Bextra Lawyer, Lawyers, Attorney, Attorneys, Law, Legal Court Cases

What is Bextra?

Valdecoxib is a prescription drug used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory drug, or NSAID, and should not be taken by anyone allergic to these types of medications.

Valdecoxib was manufactured and marketed under the brand name Bextra® by G. D. Searle & Company. It was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke.

Side effects and withdrawals of Bextra.

On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck's Vioxx. Other reported side-effects were angina and Stevens-Johnson syndrome.

Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.

Personal injury related to Bextra.

With the removal of the drug from the market, there is expected to be a surge in personal injury claims, many in the form of class action, to seek compensation.

tFDA Alert [4/7/2005]:

FDA has requested that Pfizer voluntarily withdraw Bextra from the United States market. Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussion with the Agency. At this time, the Agency has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.

Recommendations

* FDA recommends that patients being treated with Bextra be switched to an alternative therapy.

Data Summary

* Bextra has been demonstrated to be associated with an increased risk of serious adverse CV events in two short-term trials in patients immediately post-operative from coronary artery bypass graft (CABG) surgery. Data are not available from long-term controlled clinical trials to evaluate the cardiovascular safety of Bextra following chronic use. FDA has concluded that it is reasonable to extrapolate the adverse CV risk information for Bextra from the short-term CABG trials to chronic use given the fact that other COX-2 selective NSAIDs have been shown in long-term controlled clinical trials to be associated with an increased risk of serious adverse CV events (e.g., death, MI, stroke), and the well described risk of serious, and often life-threatening gastrointestinal bleeding.

* Bextra is a sulfonamide and already carries a boxed warning in the package insert for serious and potentially life-threatening skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme). The reporting rate to FDA’s spontaneous reporting system for these serious skin reactions is significantly greater for Bextra than other COX-2 selective agents. The risk of these serious skin reactions in individual patients is unpredictable, occurring in patients with and without a history of sulfa allergy, and after both short- and long term use.

* To date, there have been no studies that demonstrate an advantage of Bextra over other NSAIDs that might offset the concern about these serious skin risks, such as studies that show a GI safety benefit, better efficacy compared to other products, or efficacy in a setting of patients who are refractory to treatment with other products.

* Extensive data related to the cardiovascular safety of Bextra and other COX-2 selective and non-selective NSAIDs were presented at the Joint Meeting on February 16, 17, and 18, 2005, of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This information is available on the following website: http://www.fda.gov/ohrms/dockets/ac/cder05.html#ArthritisDrugs

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Issues Surrounding Bextra Arthritis Drug

Bextra
is once a popular drug for arthritis. But when the US FDA had ordered its pullout, it ceased to be the wonder drug that it used to. Bextra is considered as an NSAID drug. NSAID means non-steroidal anti-inflammatory drug. These drugs are commonly used by arthritis patients and those who experience severe pain in their muscles and joints. Pharmacia Corporation manufactured Bextra but it was chiefly distributed by Pfizer. Bextra's generic name is Valdecoxib. It works as a powerful painkiller and can provide an almost immediate relief to arthritis patients.

However, the pullout of Bextra from pharmacies is due to its side effects. It was found out that Bextra can cause skin reactions that can be fatal to patients who use it regularly. Because of this, the US Food and Drug Administration had publicly announced that the drug is not fit for use and issued its recall. Pfizer, the drug's distributor, heeded the call and pulled their product out for the safety of the buying public. When the recall is issued, patients on Bextra are strongly advised to stop their intake of the drug and consult with their physicians immediately. The physicians, in turn, would have to give them the next best alternative for the drug.

Pfizer continued to study Bextra and what went wrong about it. Currently, they are trying to improve the drug so that its beneficial uses will not be overshadowed by its side effects. Aside from life-threatening skin reactions, it was also discovered that Bextra can cause cardiovascular diseases as well.

Bextra was initially created to aid osteoarthritis patients. This condition is a type of arthritis that is described as the overuse of the joints. The joints suffer from normal wear and tear throughout one's lifespan. However, other factors such as obesity and extraneous activities can also increase your risks of osteoarthritis. Bextra had effectively eliminated the stomach upsets normally associated to NSAIDs. However, it had overseen the adverse skin reaction it produces, including major heart concerns. If not for these, Bextra is very effective not only for osteoarthritis patients but for those who are suffering from rheumatoid arthritis and menstrual pains as well.

This development about the Bextra drug had caused a big impact on the public. As a result, they became even more concerned and confused as to which drug to trust. Even doctors were alarmed about it. Patients who are on constant medication became wary of their drug, even if it doesn't have any direct relation to Bextra or NSAIDs. This occurrence had placed the spotlight on alternative medicines, which claim to be all-natural and causes absolutely no side effects. However, there are also a group of patients who choose not to take medicines at all but simply withstand the pain of their condition.

Whether or not Bextra had affected the confidence of patients with their drugs, the problem with side effects still remains. It is impossible to assess the effectiveness of certain drugs on your health problem without taking it first. This is the reason why the use of natural and alternative medicines had risen over time.

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Part 2 - For part two of this article, head on to http://www.psoraticarthritisreview.com where you can also find the truth about natural arthritis pain relief and herbal treatment for arthritis.

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