Vioxx Lawyer - Recall Information:

The Food and Drug Administration (FDA) today (September 30, 2004) acknowledged the voluntary Vioxx recall (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 regarding the Vioxx recall, side effects, and alternative medications.

Merck initiated a recall from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because reported side effects showed an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

FDA approved the drug in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen).

Merck contacted the FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to the FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, the FDA implemented Vioxx warning labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. The FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to recall Vioxx from the market.

More News

• Serious stomach problems, such as stomach and intestinal bleeding, can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs that you may have this serious side effect and tell your doctor right away.
  
• Serious allergic reactions including swelling of face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing occur rarely but may require treatment right away.
  
• Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure.
  
• Severe liver problems occur rarely in patients taking NSAIDs. Tell your doctor if you develop symptoms of liver problems. These include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms.

• Upper and/or lower respiratory infection and/or inflammation
• Headache
• Dizziness
• Diarrhea
• Nausea and/or vomiting
• Heartburn, stomach pain and upset
• Swelling of the legs and /or feet
• High blood pressure
• Back pain
• Tiredness
• Urinary tract infection.