Washington, DC - The Department of Veterans Affairs (VA) is alerting its clinics of the "potential for serious complications associated with mefloquine," a generic anti-malarial drug also known by its trade name Lariam, Veterans Affairs Secretary Anthony J. Principi disclosed in a letter to U.S. Senator Dianne Feinstein ( D-Calif. ).

The VA will also provide resources to support a Department of Defense study of the effects of mefloquine under deployment and post-deployment conditions, Secretary Principi said in the July 6 letter, which was a response to a previous letter from Senator Feinstein. 

"The decision to alert VA clinics about the possible dangers from this drug that is being given to U.S. service members in Iraq and Afghanistan is a major step forward," Senator Feinstein said. " It is my hope that other agencies will take the same initiative."

Lariam has recently been found to have caused vestibular damage in eleven U.S. service members who recently served in the Middle East and may be linked to suicides and other violent behavior by its users. In recent months, Senator Feinstein has urged the Defense Department to establish a timeline for its study on Lariam use by soldiers, asked the Centers for Disease Control to review its recommendation of Lariam for use in chloroquine-resistant areas, and called on the Department of Health & Human Services and the Food & Drug Administration to collect data on the use of Lariam by Americans traveling abroad.

The Department of Veterans Affairs Information Letter on Lariam for clinicians is at the following website: http://www.va.gov/publ/direc/health/infolet/102004007.pdf. It provides the following guidance:

"Review of available literature . suggests that certain health effects may be associated with mefloquine, some of which may persist after the drug is stopped. Self-reported symptoms in "travelers surveys" include: insomnia, mood impairment, depression, 'strange thoughts,' altered spatial perception, sleeping disturbances, fatigue, dizziness and other neuropsychiatric effects, lasting in some instances more than 2 months. Clinical trials and epidemiological studies suggest that reported side effects are not common, are self-limiting, and include: depression, panic attacks, anxiety, insomnia, vertigo, nausea and headache, and strange or vivid dreams. However, such studies have only limited power to detect more rare and serious adverse events.

The most severe and persistent adverse effects appear in 'case reports.' In those instances, consistent with the nature of a case report, the relevant signs and symptoms began while mefloquine was being taken, and persisted in some reports for weeks, months or even years after the drug was stopped. NOTE: Mefloquine has a long half-life in humans of 15 to 30 days. Adverse effects that are reported to persist for significant periods after the drug is stopped, or that could be associated with long-term health effects, include the following which lists in decreasing frequency the cases; NOTE: The reported number of individual cases and the number of published reports for that health effect are shown in parenthesis; i.e., 16/12 means that there were sixteen reported cases and twelve published reports.

(1) Anxiety, paranoia, hallucinations, depression, suicidal ideation, cognitive and other neuropsychiatric symptoms (16/12),

(2) Acute and paranoid psychosis (10/9),

(3) Convulsions, grand mal seizures, coma and abnormal electroencephalography (EEG) (9/4),

(4) High frequency sensorineural hearing loss and tinnitus, with partial or no remission (3/1),

(5) Acute lung injury with diffuse alveolar damage (2/1),

(6) Elevated liver function tests or fatty liver (2/2),

(7) Multifocal myoclonus (1/1),

(8) Fatal toxic epidermal necrolysis (1/1),

(9) Trigeminal sensory neuropathy (1/1),

(10) Atrial flutter (1/1), and

(11) Mefloquine overdose induced encephalopathy (1/1).

Following is the text of the Secretary Principi's letter to Senator Feinstein:

July 6, 2004

The Honorable Dianne Feinstein
United States Senate
Washington, DC 20510

Dear Senator Feinstein:

This is in response to your letter to the Department of Veterans Affairs (VA) regarding the Department of Defense (DoD) use of the drug Lariam (mefloquine) in soldiers deployed in Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF). Please be assured that I share your concerns for the health of our Nation's service members.

I have committed the Department's resources to support DoD in its study of the effects of mefloquine under deployment and post-deployment conditions. VA's clinical experts will be made available to DoD as needed. The Honorable Gordon H. Mansfield, VA Deputy Secretary and co-chair of the VA-DoD Joint Executive Council, will work with his counterpart at DoD to see that any study that they undertake on this issue will proceed with all the assistance that VA can provide.

Because, as you correctly note, many of these returning service members will turn to VA for care, VA has taken steps to ensure that our clinicians are aware of these potential health effects and are prepared to treat affected veterans. The Veterans Health Administration is preparing an Information Letter outlining the potential for serious complications associated with mefloquine. This Information Letter also provides guidance to clinicians on diagnosis and treatment. Although there is currently no test to detect mefloquine in a person's system, clinicians are being urged to take careful medical histories, particularly medications used. Armed with this information, VA clinicians will be in the best possible position to identify and treat any conditions associated with use of mefloquine that may present in these new veterans.

Thank you for your continued interest in military service members and veterans.

Sincerely yours,

Anthony J. Principi