PharmExec Blog

Pfizer Responds to Adverse Events Report

A report released last week by the The Institute for Safe Medication Practices (and covered yesterday on PharmExec.com), listed Pfizer’s smoking cessation drug Chantix as the number one most reported drug for adverse reactions in the first quarter of 2008.

The report states that FDA received 1,001 reports of serious side effects for varenicline (the generic form of Chantix). That’s significantly more adverse events than heparin, which rang up only 779 reactions (and allegedly killed a few people).

Chantix gartered a ton of headlines during that same period. In January 2008, Pfizer pumped up the warnings on the drug to include suicidal thinking and depression. It is possible that the undo attention could have increased the rate of adverse reaction reporting. ISMP said that it made a point to weed out all the minor reports or possible fakes.

Initial calls to Pfizer weren’t returned, but the company’s PR team gave a ring this morning to let me know that a statement was on its way. Here’s what Pfizer spokesperson Sally Beatty had to say:

There is nothing new about this data. In fact, the number of monthly serious adverse events for Chantix has been decreasing after a peak in January. In fact, ISMP presents no evidence that smokers taking Chantix experience more accidents and injuries than those who haven’t used Chantix to help them quit smoking.

The totality of available data, which are based on complete and current information, reveal no greater frequency of accidents and injuries reported with Chantix than with other medications.

While we welcome ongoing debate on the epidemic of tobacco addiction, we believe that framing that debate in the right context is in the best interest of public health. As part of Pfizer’s commitment to medication safety, Pfizer recently launched a Medicine Safety Education website that describes how safety is evaluated throughout the lifecycle of medications at www.Pfizer.com/medicinesafety.

I guess we’ll just have to wait and see what the next quarterly report from ISMP has to say.

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2 Comments

  1. someguy
    Posted October 30, 2008 at 8:35 am | Permalink

    It’s interesting that Pfizer responds with such vague counterpoints. “In fact, ISMP presents no evidence that smokers taking Chantix experience more accidents and injuries than those who haven’t used Chantix to help them quit smoking.”

    What does this mean, exactly? Because the report specifically reports far lower numbers for injuries related to Zyban and nicotine replacement products (44 and 17, respectively).

    Also, “The totality of available data, which are based on complete and current information, reveal no greater frequency of accidents and injuries reported with Chantix than with other medications.” What data are they talking about, specifically? Because, again, the report showed that Chantix received almost twice the number of Heparin, which was number two on the list. And Heparin was contaminated with a lethal bacteria during the period covered.

  2. anotherguy
    Posted November 17, 2008 at 7:59 pm | Permalink

    the answer is already here:

    you can see Q2 2008 data for chantix here:

    http://www.fdable.com/aers/advanced_query/424c4cb00

    Q1 2008 Chantix data can be seen with this query: http://www.fdable.com/aers/advanced_query/d55bb0233

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