Feinstein Calls for Review of Anti-malarial Drug
Service members continue to receive drug linked to permanent brain damage
Aug 18 2011
Washington—Senator Dianne Feinstein (D-Calif.) this month sent a letter to the Secretaries of Defense and Veterans Affairs urging them to strengthen safeguards regarding the use of the anti-malarial drug mefloquine to minimize its potentially severe side effects.
Despite a 2009 policy limiting its use to situations where other drugs are ineffective, mefloquine continues to be prescribed to U.S. troops deployed worldwide. The letter calls on the Defense Department to enforce its guidelines or consider more restrictive policies regarding its use. It also calls on VA to consider the drug’s adverse effects when assessing disability.
Following is the text of Senator Feinstein’s letter to Secretary Panetta and Secretary Shinseki:
August 2, 2011
The Honorable Leon Panetta
Secretary of Defense
1000 Defense Pentagon
Washington, DC 20301-1000
The Honorable Eric Shinseki
Secretary of Veterans Affairs
810 Vermont Ave. NW
Washington, C 20503
Dear Secretary Panetta and Secretary Shinseki:
I write to you regarding my ongoing concern with the use of the anti-malarial drug mefloquine (brand name Lariam®) and its long term adverse effects. Mefloquine is known to cause serious side effects including gastrointestinal upset, dizziness, sleeplessness, vivid dreams, anxiety, paranoia, and hallucinations. In most patients, the side effects subside after discontinuing the medication. However, in some instances mefloquine has been shown to have potentially serious neurological side effects including irreversible brain stem and vestibular damage resulting in balance problems, vertigo, and psychotic behaviors.
In a September 2009 policy memorandum, the Department of Defense removed mefloquine as the drug of choice for malaria prophylaxis. Per the memorandum, mefloquine was only to be prescribed in limited cases where the three preferred drugs were specifically contraindicated or unlikely to be effective. Additionally, the Federal Drug Administration requires that a pocket card describing the side effects and when to seek medical treatment be dispensed with each prescription. My office has been contacted recently by servicemembers who were prescribed mefloquine when one of the other medications would have been appropriate and were not given the FDA information card. These servicemembers are now suffering from the preventable neurological side effects described above.
Mefloquine is contraindicated in patients with traumatic brain injuries, post traumatic stress disorder and other psychiatric illnesses, from which we know many of our servicemembers and veterans suffer. If followed, the 2009 Department of Defense Policy on the Use of Mefloquine in Malaria Prophylaxis provides safeguards against the inappropriate use of mefloquine. I am concerned by reports over the past two years of medical providers either not aware of or not following this policy. What immediate steps can the Department of Defense take to reinforce these important guidelines?
I recognize that no drug is without danger. In light of the possible long term complications, I ask that you investigate restricting the prescribing and/or dispensing authorities for this medication. However, with more effective and safer malaria prevention and treatment medications available, I would question the need to maintain mefloquine on any Department of Defense or service specific formulary. As you review the 2009 policy, I ask that you evaluate the risks versus the benefits of mefloquine and assess the value of maintaining this drug on the main formulary.
In correspondence in 2004, I asked the Departments of Defense and Veterans Affairs to study the effects of mefloquine toxicity as a basis for diagnosis and assessing disability. It is my understanding that there still is not a definitive protocol for diagnosis or treatment of mefloquine toxicity in either organization. Therefore, I once again urge you to address this issue by adding mefloquine toxicity as a focus area for research under the Defense Medical Research and Development Program and the War Related Illness and Injury Study Center.
Mefloquine has shown the potential to do long term harm. We must do what is necessary to prevent future incidents and support those who have been affected. I strongly encourage you to leverage the assets of the Departments of Defense and Veterans Affairs to ensure we are providing our servicemembers and veterans with the treatment and support they need and deserve. I know you share my concern for the health and well being of the men and women of the Armed Forces, past and present. I look forward to working with you on this important issue.
United States Senator