Pfizer reacts with a Press Release, rather than a warning about strokes and heart attacks. by Michael Monheit, Esquire, Monheit Law, PC

Want to know what Pfizer is saying about the article linking its drug Bextra to strokes and heart attacks? Consider that Pfizer is selling $600,000,000 worth of the drug, and then see what they have to say below.

Pfizer Statement on Bextra(R) (Valdecoxib) Wednesday November 10, 1:55 pm ET

NEW YORK, Nov. 10 /PRNewswire-FirstCall/ -- Pfizer Inc said a New York Times article published today draws unsubstantiated conclusions about the cardiovascular safety of its COX-2 medicine Bextra and is based on information that has not been published in a medical journal or subject to independent scientific review. In contrast, the White et al. analysis published earlier this year in the peer-reviewed American Journal of Therapeutics(1) stated that short-and intermediate-term treatment with Bextra was not associated with an increased incidence of thrombotic events relative to nonselective NSAIDs or placebo in osteoarthritis and rheumatoid arthritis patients. This conclusion was based on evaluation of a clinical trials database that includes nearly 8,000 patients treated with Bextra for durations ranging from 6 to 52 weeks.

"Pfizer has shared Bextra clinical results in a timely manner with regulatory authorities both in the United States and worldwide," said Joseph Feczko, MD, Pfizer's president of worldwide development. "In addition, in an October 15 communication, a comprehensive summary of currently available data was provided to healthcare professionals in the United States." This communication included information regarding the White analysis as well as the results of studies in several surgical settings. As previously announced, Pfizer has committed to conducting further studies to confirm the longer-term cardiovascular safety profile of Bextra in patients who require chronic treatment for arthritis with a COX-2-specific inhibitor.

The Food and Drug Administration plans to convene an advisory committee in February 2005 to review the cardiovascular safety of all COX-2 inhibitors. "We look forward to a scientific and reasoned evaluation in this appropriate setting," Dr. Feczko said.

Go to Page 2

BIO:

Michael Monheit, Esquire is the managing attorney for Monheit Law, located in Philadelphia, Pennsylvania Monheit Law, P.C. concentrates its practice in the field of plaintiff personal injury cases on a contingency fee basis. They can be found at http://www.monheit.com/Bextra

Some Aditional Articles you may enjoy

How to Have Your Greatest Orgasm -- Ever by by Jane L. Jarvis and R. G. Edgar

End Winter Weight Gain With Healthy Snacking by Kathryn Martyn, M.NLP

Support Breast Cancer Foundation by Barbara Mascio

What about Juan Valdez? by Iulia Pascanu

Tips to Achieve Your Optimal Body Shape by Cheryl Haining

Click a Number to go to an article index page
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39