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Vioxx

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.

, Merck made this decision independent of input from 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.

FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.

What action did FDA take regarding Vioxx?

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 are the likely long-term health effects, if any, of taking Vioxx?

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 on Vioxx?

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial.  In the APPROVe trial, Vioxx was compared to placebo (sugar-pill).  The purpose of the trial was to see if Vioxx 25 mg 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 with Vioxx compared with placebo.

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 patients taking Vioxx had fewer stomach ulcers and bleeding than 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 trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

Is FDA’s expedited review process putting riskier drugs on the market? 

No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding.  A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval. 

What other drugs are similar to Vioxx?

Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID).  Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.

The pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages.This is first vioxx lawsuit and thousands are already filed.

If you have concerns about the safety of Vioxx, or if you have experienced serious side effects associated with the drug,it is advisable to consult your doctor inmmediately and go for an alterntive drug. It may also be important to contact an attorney who can help protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

With reference from fda

 

 
     
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