May 20, 2004: Headlines: Lariam: Safety and Security of Volunteers: CNN: Military's use of malaria drug Lariam in question

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By Admin1 (admin) (pool-151-196-115-42.balt.east.verizon.net - 151.196.115.42) on Wednesday, May 26, 2004 - 6:41 pm: Edit Post

Military's use of malaria drug Lariam in question

Military's use of malaria drug Lariam in question

Military's use of malaria drug Lariam in question

Military's use of malaria drug in question
Pentagon studies Lariam's side effects after soldiers' suicides

From Maria Fleet and Jonathan Mann
CNN

Thursday, May 20, 2004 Posted: 1627 GMT (0027 HKT)

U.S. troops have been issued the anti-malaria drug Lariam, which can have severe side effects.

(CNN) -- U.S. Army Chief Warrant Officer Bill Howell began taking Lariam before going to Iraq in 2003. In March, three weeks after returning home, Howell fatally shot himself in his front yard.

Sgt. 1st Class Rigoberto Nieves also took the anti-malarial medication during his tour of duty in Afghanistan in 2002. Two days after coming home, he killed his wife and himself.

Although grieving families and some experts suspect a link between Lariam and the deaths, the Pentagon said it isn't sure. And until its conclusion of a study into the matter, the Defense Department said it intends to hand out the drug to U.S. military service personnel in some regions where malaria is a threat.

"The combination of the anecdotal reports and the perceptions have led me to conclude that we need to perform a study to ... see if there are the adverse outcomes that some believe there might be," said Dr. William Winkenwerder, assistant secretary of defense for health affairs.

There is no timeline for the probe, Winkenwerder said, but he has requested its completion as soon as possible.

"To take a proven effective drug out of the armamentarium to protect our soldiers is not something that we have the scientific basis to do at this time," he said.
Concern prompts FDA move

Since the Food and Drug Administration approved Lariam in 1989, more than 20 million people have received it, according to its maker, Roche Pharmaceuticals.

Roche warns that in rare cases Lariam can trigger nausea, sleep disorders, nightmares or thoughts of suicide. "Some patients taking Lariam think about killing themselves, and there have been rare reports of suicides," says company literature on the drug. "We do not know if Lariam was responsible for these suicides."

The Centers for Disease Control and Prevention warns of possible "visual disturbances" associated with Lariam, also known by its generic name, mefloquine. "Mefloquine has rarely been reported to cause serious side effects, such as seizures, depression and psychosis," the CDC's Web site says.

In July 2003, concern about the drug prompted the FDA to make a rare move. The agency called on Roche to craft a medication guide -- a warning written in laymen's terms -- that must be placed in the hands of each Lariam user.

The guide warns of "certain psychiatric adverse events -- anxiety, depression, restlessness or confusion" associated with the drug and advises "to contact a physician if such ailments present themselves." The special medication guide was not required by the FDA before the war in Iraq.

Based on UPI investigative reporter Mark Benjamin's interviews with 50 to 100 U.S soldiers, troops were routinely given Lariam without any information, written or verbal, about the drug's possible side effects.

Lariam is one of the most powerful drugs available to fight forms of a parasite resistant to one of the most commonly used anti-malarial drugs -- chloroquine.

Malaria kills an estimated 1 million people each year, according to the CDC.

Caused by a parasite passed from mosquitoes to humans, malaria occurs in mostly tropical and subtropical regions. Malaria carriers can suffer recurrent attacks of chills and fever and sometimes die.

Some U.S. troops were given Lariam while serving in Iraq and Kuwait until the military learned through its testing that drug-resistant forms are not a threat in those countries. It continues to be among the drugs the Pentagon uses to combat chloroquine-resistant malaria in Afghanistan.

The CDC does not list either Iraq or Kuwait as posing a risk of chloroquine-resistant malaria -- information that was available before the Iraq war began.
Cluster of killings

On March 14, Howell's wife, Laura, called Colorado's El Paso County 911 to report that her husband had hit her and had gone downstairs to get his gun.

A few minutes after the phone call, Howell, who had been taking Lariam while deployed with Special Forces in Iraq, walked out to his front yard and committed suicide. Laura Howell said she didn't know what drove her husband to take his life but she suspects Lariam.

During the summer of 2002, four soldiers at Fort Bragg, North Carolina, killed their wives -- and three of them killed themselves. Three of the four men had been taking Lariam before their suicides, according to Benjamin, who has done an extensive investigation into the drug and its use in military and civilian settings.

Benjamin interviewed family members and colleagues of the soldiers after the cluster of killings among the elite troops who used Lariam drew his attention.

Nieves fatally shot himself and his wife two days after returning from Afghanistan in June 2002, according to the Army.

Another of the Fort Bragg soldiers who took Lariam, Master Sgt. William Wright, confessed to strangling his wife a month after his return from Afghanistan. He later hanged himself while awaiting trial in jail, according to police.

Fellow soldiers who served with Sgt. 1st Class Brandon Floyd said he also was taking Lariam before he killed his wife and himself, although the Army said it could not confirm that he was taking the drug.

A fourth soldier, Sgt. Cedric Griffin, stabbed his estranged wife and set her body on fire, according to police. Griffin was the only soldier of the four who did not kill himself. Because he had not served in Afghanistan or Iraq, Griffin likely was not taking Lariam, according to Benjamin.

An Army investigation into the Fort Bragg killings also included a fifth soldier, who police say was killed by his wife. She's awaiting trial on murder charges.

The Army probe found that Lariam was not the cause of the Fort Bragg deaths -- a conclusion public health specialist Sue Rose disputes. Rose, who is working to raise consumer awareness about Lariam, said the Army erred in its investigation by including those who did not take the medication.

"The military is drawing the wrong conclusion from those deaths," Rose said. "The true cluster, the true group you want to look at are those men who took Lariam, and of the men who took Lariam, who all served in Afghanistan, all three of them killed their wives and subsequently committed suicide."

Rose said data from a recent study suggests that Lariam users experience significantly more moderate and severe neuropsychiatric side effects than users of three other comparable anti-malarial drugs.

Rose -- an assistant adjunct professor in the George Washington University School of Public Health and Health Services -- said she has been investigating Lariam since the early 1990s. She also has a law degree from the University of California, Hastings College of the Law. Rose has not performed an independent investigation into the killings at Fort Bragg.

Roche points out that the authors of the study cited by Rose also reported that "tolerability of the four ... currently recommended anti-malarial drugs ... is high, with no serious or adverse events and good quality of life reported."

CNN's Thom Patterson contributed to this report.




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Story Source: CNN

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

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