FDA Raises New Safety Alert Over Pfizer Inc. (NYSE:PFE)’s Chantix; Refuses To Pull Down Black Box Warning

Pfizer Inc. (NYSE:PFE)‘s anti-smoking pill Chantix might not let smokers quit their habit very easily. Following the review of side effects attached with the pill, the Food and Drug Administration has raised a new safety alert on the drug, warning consumers about the probability of seizures and its intensifying effect on taking alcohol. Consumers can experience aggressive behavior, loss of memory for a brief period or amnesia, according to the FDA.

Where do analyst foresee upcoming resistance in PFE?

Black-Box warning remains

Also, the regulator has stirred up problems for Pfizer Inc. (NYSE:PFE) by refusing to pull off “black box” warning found on Chantix labels. The black box warning refers to the side effects of suicidal behavior and other psychological adverse impacts. The company had requested for the removal of the warning last year, but its latest data did little to convince the FDA. Black Box warning is counted among the most unfavorable warning that a pharma company would ever want on its label. The drug that once became the starry performer for the company fetching it $846 million in sales in 2008 lost the glow following the safety alert raised in 2009. Moreover, Pfizer Inc. (NYSE:PFE) had to shell out millions of dollars to settle the lawsuits pertaining to the drug.

Study initiated

Not, Pfizer Inc. (NYSE:PFE) is said to be conducting a larger study to identify psychiatric side effects attached to the drug. The issues surrounding Chantix surfaced after a number of medical journals and courtrooms started a debate in 2007 for the suicidal and agitated behavior. As per the current labeling on Chantix, the patients are recommended to stop taking the pill if they experience depression, agitation or other undesirable behavior traits.

Moreover, Doctors are advised to prescribe the drugs after comparing its potential benefits against the posed risks. The decision of the FDA followed its examination of 48 cases, where 37 people showed aggressive behavior and 11 people experienced greater intolerance to alcohol. It makes the path difficult for Pfizer Inc. (NYSE:PFE) to encourage people to quit smoking, when its pill produces far greater adverse impact than smoking itself.

About the Author

Laurie, a long-time member of the US Markets Daily general assignment reporter who has covered a variety of subjects from breaking news to investigative features, from stock markets to politics, and from neighborhood small business to global warming.

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