First in Class; September 2008; Scientific American Magazine; by Christine Soares; 3 Page(s)
As the pharmaceutical giant Pfizer was reminded in May, arriving first has its rewards, but they come with the risks of venturing into uncharted territory. This past spring the Federal Aviation Administration banned pilots and air traffic controllers from taking the company¿s popular smoking-cessation aid, varenicline, which is sold in the U.S. as Chantix. Amid 6.5 million prescriptions written worldwide since 2006, the drug had spawned highly publicized reports of acute psychiatric episodes that included seizures, psychosis and suicidal depression. In May the nonprofit Institute for Safe Medication Practices documented 988 such ¿adverse events,¿ prompting the aviation ban.
The Food and Drug Administration has now added strong warning language to varenicline¿s medication guide, and Pfizer is reviewing evidence that might help explain the rare but severe incidents. Although the bad publicity may dampen sales of the drug, observers say that some adverse events are not unexpected when a new drug hits the market, especially one that is the first of its kind. Varenicline is not just a novel smoking-cessation tool; it is the first of an entire class of medications specifically designed to target a powerful family of receptors on the surface of brain cells. Known as neuronal nicotinic acetylcholine receptors, they can mediate pain, mood, memory, attention and other cognitive functions.