New Warnings About Popular Stop Smoking Drug

The Pittsburgh Channel
22 October 2008

Millions of Americans have used the anti-smoking drug Chantix to kick the habit.

The drug, once linked to depression and suicidal behavior, is now under fire for a dramatic jump in serious injuries.

Kevin Kalia broke a two pack-a-day, 10-year smoking history with Chantix.

"That's the first time I've ever felt that I was pretty confident that I'd stay quit," Kalia said.

But there may be a dark side to Chantix. First reports of depression and suicidal behavior made drug maker Pfizerstrengthen the drug's warning label.

Now, using government data, the Institute for Safe Medication Practices or ISMP has issued a new report which blamed Chantix for 1,001 serious incidents involving users of the medication in the first quarter of this year.

ISMP says that's more adverse events than reported for any other prescription drug. The Food and Drug Administration is said to have reports of 15 events linked to traffic accidents and 52 other cases involve various blackouts.

Pfizer issued a statement saying: the ISMP's "report was based solely on a tally of post marketing adverse events.... Such reports are often unverifiable and lack sufficient medical information to draw any conclusions."

In May, Pfizer tried to cool the bad publicity about Chantix with full page ads in major newspapers refuting the findings. The action didn't seem to work. Chantix sales, which totaled $883 million last year, dropped and third quarter sales fell 49 percent.

The FDA has been reviewing the psychiatric side effects and issued a public health alert in May. It's not clear what if any action the FDA will take now. The FDA has a copy of the new report but so far the agency has not issued a comment.

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