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.
Additional Information on Bextra
Bextra is contraindicated in patients who have demonstrated allergic-type reactions to sulfonamides; in patients with known hypersensitivity to valdecoxib; and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs because severe, rarely fatal, anaphylactic-like reactions to NSAIDS are possible in such patients. In rare cases, serious skin reactions can occur. Fatalities due to Stevens- Johnson syndrome and toxic epidermal necrolysis have been reported. If an allergic reaction is suspected or if there are other severe or unusual symptoms while taking Bextra, a patient should call his or her doctor or other healthcare professional immediately.
DISCLOSURE NOTICE: The information contained in this document is as of November 10, 2004. Pfizer assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments.
This document contains forward-looking information. A list and description of risks and uncertainties relating to matters discussed in this document can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and in its periodic reports on Forms 10-Q and 8-K.
(1) White WB, et al. "Effects of the Cyclooxygenase-2 Specific Inhibitor Valdecoxib Versus Nonsteroidal Antiinflammatory Agents and Placebo on Cardiovascular Thrombotic Events in Patients with Arthritis." American Journal of Therapeutics. 2004; 11: 244-250. Number 4.
Heart attack and stroke two of leading causes of death and disability around the world. Clearly, not enough people know about the risks and factors surrounding these two medical emergencies. For example, many thought that as long as they do not smoke, consume too much alcohol, and regularly have exercise they would be immune from this killer disease. However, a number of individuals fail to watch their diet, which is sometimes composed of fatty foods and fast food orders. These facts should not be taken for granted. Read on to find ways to protect yourself and loved ones from this dreaded disease.
A heart attack develops when an artery become blocked, therefore preventing blood that carries oxygen and essential nutrients from reaching the heart. With insufficient oxygen supply, an area of the heart or is permanently damaged. Some heart attacks are abrupt and severe but most cases develop slowly, usually with slight pain or discomfort. Individuals that are affected may not be sure of the symptoms and they seek medical attention when it's already too late.
The following are possible warning signs that can mean a heart attack is taking place:
Discomfort at the center of the chest that may lasts more than a few minutes. This may feel like squeezing pain that goes away and then comes back; Discomfort or pain in the areas of the upper body like the jaw, neck, one or both arms, stomach, or back; Shortness of breath that may take place with or without chest pains; and Cold sweat, cough, nausea, vomiting, light-headedness, and fainting.
Stroke or ?brain attack? occurs because of the absence of blood flow to the brain (ischemic stroke) and, in some cases, there is bleeding in the brain (hemorrhagic stroke). According to medical experts, blood vessels in the brain are damaged because if fat deposits or blood clot that may block a part of the brain. With insufficient blood that carries oxygen and nutrients, brain cells die and cause permanent damage.
The warning signs of stroke include:
Numbness or weakness in the face, arm or leg. These numbness usually occur in one side of the body; Severe headache with unknown cause; Swallowing difficulties or drooling; Uncontrollable eye movements, eyelid drooping; Loss of balance or coordination; and Personality changes, like depression.
Individuals who experience these signs, they should act fast and go to the hospital immediately. Getting urgent treatment may save the victim's life and reduce the chances of developing disability. Medical specialists advice patients to receive therapy three hours after the stroke. Stroke should be treated with intensive care and life support that only hospitals can support.
A healthy lifestyle is crucial in the prevention of heart attack and stroke. Some factors that may contribute to the risks of stroke include age, family history of stroke, high cholesterol, smoking, and diabetes. In addition to these risks, alcohol and drug abuse, head injury, and bleeding disorder may increase the risks of stroke.
The possibility of recovering most or all of body functions of those who survived from stroke is only 10 percent. Most even experience long-term disabilities. Therefore, the best immunity when it comes to stroke is having a healthy and active lifestyle.
Both Michael Monheit, Esquire, Monheit Law, Pc & Emmanuel Chavez are contributors for EditorialToday. The above articles have been edited for relevancy and timeliness. All write-ups, reviews, tips and guides published by EditorialToday.com and its partners or affiliates are for informational purposes only. They should not be used for any legal or any other type of advice. We do not endorse any author, contributor, writer or article posted by our team.
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