A non-profit drug research organization said today that, in the first quarter of 2008, the smoking cessation drug Chantix was the subject of more serious side effect reports than any other medication currently on the market. According to the Institute for Safe Medication Practices, during that time period, the Food & Drug Administration (FDA) received 1001 adverse event reports – including deaths – in regards to Chantix. Researchers at the Institute said Chantix needs to carry stronger warnings about its potential risks of accidental injury and death.
Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (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 the US, Chantix has been linked to suicides and attempted suicides. In November 2007, the 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.
Today’s Institute for Safe Medication Practices report said that for the first three months of 2008, Chantix had been linked to 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.
This is not the first time that the Institute has taken aim at Chantix. In May, researchers there reported that Chantix had been the subject of 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.
After the May report was released, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense all restricted the use of Chantix. Pilots and air-traffic controllers were told to stop using Chantix immediately.
This latest Institute report comes at a difficult time for Pfizer, the maker of Chantix, which has been trying to counter the drug’s bad publicity. It was only last month that Pfizer resumed running new ads on TV that mention Chantix by name. The company had ceased such spots last year, as concerns over Chantix side effects mounted. Since then, sales of the drug have fallen off.
Pfizer is undoubtedly desperate to salvage Chantix, as it was counting on the drug to become one of its major growth drivers. Pfizer had touted Chantix as a product that could help offset $12 billion in sales that the company’s Lipitor cholesterol medicine will begin losing to generic competition in 2010.
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