to “consider revising the department’s policies” on prescriptions of Lariam, also known as mefloquine, based on complaints from constituents and “growing evidence” about its “dangerous side effects.”

In the short term, Feinstein wants other anti-malarial drugs, such as doxycycline and Malarone, given to service members, and wants them to be told of Lariam’s possible side effects. She also asked that troops who receive Lariam be more closely monitored.

Feinstein’s office has heard from several service members and federal civilians overseas who have taken Lariam as protection against malaria and say they “suffered significant side effects,” she wrote.

Pentagon officials did not respond to a request for comment on the letter and referred questions on the use of anti-malarial drugs to the individual services.

Decisions by military commanders on when to use an anti-malarial drug and which to choose depend largely on the threat of malaria in a particular region and whether the drug still is effective in that area.

Nausea, vomiting, abdominal pain, headache, insomnia and vivid dreams are the most common side effects of mefloquine, according to Lariam maker Hoffman-LaRoche.

But in an update of its warning label in late 2002, the company advised doctors not to prescribe it to patients with a history of convulsions, depression or other major psychiatric disorders.

“Rare cases of suicidal ideation and suicide have been reported, though no relationship to drug administration has been confirmed,” the company advised doctors.

http://www.marinecorpstimes.com/stor...ER-2416693.php


Sempers,

Roger
:marine:

Feinstein to Rumsfeld: Review malaria drug

a whole serious of UPI investgiations on use of drug Larium is at:
http://www.upi.com/lariam.cfm

Feinstein to Rumsfeld: Review malaria drug
By Mark Benjamin and Dan Olmsted
Published 11/5/2003 11:39 AM

WASHINGTON, Nov. 4 (UPI) -- Sen. Dianne Feinstein wants the U.S. military to
reassess its use of the anti-malaria drug Lariam, prescribed to some troops
in Iraq, because of what she calls "growing evidence about Lariam's
dangerous side effects" and complaints by troops that it has damaged their
health.

"Given the mounting concerns about Lariam as expressed by civilians, service
members and medical experts about its known serious side effects, I strongly
urge you to reassess the (Department of Defense) policy on the use of
Lariam," the California Democrat wrote Defense Secretary Donald Rumsfeld in
a letter dated Oct. 29.

In the short term, Feinstein said, the military should "immediately provide
service members with information about Lariam's potential side effects,"
more closely monitor troops for problems and offer easy access to
alternatives.

The Pentagon declined to comment on the letter. In the past, military
medical officials have said that the drug has proven its worth and hasn't
caused serious problems. "Our point of view is Lariam is a very useful
medication in preventing a dangerous disease, and our experiences with it
have been good," Virginia Stephanakis, a spokeswoman for the Army surgeon
general's office, told United Press International earlier this year.

Lariam was developed by the U.S. Army in the 1970s, licensed to Swiss drug
giant Hoffmann-La Roche and approved for use in the United States in 1989.
The drug label warns of mental and neurological problems in a number of
people who take it, including aggression, suicidal thinking, psychosis and
depression. In some cases, those effects have been reported to last long
after a person stops taking it.

Last year, Roche changed the product label to warn of "rare cases" of
suicide, and the Food and Drug Administration has ordered the company to
provide detailed written warnings to each person to whom it is prescribed.

Last month, the Pentagon said that nearly 4,000 U.S. troops have been
medically evacuated from Operation Iraqi Freedom for non-combat reasons --
with more than one in five of those for psychiatric or neurological
problems, according to Pentagon data.

"Clearly there is more detail that needs to be given about the nature and
causes of these evacuations," said Steve Robinson, executive director of the
National Gulf War Resource Center. "Under psychiatric problems, how many of
these could be related to Lariam?"

In her letter, Feinstein raised the possibility that fear of the drug might
have led to an outbreak of malaria in more than 100 U.S. troops deployed to
Liberia in August.

"While news reports of preliminary interviews with sick soldiers suggest
that complacency was the primary factor behind their decision not to take
their Lariam pill, I am concerned that first hand experience with its side
effects and reports from fellow service members may have played some role in
their decision not to take Lariam," Feinstein wrote.

The letter cited the experience of Navy Cmdr. William Manofsky, who
volunteered to go to Kuwait as part of Operation Iraqi Freedom last December
and began taking Lariam. By the time he returned to California in March, the
letter said, "he experienced insomnia, aggression, agitation, rage, mood
swings, acute nausea, vomiting, severe anxiety, depression, cognitive
disorders and at times difficulty walking and communicating, conditions
which placed him in the emergency room five times.

"Unfortunately, doctors have informed Cmdr. Manofsky that some of these
conditions may be permanent."

Manofsky was the subject of a Sept. 8 article by United Press International,
in which he alleged that the Navy had altered his medical records to remove
mention of Lariam. Manofsky provided before-and-after pages from his medical
chart that appeared to show that references to the drug were missing. The
Navy surgeon general's office said at the time that it was working to
resolve the matter. Spokesman Brian Badura did not return a call Monday
seeking comment.

