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The new anti-smoking pill Chantix has been pulled from at least one military pharmacy in the Pacific following strong warnings linking the drug to serious psychiatric problems.

The drug, however, is still an option in many military smoking-cessation programs in the region, with health care providers saying Chantix has proved to be effective against nicotine addiction and can be used safely with proper screening and close monitoring. The health benefits of a smoke-free life, for some, outweigh the risks of using Chantix, typically prescribed over 12 weeks, doctors say.

But medical officials at Yokota Air Base in Japan were concerned enough with the drug’s potential safety risks that they voted recently to remove Chantix from the base pharmacy, according to Maj. Tam Dinh, 374th Medical Support Squadron pharmacy element chief.

The decision came after a May 21 report from the Institute for Safe Medication Practices, a nonprofit organization devoted to medication error prevention and safe medication use.

It found a suspected association between the Pfizer drug varenicline (marketed as Chantix in the United States) and sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia, psychosis and other adverse reactions, according to Dinh.

The report noted that in the fourth quarter of 2007, varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended that "varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members."

The DOD safety notice stated additional recommendations for "vehicle operators, operational personnel, and other DOD personnel are under consideration."

Those were just the latest warnings for Chantix.

The U.S. Food and Drug Administration earlier this year pushed Pfizer for new Chantix safety labels, citing a possible link to dozens of reports of suicides and hundreds of suicidal behaviors, according to the Associated Press. Pfizer added warnings to the drug’s label and said that although a link to serious psychiatric problems had not been proved, it could not be ruled out, The Associated Press reported.

At Yokota, Dinh said no patients on Chantix have reported any adverse reactions.

A patient with approval from his doctor can opt to continue the medication, and special order the drug, Dinh said in an e-mail to Stars and Stripes.

In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.

But at some of the region’s other base hospitals overseas, Chantix remains on the shelf, though air crewmembers can no longer take the drug per the DOD recommendation, officials said.

In South Korea, where Chantix is still available at Army military treatment facilities, Maj. Remington L. Nevin, U.S. Army Medical Department Activity Korea acting chief of preventive medicine, explained the peninsula’s Chantix policy: "Individual health care providers, after consulting with current DOD recommendations and FDA guidance, are free to exercise their clinical judgment in determining whether the potential risks of Chantix are balanced by its potential benefits to their patients."

He noted DOD currently does not prohibit Chantix use and no DOD policy mandates a formal screening process prior to prescribing Chantix.

The medical community at U.S. naval hospitals Yokosuka and Okinawa are taking a similar approach, leaving the decision of whether to take Chantix up to the patient and his physician.

"If I can help someone stop smoking, it is among the most beneficial health changes that I can help them make for their entire life," said Lt. Cmdr. Cormac O’Connor, a family practice physician at U.S. Naval Hospital Yokosuka.

At U.S. Naval Hospital Okinawa, Chantix is one of four medications available; the others are Zyban, nicotine gum and the nicotine patch, according to hospital spokesman Brian Davis.

Those undergoing smoking cessation must attend counseling, he said.

Patients on Chantix are told to stop taking the drug immediately if they experience any unusual behavior or psychological effects such as depression, irritable moods, thoughts of self-harm, or withdrawal from friends and family, Davis said.

Since January, 253 have been counseled for smoking cessation through the hospital’s health promotions department, Davis said. To date, he added, no one has reported any significant adverse psychological effects while using Chantix.

Nevin said Chantix has proved to be an effective aid in smoking cessation. He cited one study in which 44 percent of patients on Chantix successfully quit, compared to only 18 percent taking a sugar pill placebo.

"For many patients, the risks to their health posed by continued exposure to tobacco may far exceed the potential risks posed by Chantix," he wrote.

Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded.

In fiscal 2006, when Chantix was first licensed for use, DOD tracked 262 prescriptions in military treatment facilities, according to a May 23 DOD medication safety notice.

In fiscal 2007, the number of prescriptions jumped to 67,580.

In the United States, more than 5 million adults have been prescribed Chantix, according to Nevin.

But O’Connor cautioned "there’s no magic bullet." Chantix is "one of several medications. I think you have to choose which medication is best for your patient."

author picture
Jennifer reports on the U.S. military from Kaiserslautern, Germany, where she writes about the Air Force, Army and DODEA schools. She’s had previous assignments for Stars and Stripes in Japan, reporting from Yokota and Misawa air bases. Before Stripes, she worked for daily newspapers in Wyoming and Colorado. She’s a graduate of the College of William and Mary in Virginia.
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