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More data links anti-smoking drug, suicide

A new study from the Food and Drug Administration appears to back up claims that a smoking-cessation drug used by service members and veterans may put them at risk for suicidal thoughts.

In fiscal 2007, some 67,580 service members had prescriptions for the medication, according to the Defense Department.

The study, published recently in the Journal of the American Medical Association, linked varenicline with 19 deaths and 112 serious incidents involving injury, hospitalization or emergency intervention after people took the drug to help them stop smoking.

The FDA called a link between suicidal ideation and the drug “likely” — even for those with no prior history of mental health issues — and said it’s important for physicians to monitor patients who take the drug.

“Continued reports of crashes and other serious adverse events among patients taking this drug also have raised concerns about other possible risks,” the JAMA article stated.

The FDA also found similar problems for Bupropion, which was linked to 46 reports of suicidal ideation between May 2006 and November 2007 and 29 reports of suicidal behavior, with about one-third resulting in death.

The FDA also found 988 reports of serious injury in the last three months of 2007, “more reports to the FDA’s adverse report system than for any other drug,” JAMA said. Problems have included car accidents, skin reactions, cardiac problems and diabetes-related symptoms.

Varenicline has changed its label to include a warning about potential mood changes and to advise patients who experience such effects to quit taking the medication immediately.

In June, then-Assistant Secretary of Defense for Health Affairs Dr. S. Ward Casscells issued a safety notice about varenicline that encouraged service members to seek help immediately if they have an adverse reaction to the drug. He said the Defense Department does not include the drug in its formulary, but many military health care beneficiaries have prescriptions for it.

A Defense Department safety notice issued last May advises pilots and other operators of heavy machinery not to take the medication.

“Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings,” the safety notice states. “The extent to which varenicline has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported.”

The drug first made headlines when the Washington Times newspaper reported that the Veterans Affairs Department gave it to veterans with post-traumatic stress disorder to help them stop smoking, leading two lawmakers to ask for an investigation.

A recent study by a Navy physician who embedded with Marines and sailors in Hadithah, Iraq, found that almost two-thirds of the more than 400 troops he surveyed in the war zone use some kind of tobacco, and that about three-quarters wanted to quit.