California Vioxx Side Effects Attorneys
West Coast Pharmaceutical Error Lawyers

Masry & Vititoe has been successfully representing seriously injured victims of pharmaceutical errors, medical malpractice, and dangerous drug injuries, as well as the families of wrongful death accident victims for decades. Our experienced California Vioxx Side Effect attorneys have extensive legal and drug error expertise. If you or a loved one has suffered as the result of taking the arthritis drug Vioxx, contact a Vioxx injury lawyer at Masry & Vititoe today.

The following are news stories related to Vioxx and the recall of Vioxx:

Journal Runs Correction on Vioxx

By Denise Gellene, Times Staff Writer
June 27, 2006

The withdrawn painkiller Vioxx could cause heart problems for patients taking it for less than 18 months, according to a correction in the New England Journal of Medicine that disputes the company's contention that the drug was safe when taken for a short time.

The journal said the original statistical analysis of a March 2005 study was incorrect and it was uncertain how long the drug could be safely taken before patients incurred an increased risk of stroke and heart attack.

Click here to read the entire news story.

Click here to read the report from the New England Journal of Medicine.

Cardiologist says Vioxx still a risk after stopping

By Bill Berkrot
Fri May 12, 2006

NEW YORK (Reuters) - A leading cardiologist on Friday disputed Merck & Co's interpretation on the safety of patients once they stop taking Vioxx, saying they remained at high risk of heart attacks or strokes for some time afterward.

Dr Steven Nissen, interim chairman of cardiology at the prestigious Cleveland Clinic, said Merck misrepresented an analysis of data from a follow-up review of patients involved in the trial that led to the pain medication being pulled from the market.

Click here to read the entire news story.

FDA Public Health Advisory - Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)
FDA/Center for Drug Evaluation and Research - December 23, 2004

The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents.

Recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Click here to read the entire advisory.

FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors - Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective Agents
FDA Talk Paper - December 23, 2004

The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.

In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease).

Click here to read the entire paper.

Statement of Sandra Kweder, M.D., Deputy Director, Office of New Drugs at the Center for Drug Evaluation and Research, FDA
before Committee on Finance, United States Senate - November 18, 2004

Modern drugs provide unmistakable and significant health benefits. It is well recognized that FDA's drug review is a gold standard. Indeed, we believe that FDA maintains the highest worldwide standards for drug approval. FDA grants approval to drugs after a sponsor demonstrates that they are safe and effective. Experience has shown that the full magnitude of some potential risks do not always emerge during the mandatory clinical trials conducted before approval to evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events. That is why Congress has supported and FDA has created a strong post-market drug safety program designed to assess adverse events identified after approval for all of the medical products it regulates as a complement to the pre-market safety reviews required for approval of prescription drugs in the United States. Monitoring the drug safety of marketed products requires close collaboration between our clinical reviewers and drug safety staff to evaluate and respond to adverse events identified in ongoing clinical trials or reported to us by physicians and their patients. The most recent actions concerning the drug Vioxx (rofecoxib) illustrates the vital importance of the ongoing assessment of the safety of a product once it is in widespread use.

Click here to read the entire statement.

After Vioxx's withdrawal, patients suffer aftershocks
By Anita Manning - USA TODAY - October 4, 2004

Doctors were bombarded with phone calls from worried patients following the announcement last week that drug manufacturer Merck had pulled its popular arthritis drug, Vioxx, from the market because of safety concerns.

Click here to read the entire story.

Merck Pulls Arthritis Drug Vioxx from Market
All Things Considered - NPR - September 30, 2004

Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck.

To read more, click here.

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product
FOR IMMEDIATE RELEASE - September 30, 2004

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

To read more, click here.

Vioxx (rofecoxib) Questions and Answers
September 30, 2004

1. What action did Merck take today?
   Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).
2. What is Vioxx?
   Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.

To read more, click here.

Vioxx Safety Debate Renewed After FDA Report
By Ed Edelson - HealthDay Reporter - August 27, 2004

FRIDAY, Aug. 27 (HealthDayNews) -- A new study linking high doses of Vioxx to an increased risk of heart attacks and sudden cardiac deaths has re-ignited a running debate about the safety of the arthritis drug.

To read more, click here.

FDA study finds Vioxx increases heart attack risk
Reuters - August 26, 2004

Aug 26 (Reuters) - Patients taking Merck & Co Inc's Vioxx (rofecoxib) arthritis drug had a 50 percent greater chance of heart attacks and sudden cardiac death than individuals using Pfizer Inc's rival Celebrex (celecoxib) medicine, according to a large study financed by the US Food and Drug Administration.

To read more, click here.

FDA Approves New Indication and Label Changes for the Arthritis Drug Vioxx
April 11, 2002

FDA has approved a supplemental application for the use of Vioxx (rofecoxib) for rheumatoid arthritis adding the indication to the previously approved indications for osteoarthritis and pain. FDA has also approved new label text and precautions that are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR).

To read more, click here.

Department of Health and Human Services
2001

Dear Mr. Gilmartin:

This Warning Letter concerns Merck & Co. Inc.'s (Merck) promotional activities and materials for the marketing of Vioxx (rofecoxib) tablets. Specifically, we refer to promotional audio conferences given on behalf of Merck by Peter HoIt, MD, a press release, and oral representations made by Merck sales representatives to promote Vioxx. As part of its routine monitoring and surveillance program the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed your promotional activities and materials and has concluded that they are false, lacking in fair balance, or otherwise misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. See 21 U.S.C. 33 l(a) and (b), 352(a), (f), and (n), and 355 (a).

To read more, click here.

If you or a loved one has suffered serious side effects as the result of Vioxx contact a California Vioxx lawyer today at Masry & Vititoe.