What You Need to Know About Vioxx From Medical Journal Publications

Medical journals and publications have studied the side effects of Vioxx, Aspirin and Vioxx, Arthrotec, Vioxx with Asthma and other important topics. The medical journal abstracts below can help you understand the serious issues. If you need further help, please fill out this simple form, call our client relations department at 1 (800) 476-6070, or email us at clientrelations@weitzlux.com.

March-April 2004

“Acute Congestive Heart Failure Induced by Rofecoxib.” JABFP

By Robert J. Campbell, MD, and Kevin B. Sneed, PharmD

Although NSAIDs are prescribed for the treatment of inflammatory conditions as well as for chronic pains, they have the potential to cause harmful side effects. A case is mentioned involving a 42-year-old woman who suffered from acute congestive heart failure secondary to Rofecoxib. Prior to taking Rofecoxib, the patient suffered no symptoms of congestive heart failure. Once she stopped taking Rofecoxib, she was quick to recover from all symptoms associated with congestive heart failure. It has been decided, based on clinical discussion and review of literature that the cause of acute congestive heart failure is most likely caused by increasing the dosage of Rofecoxib to 50 mg after previously being treated with a dosage of 25 mg.

7 October 2004

“Coxib Cardio Risks: Case Effect?.” EU health regulators reviewing long-term data for all Cox-2 inhibitors; U.S. researchers cite evidence for class risk, blast inaction on rofecoxib.

By Ed Lamb, Pharmacy Today

Due to the worldwide withdrawal of Rofecoxib, administered by Merck, the European Medicines Agency (EMEA) will review the long term data on cardiovascular safety for all licensed Cox-2 inhibitors. Pfizer, the makers of Celebrex and Bextra (also Cox-2 agents), is denying that any of there drugs contain similar risks as Rofecoxib. However, Garrett A. Fitzgerald, MD, of the University of Pennsylvania claims in an article posted to the NEJM that all coxibs have the same risks for adverse cardiovascular events. Fitzgerald notes in a soon-to-be published article that all Cox-2 inhibitors raise the risk of developing MI and thrombotic strokes. Eric J. Topol, MD, of the Cleveland Clinic Foundation also wrote an article titled “Failing the Public Health—Rofecoxib, Merck, and the FDA.” In his article, Topol discusses the need for a congressional investigation of Merck and the FDA.

5 February 2004

“Relationship Between Selective Cyclooxygenase-2 Inhibitors and Acute Myocardial Infarction in Older Adults.”

By Daniel H. Solomon, MD, MPH; Sebastian Schneeweiss, MD, ScD; Robert J. Glynn, PHD, ScD; Yuka Kiyoya, MD, MPH; Raisa Levin, mSc; Helen Mogun, MSc; Jerry Avorn, MD.

A study is being conducted to test whether Cox-2 inhibitors, which originally were developed to decrease the amount of gastrointestinal problems that is caused by nonselective NSAIDs, actually increases the risk of cardiovascular conditions. Users of Celecoxib (celebrex), Rofecoxib (Vioxx), and NSAIDs were tested to see whether there was a risk of developing acute myocardial infarction (AMI). The study included 54,475 patients over the age of 65. It concluded that Rofecoxib linked to greater risks of AMI compared with Celecoxib. The higher risk of AMI caused by Rofecoxib was much greater when a patient was taking dosages of 25 mg or more.

24 February 2003

“Effect of Selective Cyclooxygenase 2 Inhibitors and Naproxen on Short-term Risk of Acute Myocardial Infarction in the Elderly.”

By Muhammad Mamdani, PharmD, MA, MPH; Paula Rochon, MD, MPH; David N. Juurlink, MD; Geoffrey M. Anderson, MD, PhD, Alex Kopp, BA; Gary Naglie, MD; Peter C. Austin, PhD; Andreas Laupacis, MD, MSc

A population-based retrospective cohort study was conducted comparing the rates of Acute Myocardial Infarction (AMI) among elderly patients given selective Cox-2 inhibitors, naproxen, and nonselective NSAIDs. There was no increase in short term risk of AMI among users of selective Cox-2 inhibitors. Additionally, there was no conclusion that found a short-term reduced risk of AMI with naproxen.

September 2002

“Do Cyclooxygenase Inhibitors Increase Risk of Cardiovascular Thrombotic Events?’

By Brent Kvern, MD, CCFP, FCFP

Dr. Brent Kvern, MD commented on an article written by Steven D Mukherjee and EJ Topol titled “Risk of Cardiovascular Events Associated with Selective Cox-2 Inhibitors.” This was a systematic review and descriptive subgroup analysis. The question presented asks whether patients who take Cox inhibitors suffer from more cardiovascular events than patients who do not. Kvern cautions the readers by saying that more trials need to be administered to determine the degree of risk associated with COX inhibitors. Although COX inhibitors lead to a reduced risk of GI side effects, there is an increased rate of thrombosis.

5 May 2004

“Rofecoxib, a COX-2 Inhibitor , Lowers C-Reactive Protein and Interleukin-6 Levels in Patients with Acute Coronary Syndromes.”

By Daniel Monakier, MD; Michael Mates, MD; Marc W. Klutstein, MD; Jonathan a. Balkin, MBBS; Bernard Rudensky, MD; David Meerkin, MBBS; and Dan Tzivoni, MD.

Patients suffering from acute coronary syndromes (ACS) have high levels of inflammatory mediators such as C-reactive protein (CRP) and interleukin (IL)-6. The aim of the study was to determine whether patients taking Rofecoxib to treat ACS will have reduced CRP, IL-6, and soluble tumor necrotic factor receptor-1 (sTNF-R1) levels and greater endothelial function with aspirin. For a period of three months, 34 patients who were hospitalized with ACS were administered 25 mg of rofecoxib plus aspirin or a placebo plus aspirin. There was a decrease in the CRP level among the rofecoxib group that took aspirin. However, a large scale study will be needed for follow-up of these results.

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