In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning – the agency’s highest safety alert.
The decision to remove Chantix from the pharmacy at the Yokata Air Base was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.
The report noted that in the fourth quarter of 2007, Chantix 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 Chantix “should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”
According to the “Stars and Stripes” website, no Chantix patients at Yakota have reported any adverse reactions. A patient with approval from his doctor can opt to continue the medication, and special order the drug. 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.
Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded. In 2006, only 262 Chantix prescription were written at U.S. military medical facilities. By 2007, that number had jumped to 67,580,
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