Friday, October 08, 2004

VIOXX, VIOXX AND MORE VIOXX!!! Think just because the FDA allows a drug on the market its safe? WRONG!! BREAKING NEWS: 9-30-04 - VIOXX LINKED TO HEART ATTACK AND STROKE - Click Here for more information regarding the Vioxx recall.  Vioxx Recall FDA News FOR IMMEDIATE RELEASE P04-95 September 30, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product 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. Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of 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 Vioxx 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). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects. Merck contacted 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 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, FDA implemented 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. 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 withdraw Vioxx from the market. Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm. If you or someone you know has been injured as a result of taking the drug VIOXX, you may be entitled to monetary compensation.  Please fill out the form below for a free evaluation of your claim by an experienced attorney.  There is no cost or obligation for this service. For More Vioxx See: www.personal-injury.com www.wrongful-death.com www.vioxx.us.com 5:11:28 PM    comment []

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VIOXX NEWS: VIOXX LINKED TO HEART ATTACK & STROKE Vioxx, a widely used prescription medicine produced by drug manufacturing giant, Merck & Co., was voluntarily withdrawn on September 30, 2004 due to mounting evidence linking it to increased risk of cardiovascular problems. Following a three-year study involving the drug, it was concluded that withdrawing Vioxx from the market would be in the best interest of the patients. The drug, a popular pain reliever used worldwide by millions of patients, has also been connected with higher incidences of respiratory and liver and kidney dysfunction.   Vioxx is classified as a COX-2 inhibitor, a type of drug deemed to be safer for the gastrointestinal system than nonsteroidal anti-inflammatory drugs (NSAIDs). Unfortunately, the cardiovascular safety of this drug family has come under enormous scrutiny of late. Studies have shown that individuals taking Vioxx have between a 17 and 24 percent increase in heart attack risk compared to individuals taking comparable pain relief drugs on the market.[1]   Vioxx is used extensively for the treatment of many types of pain. While most commonly used to treat arthritis-related pain in its various forms, there are a number of other uses for the drug:  Relief of pain and inflammation of osteoarthritis (arthritis from wear and tear on your bones and your joints) Relief of pain and inflammation of rheumatoid arthritis in adults (arthritis caused by a condition where your immune system attacks your joints) Management of short-term pain Treatment of menstrual pain (pain during women’s monthly periods) Treatment of migraine headache attacks with or without aura.[2]      Vioxx has been linked to serious cardiovascular events, including heart attacks and strokes.  If you or someone you love has been injured as a result of taking the drug Vioxx, you may be entitled to monetary compensation. For a free review of your claim, please fill our Vioxx Free Consultation form.  Upon submission, your free consultation form will be sent to the sponsored personal injury lawyer for evaluation. That lawyer will personally evaluate your case, and may contact you to further discuss your situation, and/or attempt to refer you to a qualified lawyer who may be able to assist you.  Please be advised that by submitting a free consultation form, you are not entering into an attorney client relationship with the individual firm or lawyer. 5:04:02 PM    comment []