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Top DoD doctor: Black-box malaria drug should be prescribed only as last resort

Aug. 8, 2013 - 07:21PM   |  
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The Pentagon’s top doctor drafted a memo this week reminding military physicians that the anti-malaria drug mefloquine should be prescribed only as a last resort, reserved for those allergic to other malaria preventives or traveling to areas where a strain is resistant to first-line options.

The memo, issued by Assistant Secretary of Defense for Health Affairs Dr. Jonathan Woodson, followed an FDA announcement July 29 that a “black box” warning had been added to the medicine, once marketed as Lariam in the U.S., because of potential neurological and psychiatric side effects.

The memo “reiterates our policy relative to very limited use of mefloquine and informing the services and all concerned about the black box warning,” Woodson told an audience of medical personnel at the Reserve Officers Association National Security Symposium in Washington, D.C., on Aug 8.

According to Defense Department data, 5,370 mefloquine prescriptions were issued to 4,770 Tricare beneficiaries in 2012, including 2,030 active-duty troops.

That is down significantly from previous years: Between 2010 to 2011, the military health system wrote 14,420 prescriptions for mefloquine, down from 55,766 from 2007 to 2009.

The new black box warning — the FDA’s most serious warning — followed an extensive review in which agency officials determined that neurological side effects such as dizziness, loss of balance or tinnitus can “persist or become permanent” as a result of taking mefloquine.

The medication also can cause psychiatric side effects ranging from anxiety and depression to hallucinations and paranoia, according to the FDA.

Mefloquine has been controversial since its commercial introduction in 1989. The drug is known to cause hallucinations, psychosis and delirium in a small percentage of users.

It was implicated in a string of violent deaths and suicides among several soldiers and spouses at Fort Bragg, N.C., in 2002 and in 2006, Congress ordered the Defense Department to study whether it played a role in a number of in-theater suicides in Iraq.

In its final report, completed in October 2009, DoD cited four studies that did not show an “apparent link” between mefloquine use and suicide.

The drug’s side effects also have been discussed in connection to the behavior of Army Staff Sgt. Robert Bales, who pleaded guilty in June to the murder of 16 Afghan civilians in March 2012.

At some point during his career, Bales was prescribed mefloquine, according to his attorney, John Henry Browne.

In a report sent by Lariam manufacturer Roche to the FDA, the maker said they were told that a soldier was “administered mefloquine in direct contradiction to U.S. military rules that mefloquine should not be given to soldiers who had suffered traumatic brain injury.”

Bales reportedly suffered a TBI as the result of a rollover accident in Iraq in 2010.

Military policy states that mefloquine should be a last-choice malaria preventive in areas where strains are resistant to another drug, chloroquine, behind doxycline and atovaquone-proguanil.

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