Chantix Damage Control Begins

The news has not been good about the smoking cessation drug, Chantix, and now maker Pfizer is planning some damage control. 

With the Federal Aviation Administration and the trucking industry telling airplane pilots, air traffic controllers, and truck drivers to stay off of Chantix because of its link to more than 100 accidents, the drugmaker is pushing back.

Pfizer Inc. has an ad and public-relations campaign planned to try and regain some of the luster lost from its once touted blockbuster drug.

The FDA reports that higher doses of Chantix help smokers quit more effectively but also has greater incidents of potentially harmful side effects such as psychotic episodes, depression, aggression, dizziness and fainting, as well as vivid dreams.

The ads will run in five major newspapers.  And plan to see the media corralled in for round-table discussions about the risk of Chantix versus its benefit.

Pfizer had hoped to regain some of the $13 billion it lost from the generic competition to its cholesterol drug, Lipitor, but the stock price on Chantix is near a 52-week low.

Senator Charles Grassley of Iowa is encouraging the FDA to seriously study the research gathered by the Institute for Safe Medication Practices (ISMP), a nonprofit that studies medications.

It that found Chantix posed a risk of 988 serious side effects counted in the last few months of 2007.

Under fire by Grassley and two powerful committees, the FDA has promised to get back to his staff for a briefing next week.

Susan Cruzan of the FDA says the agency takes the ISMP report on Chantix “very seriously” even though it does not know whether Chantix has a direct link to the side effects or whether nicotine withdrawl may play a role.

FDA scientists are sorting through the adverse report cases, though admittedly, without the adequate number of personnel that would speed up a review.#