Vioxx - Get the History of the Major Drug Recall
Vioxx Recall History - Learn how Vioxx rose from the idea of a Cox-2 specific inhibitor and how Vioxx fell when Merck issued a Vioxx Recall.
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1991: Discovery of Two Cyclooxygenase
Uncovered by two independent research groups, cyclooxygenase has two isoforms: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is the chief form of cyclooxygenase that regulates homeostatic conditions in the stomach, gastrointestinal tract, and kidneys and the effect for platelet aggregation. COX-2 is derived from COX-1 and catalyzes vasodilatation, inflammation, pain and anti-coagulant platelet effects.
COX-2 inhibitor race starts at Merck Frosst Centre for Therapeutic Research In the summer of 1992, Merck along with Pfizer-Pharmacia, DuPont and Taisho began research to create a drug that selectively inhibits the COX-2 isoform (the enzyme strictly responsible for inflammation and pain). With intensive research, scientists identified the compound L-745,337 and later two more compounds that had more promise as a COX-2 inhibitor, L-748,731 and L-748,706.
Internal office e-mail shows Merck may know Vioxx may cause an increase in blood clot side effects. Predicts new VIGOR study may “kill [the] drug.”
November 23, 1998
Merck submits the Vioxx New Drug Application (NDA)
January 1, 1999: Merck launches VIGOR study of Vioxx
May 20, 1999: Vioxx approved by the FDA: After 7 years of research and development, L-748,731, the compound that had no unusual expected toxicity was approved by the FDA in 12.5mg, 25mg and 50mg tablets and 12.5 mg/5mL oral suspension. The clinical trial of Vioxx® included more than 5000 patients and approved for diminishing pain in patients with acute and chronic osteoarthritis, adult pain relief and primary dysmenorrheal.
June 22, 1999
Dr. Peter Holt hired by Merck to promote the drug Vioxx to doctors. FDA finds Holt’s claims “false or misleading”.
November 18, 1999
Safety Monitoring Board raises concerns about “excess deaths and cardiovascular events” in the Merck’s VIGOR study on the drug Vioxx.
December 16, 1999
FDA claims some of Merck’s promotional information is “false or misleading because [it] contain[s] misrepresentations of Vioxx’s safety”. March 2000: Merck’s VIGOR study completed. Shows twice the rate of serious cardiovascular problems and five times the rate of heart attacks as compared to Naproxen.
June 2000: VIGOR results submitted to the FDA:
Results from the clinical trial VIGOR conducted by Merck & Co., Inc. were submitted and analyzed by the FDA. VIGOR [Vioxx GI Clinical Outcomes Research] was a study initiated by Merck & Co. Inc., in January 1999 to evaluate the incidences of GI events that included but were not limited to obstructions or bleeding (PUB) in the upper gastrointestinal tract. The study included 8076 patients of which 4047 were on 50mg twice daily of Vioxx and 4029 patients received naproxen 500mg twice daily. Compared to naproxen, Vioxx reduced 54% of serious gastrointestinal events and 57% of complicated gastrointestinal events. Even though it significantly reduced gastrointestinal events in comparison to naproxen, Vioxx also showed a significantly higher incidence of serious cardiovascular thrombotic events. The incidences occurred as soon as 4 months of chronic use of which there were 17 cardiovascular thrombotic adverse events. At the end of 8 and 10½ months there were 12 and 16 additional cardiovascular thrombotic events respectively. March 9, 2000: Internal office e-mail shows Merck is concerned about the study, saying cardiovascular problems “are clearly there”.
Study shows increased blood pressure in Vioxx patients compared to patients who took the drug Celebrex.
August 20, 2000
Merck attempts to refute evidence blood pressure side effects.
November 2000: VIGOR published in New England Journal of Medicine
Results showed to have increased cardiovascular events compared with the non-selective NSAID naproxen.
February 2001: Warning label required on Vioxx drug prescriptions
Arthritis Advisory Committee (AAC) meets regarding VIGOR Results and after extensive discussion over the cardiovascular events associated with the use of Vioxx, the Arthritis Advisory Committee recommends Merck & Co., Inc. add warning of the results to the drug’s label and to conduct more research to determine any remaining questions about the safety profile.
September 17, 2001: FDA sends Warning Letter to Merck & Co., Inc.