Susan Rose, co-director of Lariam Action USA, a group made up of people who
believe they have been harmed by the drug, welcomed Feinstein's letter and
said: "Contrary to the FDA's assertion that most people can tolerate the
drug, scientific studies prove that 1 in 3 will suffer a neuropsychiatric
adverse event and 1 in 5 will describe it as moderate to severe."

An Army spokesman told UPI the rate of serious side effects is 1 in 13,000.

Feinstein's letter marks the second time a member of Congress has written
Rumsfeld about the drug. In May 2002, Rep. John McHugh, R-N.Y., wrote asking
for a review of the military's use of Lariam out of concern that it might
cause mental problems among troops.

Assistant Secretary of Defense William Winkenwerder Jr. responded to McHugh
that reactions to the drug had been few and generally mild among service
members. But he added, "Sufficient evidence exists to raise the question
whether the neuropsychiatric adverse events of mefloquine (the generic name
for Lariam) are frequent enough and severe enough to warrant limiting its
use. However, sufficient evidence does not exist to answer the question,
especially in the case of military personnel."

UPI reporters began an investigation of Lariam in early 2002 and found that
mounting evidence suggests it has triggered side effects so severe that in a
small percentage of users it has led to suicide. UPI also reported that
soldiers involved in a string of murder-suicides at Fort Bragg in the summer
of 2002 after returning from Afghanistan had taken the drug, and that they
exhibited some behavior that matched known side effects.

The Army surgeon general's office dispatched a team to investigate. It
reported last November that the drug did not cause the entire cluster of
deaths because not everyone suspected in the homicides had taken it, but
didn't investigate whether the drug had caused any individual
murder-suicide. The report said the only common thread was marital problems,
perhaps aggravated by the stress of frequent deployments.

Roche, the manufacturer, says there is no reliable scientific evidence that
Lariam can cause violent behavior.

Copyright © 2001-2003 United Press International


Sempers,

Roger
:marine:

I would not be suprised if it was true. I have had bad health ever since the Gulf. We took loads Premethlaquine I think that was it, and it was nasty. We put a pill in some peanut butter and the rat that ate it died.

After that we all stoped taking the stuff.

Issue Date: December 08, 2003

Lawyer: Soldier’s panic caused by malaria pills

By Laura Bailey
Times staff writer

The anti-malaria drug mefloquine probably contributed to the panic attacks of an Army staff sergeant sent home from Iraq and charged with cowardice, according to the soldier’s lawyer.
“All the symptoms were exactly the same as what we read in the literature,” said Wayne Anderson, who represents Staff Sgt. Georg-Andreas Pogany.

“What really surprises me is that no one in the unit recognized the symptoms and tried to do anything about it,” he said.

The charges have been reduced to dereliction of duty. But the soldier and his lawyer say he is innocent of wrongdoing.

Pogany, 32, was on his second day of duty in Iraq and his third dose of mefloquine when he suffered panic attacks.

Mefloquine, taken by soldiers deployed to places like Afghanistan and the Middle East, has been said to cause a host of adverse physical and psychiatric reactions.

Also known by its brand name Lariam, the drug was called into question in a series of domestic killings involving soldiers at Fort Bragg, N.C., in the summer of 2002. Ultimately, Army investigators concluded it did not contribute to the homicides, but controversy remains over the military’s use of the drug.

Sen. Dianne Feinstein, D-Calif., recently wrote to Defense Secretary Donald Rumsfeld to ask that the Defense Department “consider revising the department’s policies” on prescriptions of Lariam, based on complaints from constitutents and “growing evidence” about its “dangerous side effects.”

literature provided by Lariam’s manufacturer, Hoffman-La Roche, says side effects include nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and sleep disorders. Those who take the drug also have reported adverse psychiatric and emotional effects, including panic attacks, anxiety, paranoia, depression, hallucinations and psychotic behavior, the literature states.

Pogany, an interrogator who was attached to a group of Special Forces soldiers from Fort Carson, Colo., said he experienced many of those symptoms the day after his arrival in Iraq.

He said that hours after seeing the mutilated body of an Iraqi, he suffered anxiety and headaches and couldn’t stop shaking and vomiting. When his condition failed to improve, he went to his superiors for help, but they told him to go away or face being sent home, he said.

After a couple of days, he said, his superiors took him to a base where he referred himself to a psychologist. The psychologist’s report diagnosed him as having symptoms consistent with combat stress.

Pogany said he never turned down a mission, yet two days later was sent back to Fort Carson, Colo., where he was charged with cowardice, a serious crime not prosecuted since the Vietnam War.

With the exception of a Nov. 6 press release announcing the reduction of charges, the Army has refused to comment on the case. A court date hasn’t been set for the latest charge, but the Army has 120 days from Nov. 6 to decide whether to prosecute.

Laura Bailey covers the Army.

http://www.marinecorpstimes.com/stor...ER-2425422.php

Sempers,

Roger
:marine: