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FDA strengthens warnings on malaria drug

The Food and Drug Administration strengthened warnings about a pill used to both prevent and treat malaria on Monday, saying it can cause serious symptoms that include hallucinations amid a controversy that’s made it a drug of last resort for U.S. troops in the Middle East, Afghanistan and elsewhere.

The drug, mefloquine hydrochloride, is sold under brand names including Lariam, Mephaquin or Mefliam. “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,” the FDA says in a statement.

“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.”

Doctors and travelers have known for years that antimalarial pills can have psychiatric effects. The drugs can be used to treat malaria. Or taken before and during travel to an affected area to prevent infection.

People who take the drugs complain they can cause nightmares, dizziness and anxiety. But most controversially, psychiatrist Dr. Elspeth Ritchie of the Washington, D.C. health department, a retired Army colonel, suggests the drug may have been a factor in the case of Army Sgt. Robert Bales, who was charged with murder last year for shooting 17 Afghan civilians

Ritchie helped write a paper in the Journal of the American Academy of Psychiatry and the Law last month detailing what she terms psychosis from using mefloquine. “Exposure to the drug has been associated with acts of violence and suicide,” she writes.

“Mefloquine psychosis may be distinguished from schizophrenia and certain other forms of psychiatric illness in that it may feature prominent characteristics of dissociation,” she adds. In other words – patients may so something, yet see their actions as if they were watching from outside.

The FDA did not mention this case and says it’s still reviewing the safety of the drug. It notes that malaria is also a seriously and potentially deadly infection. It’s caused by a parasite transmitted in mosquito bites and can cause high fevers. The United Nations estimates malaria kills more than 600,000 people every year, mostly children in Africa.

But antimalarial drugs can cause serious side-effects. “Mefloquine may cause dizziness, balance problems, and ringing in the ears. These symptoms can occur at any time during use and can last for months to years after the drug is stopped or can be permanent,” the FDA cautions.

“If you already have or develop any mental problems, you should contact your health care professional right away,” it adds. These include anxiety, paranoia, hallucinations, depression, confusion and restlessness.

The Centers for Disease Control and Prevention lists drugs approved to treat and prevent malaria. They include Malarone, chloroquine and the antibiotic doxycycline. There's no vaccine to prevent malaria, although scientists are working on several.