On Monday, the Food and Drug Administration (FDA) strengthened warnings about a drug to prevent and treat malaria because it can cause serious symptoms, including hallucinations, which has resulted in making it a drug of last resort for U.S. troops in the Middle East, Afghanistan and elsewhere.
The drug, mefloquine hydrochloride, has many side effects and is sold under various brand names, such as 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,” according to the FDA in a statement.
“A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label,” the agency said. “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.”
Although it’s been known for years that the pills can have psychiatric side effects, the drugs are used to treat malaria, or to otherwise prevent infection after traveling to a malaria ridden area.
Those who have taken the drugs have complained that they can cause nightmares, dizziness and anxiety. However, retired Army colonel and psychiatrist Dr. Elspeth Ritchie of the Washington, D.C. health department, believes the drug may have played a role when Army Sgt. Robert Bales shot and killed 17 Afghan civilians last year, which has since resulted in a murder charge against him.
Ritchie helped write a paper in the American Academy of Psychiatry and the Law last month that details what Ritchie refers to as 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,” Ritchie adds. Put simply, she’s saying that some patients may do something that they perceive as if they were on the outside looking in.
Meanwhile, the FDA says it’s still reviewing the safety of the antimalarial drug, and points out that malaria is also a seriously and potentially deadly infection.
Malaria is caused by a parasite transmitted in mosquito bites, which can result in high fevers. Malaria kills over an estimated 600,000 people per year, mostly children in Africa, according to the United Nations.
However, the serious side effects from antimalarial drugs are problematic.
“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,” the agency adds. Such problems include anxiety, paranoia, hallucinations, depression, confusion and restlessness.
While there aren’t any vaccines to prevent malaria, researchers continue to work on several.