NEW YORK CITY VIOXX LAYWERS

The New York City Vioxx Lawyers at Kleinick Law represent Vioxx victims in New York City (NYC), Brooklyn, Bronx, Manhattan, and surrounding areas.

On August 25, 2004 a study financed by the FDA found that people taking the recommended dose of Vioxx were at three times the risk of heart attack and sudden death compared to persons taking other non-steroidal pain killers such as ibuprofen. Further those taking Vioxx had a 50% greater chance of sudden cardiac death or heart attack than those using Pfizer's Celebrex, a rival medicine. These results were based on a review of medical records of over 1.4 million people.

On September 29, 2004 MERCK and Co., Inc., announced that it was withdrawing its arthritis drug Vioxx worldwide following indications after a colon cancer trial confirmed longstanding concerns that the drug raises the risk of heart attack and stroke. Merck's decision to withdraw Vioxx from the market came after the Data Safety Monitoring Board overseeing a long-term study of the drug recommended that the study be halted because of dramatic increased risk of serious cardiovascular events, including heart attacks and strokes, amongst studied patients taking Vioxx compared to patients receiving Plasebo. The longer a patient has been taking Vioxx the greater the risk of cardiac complications later.

VIOXX SYMPTOMS

Vioxx symptoms you could experience include:

• Chest Pain or discomfort
• Fatigue
• Dizziness
• High Blood Pressure
• Lightheadedness
• Weakness
• Heart Murmur
• Awareness of Heart Beat
• Palpitations
• Fast Heart Beat
• Angina (Chest Pain)
• Chest Tightness
• Inability to Speak
• Weakness in Arm(s) or Leg(s)
• Inability to Walk

FREQUENTLY ASKED QUESTIONS ABOUT VIOXX

What is Vioxx?

Vioxx is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID). Vioxx is also related to the non-selective NSAID's, such as ibuprofen, Celebrex and Naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.

What should I do if I am currently taking Vioxx?

The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician immediately to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specifics needs.

What are the likely long-term health effects, if any of taking this product?

The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.

What evidence supports the public health advisory?

Merck's decision to withdraw Vioxx from the market is based on new data from a trial called APPROV trial. In the APPROV trial, Vioxx was compared to Placebo (sugar-pill). The purpose of the trial was to see if Vioxx 25mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment of Vioxx compared with Placebo.

Keith Kleinick can give you information about a structured settlement if you are currently receiving compensation payments for a Vioxx case.

Did the FDA require Merck to pull Vioxx from the shelves ?

No, Merck made the decision independent of input from the FDA. The agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.

What action did the FDA take?

FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co Inc. voluntarily withdrawing Vioxx from the market due to safety concerns.

What did FDA know about the risk of heart attack and stroke when it approved Vioxx?

FDA originally approved Vioxx in May 1999. The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that the patients taking Naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trial to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

Will Vioxx be recalled?

FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways.

1. Visit: www.fda.gov/medwatch and click on "How to Report"
2. Call 1-800-FDA-1088

The New York City Vioxx Lawyers at Kleinick Law will use their many years of experience handling drug products liability cases to investigate every possible factor that could cause injury or death. We also ensure that you will receive full compensation for your or your loved one's injuries.