September 4, 2002 - New Jersey Online: Malaria-drug maker roche to warn of suicide risk

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By Admin1 (admin) on Wednesday, September 04, 2002 - 6:19 pm: Edit Post

Malaria-drug maker roche to warn of suicide risk

Read and comment on this story from New Jersey Online that says that the maker of a popular malaria-prevention drug, prescribed to thousands of U.S. travelers and military personnel, is planning to send notices to doctors and other health-care professionals noting that a small number of people have committed suicide after taking it.

Lariam is the most effective anti-malarial drug known and has been used by thousands of Peace Corps Volunteers over the past ten years. However, the drug's potential side effects are rarely reported and include agitation, depression and aggression.

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Malaria-drug maker roche to warn of suicide risk*

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Malaria-drug maker roche to warn of suicide risk


The Associated Press

9/4/02 10:04 AM

The Wall Street Journal

The maker of a popular malaria-prevention drug, prescribed to thousands of U.S. travelers and military personnel, is planning to send notices to doctors and other health-care professionals noting that a small number of people have committed suicide after taking it.

The drug Lariam, made by Roche Holding AG, is one of several medicines for physical ailments that have in recent years been reported to have worrisome psychiatric side effects. Some drugs for acne, arthritis, asthma, even some antibiotics have been reported to cause depression, anxiety and other types of emotional instability. While the vast number of people who take the drugs do fine with them, these rare side effects can be particularly scary.

Revisions to drug labels are fairly common, but Roche's new action may highlight potential side effects beyond the fine-print on a label. It comes as new questions are being raised about Lariam after army investigators said that they would examine whether the drug was one factor in a series of widely publicized murders and suicides by soldiers this summer in Fort Bragg, N.C. Investigators have yet to establish a direct link to the tragedies.

Roche and the federal Food and Drug Administration say that no link has been made between any suicides and Lariam. But in July, after ongoing discussions with the FDA, Roche changed the drug's label and official product information to acknowledge "rare cases of suicidal ideation and suicide have been reported." Now it plans to publicize the move by sending written notices to thousands of doctors around the U.S.

"If symptoms of acute anxiety, depression and confusion occur," the new label says, they could lead "to a more serious event." In such case, patients should quit the drug and take another malaria medicine.

Lariam, which has been prescribed to 25 million people world-wide since its introduction in 1985, is one of the most effective prevention treatments for malaria, one of the world's most deadly infectious diseases. The U.S. Centers for Disease Control and Prevention, recommends Lariam as the drug standard in 79 countries where malaria is resistant to other drugs. Developed by the U.S. army and later licensed to Roche, the drug was first tested and used primarily among the military. But it has grown popular with many U.S. tourists to increasingly trendy Third World destinations, as well as with Peace Corps volunteers and aid workers. Most have experienced only mild or no side effects.

"One has to look at the benefits and risks of this product," said Franz Humer, Roche's chief executive. "Its one of the few products that can prevent and treat malaria. We shouldn't look at this out of that context."

Still, some patients complain of hallucinations, nightmares, extreme anxiety, and even psychotic episodes. After taking three Lariam tablets on a trip to the Philippines, Bruce White, a 45-year-old civil engineer from St. Albert, Alberta, broke into cold sweats and felt like he was floating outside of his body. "I could see myself lying there with all of my intestines and everything exposed," he recalls.

By the time he checked into a hospital, he was having full-blown hallucinations, imagining people morphing into monsters. Over the next several days, he became violent, striking out at people. "I thought I was surrounded by shopping carts and I had to throw them out of the way," he says. "But they were people standing there."

For travelers, there are several alternatives to Lariam, but they all have drawbacks. Some are ineffective in countries where Lariam has proven effective. One alternative, doxycyline can lead to sun sensitivity and even burns. Another, Malarone, which the FDA approved in 2000, shows similar effectiveness to Lariam, but doctors caution that long-term studies on its safety haven't yet been done. Both doxycyline and Malarone have to be taken once a day, compared with Lariam's once-weekly regimen. Skipping a single day can expose a person to malaria.

"We might regret the day we get resistance to everything else and we don't have Lariam," says Ib Bygbjerg, professor of international health at the University of Copenhagen.

Doctors concerned about Lariam point to a study published last year in the journal Clinical Infectious Diseases that compared Lariam with Malarone, without revealing which participants got which. Of the 483 who received Lariam, 29 percent suffered mild to severe psychiatric side effects, compared with 14 percent in the Malarone group. GlaxoSmithKline PLC, which makes Malarone, sponsored the study.

It's less clear whether there's any link between Lariam and suicide. FDA records contain reports over the past four years of 11 suicides of people who had taken Lariam. The FDA says it has reviewed all of the reported suicide cases in detail, but was unable to establish any link to Lariam. In many cases, the descriptions were too vague to implicate the drug, it said. In others, the suicides happened long after the person had stopped taking Lariam or he or she suffered from a previous mental illness, the agency added. (The single reported case from the U.S. was Charles Perry of Cincinnati, who shot himself in January 1999 after taking Lariam the previous summer for an African safari. In May, Roche settled a lawsuit with his widow, but says the confidential agreement does not imply Lariam was responsible.)

Some doctors argue that patients need better information about Lariam's risks, particularly from the CDC, which is reviewing its guidelines on Lariam as part of a larger review of malaria prevention. The CDC Web site states that mefloquine, the generic name for Lariam, has very rarely been reported to cause serious side effects such as hallucinations and severe anxiety. But it doesn't provide a breakdown of what those risks are, nor does it mention any risk of suicidal thoughts.

British regulators, on the other hand, require more explicit consumer warnings, and five years ago, Britain's Malaria Advisory Committee recommended restricting Lariam to travelers going to malaria regions for more than two weeks.


Lariam Facts

For the prevention of: Malaria

Side effects include:

-- Depression

-- Anxiety

-- Hallucinations

-- Paranoid delusions and convulsions.

-- Rare cases of suicidal thoughts and suicide have been reported, but Lariam's maker, Roche, says no link to the drug has been determined.

Source: Physicians' Desk Reference, clinical studies


Scary Side Effects

Some other prescription drugs with reported psychiatric side effects:

DRUG: Accutane (Roaccutane in Europe)

TREATS: Severe acne

REPORTED SIDE EFFECTS: Mood changes, depression, suicidal thoughts. Patients must sign a consent form acknowledging they understand the side effects. Rare cases of suicide in Accutane users have been reported (about 140 out of 12 million total users), but no causal link has been established.

DRUG: Antidepressants, i.e. Paxil

TREATS: Depression

REPORTED SIDE EFFECTS: Occasional symptoms of vivid dreams, dizziness or slight serotonin "electric shock" sensation for a brief period after patients discontinue antidepressants.

DRUG: Ritalin

TREATS: Attention Deficit Hyperactivity Disorder

REPORTED SIDE EFFECTS: Nervous tics, lethargy and depression.

DRUG: Quinolones, i.e. Cipro, Levaquin

TREATS: Antibiotics for a variety of infections

REPORTED SIDE EFFECTS: Anxiety, restlessness, confusion, nightmares.

DRUG: Prednisone

TREATS: Steroid for inflammation, symptoms of arthritis, asthmas

REPORTED SIDE EFFECTS: Euphoria, insomnia, mood changes, personality changes, depression. It may worsen any existing emotional instability.

Source: Physicians' Desk Reference, clinical studies

Copyright 2002 Associated Press. All rights reserved.

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