Pfizer reacts with a Press Release, rather than a warning about strokes and heart attacks. Written by Michael Monheit, Esquire, Monheit Law, PC
Want to know what Pfizer is saying about article linking its drug Bextra to strokes and heart attacks? Consider that Pfizer is selling $600,000,000 worth of 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 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, White et al. analysis published earlier this year in 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 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 United States." This communication included information regarding White analysis as well as results of studies in several surgical settings. As previously announced, Pfizer has committed to conducting further studies to confirm longer-term cardiovascular safety profile of Bextra in patients who require chronic treatment for arthritis with a COX-2-specific inhibitor.
| | Medical Information about Bextra Written by Michael Monheit, Esquire, Monheit Law, PC
Medical Information Bextra can cause extreme side effects, including (but not limited to) following:Anaphylaxis is a sudden, severe, potentially fatal, systemic allergic reaction involving various areas of body such as skin, respiratory tract, gastrointestinal tract, and cardiovascular system. Unlike Stevens Johnson Syndrome, these symptoms occur within minutes and up to two hours after contact with allergy-causing substance, but in rare instances may occur up to four hours later. Angioedema refers to swelling that occurs in tissue just below surface of skin. It generally results from an allergic reaction to either a food or medication. It may be a sign of an underlying condition such as leukemia or Hodgkin's disease. This is often associated with Stevens Johnson syndrome. Toxic Epidermal Necrolysis is a life-threatening skin disorder characterized by blistering and peeling of top layer of skin. This disorder can be caused by a drug reaction to penicillin but has now been linked to Bextra. Erythema Multiforme (EM) is an acute self-limited eruption characterized by a distinctive clinical eruption, hallmark of which is iris or target lesion. EM may be present within a wide spectrum of severity. EM minor represents a localized eruption of skin with mild or no mucosal involvement, corresponding to initial description of von Hebra. EM major and Stevens Johnson syndrome (SJS) are more severe mucosal and skin diseases as well as potentially life-threatening disorders.
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