Re: How rational are COX 2 inhibitors

[Guest guest]

Dear members,

On September 30, 2004, the United States Food and Drug Administration announced that Merck and Company was withdrawing rofecoxib from the market, based on evidence from long-term studies showing that the drug had a higher risk of cardiovascular problems than comparable agents.

On April 7, 2005, the Food and Drug Administration asked Pfizer to withdraw valdecoxib from the market. Valdecoxib had been approved for treatment of rheumatoid and osteoarthritis and for primary dysmenorrhea. The FDA recommendation for the discontinuation of valdecoxib was based on cardiovascular risk particularly in patients who had undergone cardiovascular surgery and relative frequency of rare but very severe skin reactions, including Syndrome and toxic epidermal necrolysis .This potentially fatal adverse reaction is seen with many drugs , but according to the FDA was observed disproportionately frequently with valdecoxib Regards,Dr. K. M. Jaiswal.Lecturer, Dept. of PharmacologyGMC, Nagpur.

From: Kavita Jaiswal <kp_jaiswal@...>netrum <netrum >Sent: Mon, 14 February, 2011 1:19:32 PMSubject: How rational are COX 2 inhibitors

Dear Members,The development of the -2 selective inhibitors was intended to provide drugs that would offer the same pain relieving and anti-inflammatory effects as the traditional NSAIDs without causing the gastric ulcers that have been associated with the older drugs.Available coxibs include celecoxib, etoricoxib (Arcoxia), and parecoxib.

Dr. K. Jaiswal

Lecturer, Dept of Pharmacology.GMC, Nagpur

[Guest guest]

Dear members,The main reasons for the removal of rofecoxib and valdecoxib from the market was that they were found to

cause an increase in cardiovascular

problems for long term users (i.e. heart attacks and strokes), it

was reported that the risks for patients using these drugs were 2 to 3 times

greater than for those who were given a placebo. The reason for the delay in

identifying the risks with these drugs was that effects only became noticeable

after 18 months use.The FDA decided that celecoxib would be allowed to remain on the market with the

provision that it contained a “black box†warning about cardiovascular risks.

Regards,Dr. K. M. Jaiswal.Lecturer, Dept. of PharmacologyGMC, Nagpur.From: Kavita Jaiswal <kp_jaiswal@...>netrum Sent: Tue, 15 February, 2011 12:17:50 PMSubject: Re: How rational are COX 2 inhibitors

Dear members,

On September 30, 2004, the United States Food and Drug Administration announced that Merck and Company was withdrawing rofecoxib from the market, based on evidence from long-term studies showing that the drug had a higher risk of cardiovascular problems than comparable agents. On April 7, 2005, the Food and Drug Administration asked Pfizer to withdraw valdecoxib from the market. Valdecoxib had been approved for treatment of rheumatoid and osteoarthritis and for primary dysmenorrhea. The FDA recommendation for the discontinuation of valdecoxib was based on cardiovascular risk particularly in patients who had undergone cardiovascular surgery and relative frequency of rare but very severe skin reactions, including Syndrome and

toxic epidermal necrolysis .This potentially fatal adverse reaction is seen with many drugs , but according to the FDA was observed disproportionately frequently with valdecoxib Regards,Dr. K. M. Jaiswal.Lecturer, Dept. of PharmacologyGMC, Nagpur.

From: Kavita Jaiswal <kp_jaiswal@...>netrum <netrum >Sent: Mon, 14 February, 2011 1:19:32 PMSubject: How rational are COX 2 inhibitors

Dear Members,The development of the -2 selective inhibitors was intended to provide drugs that would offer the same pain relieving and anti-inflammatory effects as the traditional NSAIDs without causing the gastric ulcers that have been associated with the older drugs.Available coxibs include celecoxib, etoricoxib (Arcoxia), and parecoxib.

Dr. K. Jaiswal

Lecturer, Dept of Pharmacology.GMC, Nagpur

[Guest guest]

Dear members,Series of restrictions and special considerations were announced by the FDA to regulate the use of these COX-2

inhibitors in light of the risk of cerebrovascular events.

In February 2005, an FDA release directed the Pfizer, Inc. to withdraw valdexocib

from the market, as the overall risks factors were far more than the potential

benefits of the drug.

In addition, the statement also directed Pfizer, Inc. to include a boxed

warning in the celecoxib label.

Consequently, the Pfizer, Inc. agreed to suspend sales and marketing of

valdecoxib in the US

and work with the FDA on the boxed warning required on the packaging of

celecoxib.

Finally, the FDA also issued supplemental request letters to sponsors of all

COX-2 Inhibitors to revise the labeling for their products. The revised

labeling or packaging insert is required to include a boxed warning

highlighting the potential for increased risk of cardiovascular events and life-threatening

gastrointestinal bleeding associated with their use.

After the withdrawal of valdecoxib and rofecoxib from the market, Pfizer has

now placed the following warning on celecoxib label:

Important Information: CELEBREX(celecoxib) may increase the chance of a

heart attack or stroke that can lead to death. It should not be used right

before or after certain heart surgeries. Serious skin reactions or stomach

problems such as bleeding can occur without warning and may cause death.

Regards,Dr. K. M. Jaiswal.Lecturer, Dept. of PharmacologyGMC, Nagpur.From: Kavita Jaiswal <kp_jaiswal@...>netrum <netrum >Sent: Mon, 14 February, 2011 1:19:32 PMSubject: How rational are COX 2 inhibitors

Dear Members,The development of the -2 selective inhibitors was

intended to provide drugs that would offer the same pain relieving and

anti-inflammatory effects as the traditional NSAIDs without causing the gastric

ulcers that have been associated with the older drugs.Available coxibs include celecoxib,

etoricoxib (Arcoxia), and parecoxib.

Dr.

K. Jaiswal

Lecturer,

Dept of Pharmacology.

GMC, Nagpur