chantix Louis J. Sheehan, Esquire 88220

The Institute for Safe Medication Practices, a Horsham, Pa., organization that seeks to improve drug safety, released findings Wednesday on its review of adverse-event reports filed with the FDA. The reports included 988 serious incidents linked to Chantix in the U.S. during last year's fourth quarter -- the most for any medication in that period. Late Wednesday, prompted by the nonprofit's report, the Federal Aviation Administration banned the use of Chantix by pilots and air-traffic controllers.

Chantix has already been connected to psychiatric problems, including suicide and depression, but this report suggests links to problems such as heart trouble, seizures and diabetes.

Thomas Moore, the study's lead author and the institute's senior scientist for drug safety, called on Pfizer and the FDA to "immediately" strengthen Chantix's label warnings and rigorously examine emerging safety issues. "Based on the data available now, the existing warnings are completely inadequate," he said. "You'd expect a stop-smoking drug to have a relatively low number of reports," because it isn't used in high-risk patients. http://www.myspace.com/louis_j_sheehan_esquire


Pfizer and the FDA routinely examine the same reports the institute reviewed. An FDA spokeswoman acknowledged that the study raises potential safety concerns and deserves more investigation, but she said that because of staffing shortages, the FDA is focusing for now on Chantix's possible psychiatric effects. Pfizer said the report's findings are consistent with the drug's label, which lists many of the events cited in the institute's report as "infrequent" or "rare." It also said that the reports aren't unusual, given that roughly 5.5 million Americans have taken Chantix.

Chantix, a pill that acts on brain receptors affecting the desire to smoke, went on the market in the U.S. in 2006 and became an $883 million success within a year. Concern about its potential link to suicidal thinking and depression prompted the company to include precautions in the prescribing information in November, January and last Friday.

In November, the FDA said it was evaluating reports of drowsiness and said Chantix users should use caution when operating machinery or driving. Those concerns have slowed sales growth, and yesterday's report prompted Sanford Bernstein analyst Timothy Anderson to cut 2012 forecasts for Chantix sales to $700 million from $1.6 billion.

Mr. Moore's study links the drug to a greater spectrum of maladies. The report identified 173 injuries, including falls and traffic accidents, involving people taking Chantix that were possibly the result of such factors as muscle spasms, dizziness and confusion. The FDA data also contain 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.

After just months on the market, Chantix broke into the small group of medicines with more than 100 reports of serious injury. In the 2007 fourth quarter, with nearly 1,000 reports, it topped the group's list of 769 drugs examined in the U.S. for serious side effects. By contrast, the median number of serious-injury reports for other drugs is five. Most medications that came close to Chantix carry the FDA's most-serious "black box" warning, the study says.

The institute's findings have limitations. Using adverse-event reports doesn't establish a causal relationship between a drug and a side effect. Such reports are turned in by doctors, patients and sometimes plaintiffs' lawyers positing a connection but not proving one. Mr. Moore, who has consulted for plaintiffs' attorneys on drug issues, said the study isn't being published in a medical journal because he wanted to publicize the findings more promptly. A spokeswoman for the ISMP says that the group doesn't receive funding from plaintiffs' attorneys or other parties with a commercial interest in this report, and is primarily financed through subscriptions to its newsletter and grants.

The FAA initially said it was taking a second look at Chantix -- which it approved for use by pilots in July 2007 -- before the FDA added warnings about behavioral problems and drowsiness. But the agency opted for a ban in light of the latest evidence. "Based on this emerging information, it is no longer acceptable" for controllers and pilots to be taking the drug, said FAA spokesman Les Dorr.

The FAA sent letters Wednesday afternoon telling pilots who have been taking Chantix that they shouldn't fly for 72 hours. About 150 pilots and 30 air-traffic controllers may have been affected.

Pfizer said the Chantix label already warns against driving or using heavy machinery until users know how the medicine affects them. The company said the label reflects the medicine's risk-benefit balance, listing, among other things, diabetes, vision disturbance and cardiac arrhythmia as infrequent occurrences and balance disorder, impaired motor skills and atrial fibrillation as rare.

FDA spokeswoman Susan Cruzan said the FDA is continuing to review neuropsychiatric events but hasn't initiated an investigation into other side effects reported by the institute.