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FDA releases Champix warning

The FDA has expressed concerns regarding Pfizer's smoking cessation drug Champix.

The FDA has expressed concerns regarding Pfizer's smoking cessation drug Champix (varenicline).

The US agency released an "early communication", which warned of reports of erratic behaviour in patients prescribed Chantix, as it is known in the US. An early communication represents a review and analysis of available data.

Pfizer submitted reports to the FDA describing suicidal thoughts and erratic behaviour in one person who had used Champix, along with at least one death possibly linked to the drug.

The FDA conceded that other factors, including alcohol consumption, appear to have had an impact in this specific case, and the agency asked Pfizer for additional similar cases.

The FDA is also investigating cases of Champix patients experiencing excessive drowsiness which affected their ability to drive or operate machinery. It is asking doctors to monitor Champix patients for mood stability and patients to take care while driving or operating machinery.

The "early communication" does not mean that the FDA has ruled there is a relationship between the drug and the emerging safety concerns, but rather that it is evaluating post-marketing adverse event reports.

The FDA itself has advised doctors to closely monitor patients taking Champix for behaviour and mood changes in patients within days or weeks of starting treatment. The agency has also advised patients to use caution when driving or operating machinery.

Pfizer says adverse event reports following a drug's approval are voluntarily submitted to companies by consumers and doctors and are not a reliable indicator of any potential safety problem.

In September 2007, Pfizer launched a direct-to-consumer (DTC) campaign in the US aimed at further increasing awareness of Champix and how it can help smokers who want to quit.

Champix racked up sales of USD 241m in Q3 FY07, compared with USD 33m in Q3 FY06.

Pfizer's shares dropped USD 0.29 below the 20 November opening price on the FDA warning in afternoon trading, but rose USD 0.01 to close at USD 22.72.

Celebrex plaintiff evidence submissions fail
In better news for Pfizer, a US District Court judge ruled on 19 November that plaintiffs had not submitted scientifically reliable evidence that Celebrex (celecoxib) causes heart attacks or strokes at the recommended dosage of 200 mg.

The judge's ruling could now limit the number of lawsuits Pfizer would face in federal court.

Approximately 3,000 plaintiffs have claimed a link between Celebrex and health problems, and up to 1,000 of these were taking the drug at the 200 mg level or less, according to a lawyer for the plaintiffs.

30th September 2008

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