British Regulators Report 10 Chantix SuicidesNov 10, 2008 | Parker Waichman LLP
Chantix has been linked to 10 suicides in the United Kingdom, according to that country's health regulators. This is the first time officials at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed the link between Chantix and suicide in that country. Earlier this year, the U.S. Food & Drug Administration (FDA) said it had linked 37 suicides to Chantix.
Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
But the drug has been the subject of disturbing side effect reports. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many reports of suicidal behavior it had received in relation to the drug 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.
Just last month, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
Earlier this year all pilots and air traffic controllers in the US were banned from taking Chantix because of fears about potential side effects.
In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.
The MHRA also says the number of users reporting adverse side effects while using Chantix has doubled in the past seven months – up from 1,811 in February to 3,541 in September. The British health watchdog is now warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.
Last December, the European Medicines Agency ruled that the inserts in boxes of Chantix be updated to include warnings about suicide and depression.