Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping"

Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping" | Pharmaguy's Insights Into Drug Industry News |

A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels.


For example, the researchers point to two recent cases where drugmakers petitioned FDA to lift a black box warning from one of their products.


In one case, Pfizer unsuccessfully petitioned FDA to lift a boxed warning for severe psychiatric events, including suicidality, from its smoking cessation drug Chantix. Five years after FDA recommended a boxed warning on the label for Chantix, Pfizer asked the agency to remove the warning based on data from five short-term observational studies.


However, after convening a joint meeting of its Psychopharmacology Drugs and Risk Management Advisory Committees, FDA opted to maintain the black box warning for the drug.


In another case, GlaxoSmithKline (GSK) managed to persuade FDA to remove the black box warning for its blockbuster diabetes drug, Avandia, using an independent analysis of data from a large randomized open-label controlled trial.


In both cases, the researchers say FDA's decision to impose a black box warning was based on less evidence than was necessary to support the removal of a warning. This is necessary, they argue, as FDA must act quickly to protect patients when safety issues emerge.


However, when it comes to removing a warning, the researchers argue that FDA should require more substantial evidence than it used to impose the warning in the first place.


"To avoid frequent flip-flopping, we believe it is ethically justified for the FDA to require a greater burden of proof, or a greater level of certainty provided by the evidence at hand, to justify removal of a boxed warning than it did to impose one," they write.

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Pfizer Wants Black Box Removed From Chantix Label

Pfizer Wants Black Box Removed From Chantix Label | Pharmaguy's Insights Into Drug Industry News |
In a boost to Pfizer, the FDA has updated labeling on its Chantix smoking-cessation pill to indicate the drug may not carry the risks of suicidal behavior, a controversial issue that prompted the agency to include a serious warning in the labeling in 2009.

The labeling change, by the way, was made on September 19, but Pfizer had not publicly discussed the changes until today, when a watchdog group called the Institute for Safe Medicine Practices planned to release an analysis placing Chantix in an unflattering light and calling for the Black Box warning to be strengthened. The timing of the disclosure of the labeling change suggests that Pfizer sought to mitigate any negative publicity that may have ensued.

The labeling change also comes just three weeks before the FDA holds an October 16 meeting to discuss “safety data from observational studies and a meta-analysis,” according to a September 9 notice in the Federal Register. These are the same data that is now referenced in the updated Chantix labeling. So why have a meeting?

Pfizer would like the serious warning, which is known as a Black Box in regulatory parlance, removed, the Associated Press writes.

Meanwhile, ISMP reviewed side effect reports filed with FDA and found that Chantix accounted for more cases of suicide, self-injury or homicidal thoughts than any other therapeutic drug between 2007 and the third quarter of 2013. Moreover, Chantix ranked first in both suicidal and self-injurious thoughts as well as homicidal thoughts, and these reports outnumbered those for any other drug by more than three times.

Pharma Guy's insight:

Chantix may be "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch," as reported by authors of this study: "New study says Chantix raises suicide risks"

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FDA says Pfizer's Chantix must continue to be Pilloried by 'black box' label

FDA says Pfizer's Chantix must continue to be Pilloried by 'black box' label | Pharmaguy's Insights Into Drug Industry News |
Pfizer's controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts.

On Thursday, an advisory panel for the regulatory agency voted to hold fast on maintaining the FDA's most severe warning label on the product, which has been reported to trigger suicidal depression, intense anger and other psychiatric troubles. Those claims began to surface soon after Pfizer launched the stop-smoking drug in 2006.

The label and news reports quickly eroded Chantix sales, which have dipped by $648 million this year, slightly off from 2013--and significantly down from $846 million recorded in 2008. Plus there were the lawsuits. Last year, Pfizer paid out more than $275 million to settle thousands of them alleging that Chantix triggered suicides, suicidal thoughts and other psychiatric problems.

Pharma Guy's insight:

In the Larry Niven science fiction story, Death by Ecstasy, a belter, Owen Jennison, is found dead on Earth in a locked Los Angeles apartment. His death is an apparent suicide. Hamilton, a friend and former crewmate of Jennison, is called to the scene to investigate. He finds Owen with a droud (a wirehead's transformer) plugged into the back of his head. The latter apparently starved himself to death while continuously stimulating the pleasure center of his own brain.

In the real world of today, there are many legal and illegal drugs and other chemical compounds that people use to stimulate their pleasure centers. One such agent is nicotine. Another is Pfizer's Chantix, a smoking cessation drug that competes with nicotine to stimulate the brain's pleasure center. In other words, Chantix takes the place of nicotine and like nicotine stimulates dopamine production, which "gives you a feeling of pleasure."

Pfizer should take advantage of the vivid, Chantix-induced dreams/hallucinations reported by patients and redesign their ads with that in mind. Find out more about that here: Chantix Californication Dreamin'

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