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Vioxx
I AM GLAD THAT WE HAVE A PLACE LIKE CANADA DRUGS .IT HELPS WITH SOME OF MY DRUGS ,THAT I CAN NOT AFFORD AT WAL-MART  W. corkern plainfield, 
Pharmacist Notes
 Please visit the manufacturer's website for more information about the voluntary recall of this product. http://www.merck.com/ Merck is offering patients a full refund for the amount they paid out-of-pocket for VIOXX prescriptions that remained unused as of September 30, 2004. Patients seeking a refund for unused VIOXX should contact the National Notification Center (NNC) at 1-800-805-9542.  (rofecoxib) PLEASE NOTE: * All prices are subject to change at any time. . For questions regarding pricing and availability of products from CanadaDrugs.comTM you may call 1-800-226-3784.  FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Producthttp://www.fda.gov/bbs/topics/news/2004/NEW01122.html 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. 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. #### The following monograph is provided by Thomson Healthcare and may be related to the prescription drugs listed above. Drug monograph for the active ingredient in VioxxThe following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you. ROFECOXIB (Systemic)*†Some commonly used brand names are: In the U.S.—
*† Not commercially available in the U.S. and Canada. Category
DescriptionRofecoxib (roe-fe-COKS-ib) is used to relieve some symptoms caused by arthritis, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it. Rofecoxib is also used to relieve other kinds of pain, such as menstrual cramps, and pain following surgery. This medicine was available in the following dosage form(s):
Before Using This MedicineIn deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rofecoxib, the following should be considered: Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to rofecoxib. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy—Rofecoxib has not been studied in pregnant women. However, there is a chance that this medicine may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy. Studies in animals have shown that rofecoxib has caused birth defects of the spine. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Breast-feeding—It is not known whether rofecoxib passes into breast milk. However, rofecoxib may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor. Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of rofecoxib in children with use in older age groups. Older adults—This medicine has been tested in a limited number of elderly patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults. Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rofecoxib, it is especially important that your health care professional know if you are taking any of the following:
Other medical problems—The presence of other medical problems may affect the use of rofecoxib. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This MedicineFor safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects. Storage—To store this medicine:
Precautions While Using This MedicineIf you will be taking this medicine for a long time, your doctor should check your progress at regular visits. Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor . Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while taking this medicine, unless your doctor has directed you to do so and is following your progress . Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs often occur, including severe stomach pain, black tarry stools, and/or vomiting of blood or material that looks like coffee grounds; skin rash; swelling of the face, fingers, feet, and/or lower legs. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs . Rofecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention . The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives. Side Effects of This MedicineAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur: More common Congestion in chest; cough; fever; sneezing; sore throat Less common or rare Bloody or black, tarry stools; chills; burning feeling in chest or stomach; hives; loss of appetite; muscle aches and pain; prolonged or severe vomiting; shortness of breath; skin rash; tenderness in the stomach area; unusual weight gain; vomiting of blood or material that looks like coffee grounds Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome: More common Back pain; diarrhea; dizziness; headache; heartburn; loss of energy or weakness; nausea; stuffy or runny nose; swelling of legs and feet Less common or rare Blurred vision; constipation Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
Developed: 06/14/1999 The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare makes no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products. Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 
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