Vioxx was voluntarily recalled on September 30, 2004, by drug giant Merck following information that people taking Vioxx are twice as likely to have heart attacks and strokes as people who take older anti-inflammatory drugs, such as naproxen.
The Vioxx recall culminates mounting concern in the medical community beginning in early 2001, that Vioxx might cause serious cardiovascular events. On April 11, 2002, the FDA required Merck to include new label precautions for cardiovascular risks. Over two years later, Merck is finally removing this unsafe prescription medication from the market.
Vioxx, a member of a new category of drugs called “Cox inhibitors”, has provided pain relief and anti-inflammatory effects for millions of arthritis suffers. It was also indicated for use in acute menstrual pain. It can be said that Vioxx is the progeny of aspirin. The advertised advantage of this new class of drugs over the traditional non-steroidal anti-inflammatory drugs, such as aspirin, ibuprofen and naproxen, is there are supposedly fewer gastrointestinal problems occurring during treatment with Cox inhibitors. However, continuing drug studies reveal GI problems (perforations, ulcerations, and bleeds) as well as serious and potentially deadly, cardiovascular side effects.
The company’s decision to recall the drug is based on new three-year data from a prospective, randomized, placebo-controlled clinical trial conducted at The Cleveland Clinic. The company stopped the trial which was designed to evaluate the efficacy of Vioxx at a new dosage of 25 mg to specifically prevent recurrence of colorectal polyps in patients with a history of colorectal adenomas. In other words, Vioxx was being tested for a new indication other than arthritis and menstrual pain.
During the study, it was proven that the Cox inhibitor process throws off the body’s normal chemical balance and blood clots may develop. These blood clots form in the coronary arteries or in the brain and heart attacks or strokes result.
Vioxx was much hailed as a wonder drug for those with painful arthritis symptoms when it was launched on the market in the United States following FDA approval on May 21, 1999. It has since been marketed in more than 80 countries; worldwide sales of Vioxx in 2003 alone were $2.5 billion. Vioxx can clearly be classified as a blockbuster drug.
Patients who are currently taking Vioxx should contact their physician to discuss alternative treatments. Patients may obtain additional information regarding the recall at www.merck.com or by calling 1-888-368-4699.
If you or someone you know, has been injured by taking Vioxx, you may be entitled to compensation. If you would like to explore your legal rights, please provide the following information and e-mail it to firstname.lastname@example.org (Jon L. Gelman) or call toll free at 1-888-696-7900
State of Residence:
Best Time to Call:
Please provide the following information to allow us to better serve you:
1. Approximate dates of Vioxx use: From To
2. What dosage did you take per day:
3. Was the dosage ever changed? To what?
4. When were you first aware of any medical problems related to Vioxx?
5. Did you experience any of the following conditions related to Vioxx?
__Deep Vein Thrombosis
__Other condition: (Please explain)
6. Did your physician provide that your diagnosis could be related to Vioxx?
E-mail this form to email@example.com or go to our online submit form http://www.gelmans.com/FrontEnd/Cases/submit_case.asp
More information about the Vioxx recall
[September 30, 2004 Public Health Advisory - FDA]
FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product
Vioxx (rofecoxib) Questions and Answers