Thursday, September 19, 2013

FDA: Label changes for Antimalarial Drug Mefloquine Hydrochloride

News today  that Army Units to Stop Taking Anti-Malarial Drug.
The top doctor for Green Berets and other elite Army commandos has told troops to immediately stop taking mefloquine, an anti-malaria drug found to cause permanent brain damage in rare cases.
The ban among special operations forces is the latest development in a long-running controversy over mefloquine. The drug was developed by the Army in the 1970s and has been taken by millions of travelers and people in the military over the years. As alternatives were developed, it fell out of favor as the front-line defense against malaria, a mosquito-borne disease that international health officials say kills roughly 600,000 people a year.

This is further to a recent FDA report, below: 

The U.S. Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label.  FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears.  The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations (For a more complete list of potential side effects, see Additional Information for Patients).

Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent.  Patients, caregivers, and health care professionals should watch for these side effects. When using the drug to prevent malaria, if a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine should be used.  If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing health care professional.  The patient should not stop taking mefloquine before discussing symptoms with the health care professional.
Malaria is a serious disease caused by a parasite that commonly infects mosquitoes, which then bite humans.  It is a major cause of death worldwide but is less common in the United States.  The disease is a problem primarily in developing countries with warm climates.  Persons who travel to these countries may be at risk of malaria infection and should take drugs to prevent or reduce that risk. 

People with malaria often experience fever, chills, and flu-like symptoms.  Drugs must be taken to treat the disease if you have been infected, but may, themselves, have side effects.
FDA will continue to evaluate the safety of mefloquine and will communicate with the public again if additional information becomes available.