Chantix Label Revision

Sadaka Associates — Wed, 27 Feb 2008 06:25:56 +0000

FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

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Sadaka Associates — Wed, 06 Feb 2008 03:47:01 +0000

Many new drugs initially enjoy banner sales growth, only to get kneecapped by reports of previously unknown adverse side effects. On Friday, the FDA issued an alert “highlighting” a stricter warning label for one of Pfizer‘s most important new drugs.

The compound in question, Chantix, is one of the most recent non-nicotine stop-smoking treatments on the market. The FDA approved it back in 2006, but after its launch, some of the more than 5 million patients who have tried the drug began to report adverse events, including anxiety, other serious psychiatric changes, and “vivid” and “unusual” dreams. As a result of these reports, Pfizer strengthened the warning label for Chantix. Last week’s FDA announcement formalized more specific safety warnings for the drug’s label.

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Chantix Label Revision

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