Rofecoxib

VioxxVioxx (Rofecoxib)
Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).wikipedia
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Nonsteroidal anti-inflammatory drug

NSAIDNSAIDsnon-steroidal anti-inflammatory drug
Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).
Rofecoxib (Vioxx) was shown to produce significantly fewer gastrointestinal adverse drug reactions (ADRs) compared with naproxen.

Merck & Co.

MerckMerck & CoMerck & Co., Inc.
It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea.
In 2005, CEO Raymond Gilmartin retired following Merck's voluntary worldwide withdrawal of Vioxx.

Osteoarthritis

arthrosisdegenerative joint diseaseKnee osteoarthritis
It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea.
The COX-2 selective inhibitor rofecoxib was removed from the market in 2004, as cardiovascular events were associated with long term use.

Eric Topol

Eric J. Topol
Renowned research cardiologist Eric Topol, a prominent Merck critic, accused Merck of "manipulation of data" and said "I think now the scientific misconduct trial is really fully backed up".
Topol was one of the first researchers to question the cardiovascular safety of rofecoxib (Vioxx), culminating in the drug's ultimate withdrawal from the market.

Celecoxib

Celebrex
On March 11, 2009, Scott S. Reuben, former chief of acute pain at Baystate Medical Center, Springfield, Mass., revealed that data for 21 studies he had authored for the efficacy of the drug (along with others such as celecoxib) had been fabricated in order to augment the analgesic effects of the drugs.
The COX-2 inhibitor rofecoxib (Vioxx) was removed from the market in 2004 due to its risk.

Scott Reuben

Scott S. Reuben
On March 11, 2009, Scott S. Reuben, former chief of acute pain at Baystate Medical Center, Springfield, Mass., revealed that data for 21 studies he had authored for the efficacy of the drug (along with others such as celecoxib) had been fabricated in order to augment the analgesic effects of the drugs.
The hospital asked the journals to retract the studies, which reported favorable results from painkillers including Pfizer Inc.'s Bextra, Celebrex and Lyrica and Merck & Co. Inc.'s Vioxx.

Cyclooxygenase

COXcyclooxygenase 1cyclo-oxygenase
Cyclooxygenase (COX) has two well-studied isoforms, called COX-1 and COX-2.
Rofecoxib (brand name Vioxx) was withdrawn in 2004 because of such concerns.

Edward Scolnick

Edward M. ScolnickEdward M. Scolnick Prize in Neuroscience
Investigations revealed that Merck had several years worth of information suggesting an elevated risk of cardiac events, and Vice President Edward Scolnick took much of the blame for the suppression of this information.
He was a key figure in the development and marketing of Vioxx, which was pulled from the market after it was discovered that the drug caused a dangerously high risk of myocardial infarction.

The New England Journal of Medicine

New England Journal of MedicineNEJMBoston Medical and Surgical Journal
Months after the preliminary version of VIGOR was published in the New England Journal of Medicine in November 2000, the journal editors learned that certain data reported to the FDA were not included in the NEJM article.
In the early 2000s, The New England Journal of Medicine was involved in a controversy around problems with research on the drug Vioxx.

Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
The results of the VIGOR study were submitted to the United States Food and Drug Administration (FDA) in February 2001.
The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels.

Aspirin

acetylsalicylic acidBufferinASA
Some commentators have noted that naproxen would have to be three times as effective as aspirin to account for all of the difference, and some outside scientists warned Merck that this claim was implausible before VIGOR was published.
However, several of the new COX-2 inhibitors, such as rofecoxib (Vioxx), have been withdrawn in the last decade, after evidence emerged that PTGS2 inhibitors increase the risk of heart attack and stroke.

Diclofenac

diclofenac sodiumVoltarenCambia
It is only with the recent development of drugs like Vioxx that drug companies have carried out the kind of well executed trials that could establish such effects and these sort of trials have never been carried out in older "trusted" NSAIDs such as ibuprofen, diclofenac and others.
Following the identification of increased risks of heart attacks with the selective COX-2 inhibitor rofecoxib in 2004, attention has focused on all the other members of the NSAIDs group, including diclofenac.

COX-2 inhibitor

COX-2 selective inhibitorCOX-2 inhibitorsCOX inhibitor
Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).
Targeting selectivity for COX-2 reduces the risk of peptic ulceration and is the main feature of celecoxib, rofecoxib, and other members of this drug class.

Class action

class action lawsuitclass-action lawsuitclass-action
By March 2006, there were over 10,000 cases and 190 class actions filed against Merck over adverse cardiovascular events associated with rofecoxib and the adequacy of Merck's warnings.
However, in the Vioxx litigation, two provincial courts recently certified overlapping class actions whereby Canadian residents are class members in two class actions in two provinces.

Eldon E. Fallon

Eldon Fallon
Judge Eldon E. Fallon of the United States District Court for the Eastern District of Louisiana additionally ordered the plaintiff lawyers to cap their fees at 32% of the settlement amount.
Referred as a pioneer in the creative use of multidistrict litigations and bellwether trials, Fallon has overseen several high-profile multidistrict litigation cases in recent years, including the Xarelto, Chinese Drywall, Vioxx, and Propulsid litigations.

Discovery and development of cyclooxygenase 2 inhibitors

Discovery and development of COX-2 selective inhibitorsCyclooxygenase 2 inhibitors
It took less than eight years to develop and market the first COX-2 inhibitor, with Celebrex (celecoxib) launched in December 1998 and Vioxx (rofecoxib) launched in May 1999.

David Graham (epidemiologist)

David Graham
On November 18, 2004, Dr. Graham testified before the U.S. Senate Committee on Finance about Merck's withdrawal of the popular anti-inflammatory drug Vioxx the previous month because of serious safety concerns.

Pain

physical painacute painnociceptive pain
It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea.

Dysmenorrhea

dysmenorrhoeamenstrual crampspainful menstruation
It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea.

Medical prescription

prescriptionprescriptionsprescribed
Rofecoxib was available by prescription in both tablet-form and as an oral suspension.

Myocardial infarction

heart attackheart attacksacute myocardial infarction
In September 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.

Haemophilia

hemophiliahemophiliachaemophiliac
In November 2017, Massachusetts-based Tremeau Pharmaceuticals announced its plan to return rofecoxib (TRM-201) to market as a treatment for hemophilic arthropathy (HA).

Prostaglandin

prostaglandinsprostoglandinprostaglandins a
COX-1 mediates the synthesis of prostaglandins responsible for protection of the stomach lining, while COX-2 mediates the synthesis of prostaglandins responsible for pain and inflammation.

Naproxen

Alevenaproxen sodiumAnaprox
This was largely based on the VIGOR (Vioxx GI Outcomes Research) study, which compared the efficacy and adverse effect profiles of rofecoxib and naproxen.

Acne

acne vulgariscystic acneAcne scarring
A 2003 placebo-controlled small short-term study in India of 80 women with premenstrual acne vulgaris acne, were given rofecoxib or placebo for 2 cycles of 10 days suggest that "rofecoxib is effective in the management of premenstrual acne.