What's Next For Chantix?

The smoking cessation drug, Chantix has been in the news lately and for all the wrong reasons, and now the Food and Drug Administration is taking a closer look  at the drug and its side effects.

Pfizer makes Chantix which has been linked to hundreds of reported cases of problems among them, heart troubles, vision loss, accidents, diabetes, mental confusion, loss of consciousness and psychiatric side effects.

The drug mimics the effects of nicotine and is said to help people stop smoking fairly effectively.

The FDA’s Center for Drug Evaluation and Research says the agency is looking at the hundreds of adverse reactions to Chantix. “We are looking at them, but it takes a while,” says Janet Woodcock of the FDA told Reuters. 

The FDA’s position has been that Chantix should remain on the market to help smokers quit. The agency issued a public safety advisory this year for patients and health care providers to be on alert for changes in the mood and behavior of those taking Chantix.

A study from the Institute for Safe Medication Practices finds that in the last quarter of 2007, there were 988 serious injuries reported to the FDA, more than for any other drug reports during the same period.  

It is reported that 35 drugs had more than 100 serious adverse event reports (SAE). Chantix was first at 988 reports, while interferon beta had 640. Etanercept (555), infliximab (554), and fentanyl (404), oxycodone ( 372) followed.     

Woodcock tells Reuters, "We are not able to put the amount of resources against this we would need to do it in a very prompt matter.”

Following that report, the Federal Motor Carrier Safety Administration warned truck drivers not to use Chantix and medical examiners to disqualify anyone currently on the medication from obtaining a commercial motor vehicle license.

The Federal Aviation Administration banned the use of Chantix for pilots and air traffic controllers last week.  And
the military reportedly bans the use of Chantix for missile and flight crews.

One of the side effects is an inability to operate machinery and the tendency to have accidents.  Among the reports to the FDA were over 170 accidental injuries and about two dozen traffic accidents which the Institute linked to Chantix use. 

Daniel Williams had no health problems when he began taking Chantix to quit smoking. His girlfriend reports that a couple of nights after starting the drug, he was driving his pickup truck on a Louisiana country road.

She says she saw his eyes roll back into his head and he swerved off the road landing in a bayou.  Both got out alive and his doctor connected the incident to his use of Chantix.  

Earlier this year, the label on Chantix was updated to warn of suicidal thinking and depression.  Vivid dreams, also known as “Chantix dreams,” are also a frequently reported side effect.

Kathy MacInnis says Chantix put her in a calm place and she reports no health problems.  “You kind of feel high,” she tells the Los Angeles Times.

Pfizer flew her to New York to tape some commercials.

Prescriptions for Chantix are reported to be declining and shares of Pfizer closed at $19.33, down $.20 from the previous day.

Pfizer says that 5.5 million Americans have taken Chantix so the proportion of problems, reported to be more than 3,000, is relatively small in comparison.  

And withdrawal from nicotine might be a complicating factor.   #