Thomas W. Abrams RPh., MBA, the director of the Division of Drug Marketing within the FDA issued a warning letter to President and CEO, Raymond V. Gilmartin of Merck & Co., Inc. to cease and remediate all promotional activities that have been falsified and misleading in regards to their blockbuster drug, Vioxx. The FDA found falsification and misrepresentation at 6 audio conferences by Peter Holt, MD, 1 press release “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx,” 22 May 2004, and in 3 oral presentations (1 at the Annual Meeting of the Maryland Pharmacists Association and 2 at the Annual Meeting of the American Society of Health-Systems Pharmacists).
January 15, 2002
Merck denies Vioxx safety issues in “Circulation” Magazine.
April 11, 2002: FDA Approves New Labeling for Vioxx
New Vioxx label includes results from VIGOR study and approved for Rheumatoid Arthritis.
2003: Merck reaches $2.5 Billion in Vioxx sales.
August 11, 2004: Dr. David Graham Vioxx side effects presentation
Vioxx patients have more than three times the heart attacks of Celebrex patients. FDA allegedly pressures Graham to soften his claims.
August 27, 2004: Release of APPROVe study: Affirms that Vioxx can triple heart attack risk.
September 30, 2004: Merck voluntarily recalls Vioxx
The External Data Monitoring Board for the clinical study APPROVe recommends to Merck & Co., Inc. about the increased cardiovascular risk of its drug. Merck voluntarily withdrew the drug and advised their patients to seek counsel from their physician about alternative medicines. The clinical studies were all terminated except for the Alzheimer trial currently being conducted by the University of Pennsylvania’s Alzheimer’s disease Center.
Oct. 29, 2004
Merck receives conditional approval from the FDA for Arcoxia, a cousin of Vioxx. However, this approval is contingent upon Merck completing more long-term safety and efficacy tests. At the time, Arcoxia is sold in 48 countries. Merck says it will work with regulators "to assess whether changes to the prescribing information for this class of drugs, including Arcoxia, are warranted." Merck continues to test and develop Arcoxia for the U.S. market.
Nov. 8, 2004
Merck reveals that its handling of Vioxx is being investigated by the Justice Department and by the Securities and Exchange Commission.
Nov. 18, 2004
The Senate Finance Committee holds a hearing on Merck and the FDA. Dr. David J. Graham, a veteran FDA researcher, accuses the agency of "a profound regulatory failure" in evaluating Vioxx that could easily be repeated with other drugs." Graham is the lead author of the FDA study that criticized Vioxx.
Dec. 23, 2004
The FDA issues a public health advisory urging doctors to weigh carefully the risks in prescribing medications for arthritis and pain, adding that they limit the use of medications known as Cox-2 inhibitors, which includes Vioxx and Pfizer's Celebrex and Bextra. The FDA urges patients to pay closer attention to the labels of certain over-the-counter medications for pain relief.
Feb. 7, 2005
In advance of three days of FDA advisory committee hearings on Cox-2 drugs and other painkillers, FDA staff members issue a report raising questions about two experimental Cox-2 drugs, Arcoxia from Merck and Prexige from Novartis (NVS:NYSE ADR - commentary - research - Cramer's Take). The two companies continue to test and develop their drugs for the U.S. market.
Feb. 18, 2005
An FDA advisory panel votes 17-15 that Vioxx could be returned to the U.S. market under certain circumstances and restrictions. The panel also recommends, via a 17-13 vote with two abstentions, that Bextra remain on the market. The panel supports Celebrex by a 31-1 vote. Merck says it hasn't decided if it will return Vioxx to the U.S. market, a remark that it has repeated often. Last month, an advisory panel to Canada's health department recommended 12-1 that Vioxx be reinstated. Again, Merck says it hasn't made a decision, adding that it will discuss the matter with health regulators.
April 7, 2005
At the urging of the FDA, Pfizer suspends sales of Bextra. Pfizer disagrees with the FDA's recommendation, and it continues talking to the agency about how the drug can be returned to the market. The FDA also requires tougher labels on Celebrex, all other prescription pain relievers and all over-the-counter pain relievers to warn against cardiovascular risk.
May 5, 2005
Richard T. Clark, a longtime Merck executive, replaces Raymond V. Gilmartin as chief executive. Gilmartin would have reached mandatory retirement age by March 2006.
Aug. 19, 2005
A Texas state court jury votes against Merck in the first Vioxx product liability trial, assessing $253.4 million in economic and punitive damages. Merck says it will appeal.
parts of this timeline source: http://www.thestreet.com/_googlen/stocks/biotech/10239081_3.html