| Want to know what Pfizer is saying about the article | | | | COX-2-specific inhibitor. |
| linking its drug Bextra to strokes and heart attacks? | | | | The Food and Drug Administration plans to convene |
| Consider that Pfizer is selling $600,000,000 worth of | | | | an advisory committee in February 2005 to review |
| the drug, and then see what they have to say | | | | the cardiovascular safety of all COX-2 inhibitors. "We |
| below. | | | | look forward to a scientific and reasoned evaluation |
| Pfizer Statement on Bextra(R) (Valdecoxib) | | | | in this appropriate setting," Dr. Feczko said. |
| Wednesday November 10, 1:55 pm ET | | | | Additional Information on Bextra |
| NEW YORK, Nov. 10 /PRNewswire-FirstCall/ -- Pfizer | | | | Bextra is contraindicated in patients who have |
| Inc said a New York Times article published today | | | | demonstrated allergic-type reactions to sulfonamides; |
| draws unsubstantiated conclusions about the | | | | in patients with known hypersensitivity to valdecoxib; |
| cardiovascular safety of its COX-2 medicine Bextra | | | | and in patients who have experienced asthma, |
| and is based on information that has not been | | | | urticaria, or allergic-type reactions after taking aspirin |
| published in a medical journal or subject to | | | | or NSAIDs because severe, rarely fatal, |
| independent scientific review. In contrast, the White | | | | anaphylactic-like reactions to NSAIDS are possible in |
| et al. analysis published earlier this year in the | | | | such patients. In rare cases, serious skin reactions can |
| peer-reviewed American Journal of Therapeutics(1) | | | | occur. Fatalities due to Stevens- Johnson syndrome |
| stated that short-and intermediate-term treatment | | | | and toxic epidermal necrolysis have been reported. If |
| with Bextra was not associated with an increased | | | | an allergic reaction is suspected or if there are other |
| incidence of thrombotic events relative to | | | | severe or unusual symptoms while taking Bextra, a |
| nonselective NSAIDs or placebo in osteoarthritis and | | | | patient should call his or her doctor or other |
| rheumatoid arthritis patients. This conclusion was | | | | healthcare professional immediately. |
| based on evaluation of a clinical trials database that | | | | DISCLOSURE NOTICE: The information contained in |
| includes nearly 8,000 patients treated with Bextra for | | | | this document is as of November 10, 2004. Pfizer |
| durations ranging from 6 to 52 weeks. | | | | assumes no obligation to update any forward-looking |
| "Pfizer has shared Bextra clinical results in a timely | | | | statements contained in this document as a result of |
| manner with regulatory authorities both in the United | | | | new information or future events or developments. |
| States and worldwide," said Joseph Feczko, MD, | | | | This document contains forward-looking information. |
| Pfizer's president of worldwide development. "In | | | | A list and description of risks and uncertainties relating |
| addition, in an October 15 communication, a | | | | to matters discussed in this document can be found |
| comprehensive summary of currently available data | | | | in the Company's Annual Report on Form 10-K for |
| was provided to healthcare professionals in the | | | | the fiscal year ended December 31, 2003, and in its |
| United States." This communication included | | | | periodic reports on Forms 10-Q and 8-K. |
| information regarding the White analysis as well as | | | | (1) White WB, et al. "Effects of the |
| the results of studies in several surgical settings. As | | | | Cyclooxygenase-2 Specific Inhibitor Valdecoxib |
| previously announced, Pfizer has committed to | | | | Versus Nonsteroidal Antiinflammatory Agents and |
| conducting further studies to confirm the longer-term | | | | Placebo on Cardiovascular Thrombotic Events in |
| cardiovascular safety profile of Bextra in patients | | | | Patients with Arthritis." American Journal of |
| who require chronic treatment for arthritis with a | | | | Therapeutics. 2004; 11: 244-250. Number 4. |