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E-Articles - Bextra and Other Cox-2 Inhibitors Can Cause Serious Problems
Also known under the name of valdecoxib, Bextra is used in the treatment of pain, swelling, and tenderness, caused by osteoarthritis and adult rh
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
eumatoid arthritis.
This drug belongs to a class of nonsteroidal anti-inflammatory medications, which are named COX-2 inhibitors. Bextra’s role
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
s to block the action of the COX-2 enzyme, because it is known that inflammation and arthritis pain are caused by that enzyme’s action.
There ar
There ar
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e side effects that Bextra produces. We can mention a few of them: back pain, headache, stomach pain, diarrhea, nausea, upper respiratory infect
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
on, and heartburn, but it is good to know that these are not all the side effects this drug can provoke.
There are also known some hypersensitiv
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ty reactions and skin reactions that appeared in postmarketing experience. We can include here anaphylactic reactions and angioedema as hypersens
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
itivity reactions, and skin reactions like toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and cases of Stevens-Johnson
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
yndrome.
Among these cases, some were really serious, and they occurred in some patients that had history of allergic reactions to sulfonamides,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
but also in others that hadn’t.
Soon after Vioxx, a similar cox-2 inhibitor was withdrew from the market because it was shown that it increases
Soon after Vioxx, a similar cox-2 inhibitor was withdrew from the market because it was shown that it increases
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
the risk of cardiovascular events, the Bextra’s producer discovered that some heart bypass surgery patients taking Bextra presented increased ris
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of heart attack and stroke.
Some scientists performed investigations and they reached the conclusion that among the patients that used Bextra
Some scientists performed investigations and they reached the conclusion that among the patients that used Bextra
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the number of heart attacks and strokes was more than double compared to the group of patients that used a placebo.
Bextra is responsible of som
Bextra is responsible of som
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
other side-effects too. It was found that this drug triples the incidence of heart attack and stroke in coronary bypass graft surgery patients.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Studies revealed that Bextra, and other cox-2 inhibitors - Celebrex and Vioxx develop an increased risk of heart attack or stroke in patients th
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
t are using them. The results of the studies, determined that patients using Bextra have a risk of heart attack 53% higher than normal, 23% high
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
r have the patients that take Vioxx, and 19% higher then normal have those who take Celebrex.
Vioxx is no longer for sale, it was recalled in S
Vioxx is no longer for sale, it was recalled in S
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
eptember 2004, and in April 2005, it was decided that Bextra must be withdrawn, because the risks this drug provoke are much to big than the pote
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tial benefit.
It is very important to contact your doctor if you think you are experiencing side effects because of Bextra. You should also disc
It is very important to contact your doctor if you think you are experiencing side effects because of Bextra. You should also disc
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
uss with your doctor about this drug, about the risks that may occur, and about the benefits this drug can bring.
If you experienced very seriou
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
and grave side effects, you can ask help from a lawyer, and he will help you to protect your rights and get compensations from the drug producer
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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