After being approved by the FDA in 2006, Chantix was given a black-box warning by the FDA for the serious adverse effects caused by the drug. America Tonight

Tina Hurst was living what she considered a perfect life in her quiet neighborhood in suburban Chicago. She was happily married, the mother of two teenage girls and an executive at an insurance company. Hurst also had a secret. She was a closet smoker, an on-again, off-again, pack-a-day habit she’d hidden from her family. “I would quit for a couple of months and then I would start back again, so it was one of those periods where my family thought I was still not smoking, and I had started again,” Hurst said. Hurst called her doctor, who suggested a prescription drug called Chantix, which is designed to help smokers quit by curbing the desire to light up. Hurst thought she’d found an easy fix. Wiithin a week, she quit smoking. “I thought it was a miracle drug, you know?” she said. As Hurst continued taking the drug as prescribed, her well-ordered life started coming unhinged and she began acting erratically. After her husband convinced her to throw the pills away, Hurst said she went over the edge. “It was just like, boom! Something went wrong,” she said. Hurst, who said she’d never been depressed or suffered from any other mental illness, started experiencing hallucinations and suicidal thoughts. Hurst threatened to jump out of a moving car, forcing her parents called 911. Hurst wound up spending five days in a locked-down psychiatric ward at a local hospital, a nightmarish experience she blames on Chantix. Chantix, approved by the U.S. Food and Drug Administration in 2006, has a long history of users – and their next of kin -- reporting troubling, sometimes deadly, side effects they blame on the drug. In the last five years, 544 suicides and 1,869 attempted suicides have been reported to the FDA as “adverse events” in connection with Chantix, according to documents obtained by America Tonight under the Freedom of Information Act. Adverse events are side effects reported to the FDA by patients, doctors or health professionals, or the drug makers themselves. The reports don’t prove cause and effect but serve as an early warning system of sorts for the FDA, which monitors federal drug safety.

Side effects ‘off the charts'

In 2008, Thomas J. Moore, senior researcher with the Institute for Safe Medication Practices, was testing new software to analyze adverse events when he made a startling discovery. “Here, basically going off the charts, was this new smoking-cessation drug called Chantix,” Moore said. Moore found that Chantix was responsible for more adverse events – including the type of serious psychiatric episodes such as Hurst’s – than any other drug on the market. They fell into four categories: suicidal behaviors, depression, psychosis and aggression. “There were side effects that made it look like it was unsafe for pilots and people in critical occupations because there were seizures, blackouts, temporary blindness, blurry vision,” he said. Based on Moore’s research, the Institute for Safe Medication Practices issued a report saying the group had “immediate safety concerns” about Chantix “among persons operating aircraft, trains, buses and other vehicles.” The Federal Aviation Administration and Defense Department took heed and banned Chantix use among pilots and air traffic controllers. The military also banned Chantix for missile crews. The Federal Motor Carrier Safety Administration, the federal agency that governs truckers, said Chantix may “adversely affect the driver’s ability to safely operate a motor vehicle.” And the Department of Transportation sent a memo to the Federal Railroad Administration warning of “the potential threat to public safety caused by the anti-smoking drug Chantix.” In July 2009, the FDA slapped a so-called black-box warning on Chantix – the most serious warning possible – saying the drug “has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.”

Prospects for violence?

Moore continued digging into adverse event reports, particularly those involving violence. He co-authored a 2010 study in the Annals of Pharmacotherapy analyzing 26 acts of violence reported to the FDA as adverse events associated with Chantix. The study called them “inexplicable and unprovoked": “A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car…A 42-year-old man punched a stranger at a bowling alley…A 24-year-old started beating her boyfriend in bed because ‘he looked so peaceful’ and she later attempted suicide.” “These cases had three striking characteristics,” Moore said in an interview at his Alexandria, Va., office. “First, the violence was absolutely unpredictable and senseless. Second, the victim was anybody who happened to be nearby. It could have been a fiancé. It could have been mother. It could have been a police officer. And third, these people had no history of violence and were unlikely prospects for a violent act.” Clinical trials of Chantix have failed to turn up suicidal behavior or the type of aggression and violence reported to the FDA as adverse events. “Pfizer believes in and supports Chantix as an important treatment option for adult smokers who want to quit and takes the safety of all of its medicines seriously,” Pfizer said in a statement to America Tonight, adding that the drug has been prescribed to more than 20 million people worldwide.

The future of Chantix

Smoking remains the largest cause of preventable death and disease in the United States, and the FDA is standing behind Chantix, which has a 12-month quit rate of 22 percent, slightly better than counseling or nicotine-replacement therapy such as the patch or gum. The FDA declined to an interview for this story, but gave a statement to America Tonight: “Although Chantix, like any medication, is associated with a number of adverse effects, appropriate patient monitoring and selection can reduce the likelihood of these adverse events occurring.” Dr. Michael Siegel, a professor at Boston University’s School of Public Health who has studied smoking for 25 years, said it’s unrealistic to ask doctors to monitor for attempted suicide. “The use of a black box warning is to help physicians identify early symptoms that so that you can prevent the adverse event from occurring,” Siegel explained. “In the case of Chantix, the black box warning is basically telling physicians, ‘Be careful because your patients might die taking this.’ What use is it to monitor patients for suicide? Once they commit suicide, it’s over.”