This article is part of the Arthritis Archives.
Editor note: On 09/30/2004, Merck the maker of Vioxx, issued a worldwide recall, halting sales of the drug. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs Fallout from the Vioxx recall will continue for years to come.
Dateline: May 27, 1999
FDA Approves Vioxx
Vioxx (rofecoxib), which is manufactured by Merck & Co., has been approved by the United States Food and Drug Administration for relief of the signs and symptoms of osteoarthritis, the management of acute pain in adults, and treatment of menstrual pain.
The approval of Vioxx now puts Merck in direct competition with Monsanto, the maker of Celebrex (celecoxib). Both Vioxx and Celebrex belong to the new class of drugs known as COX-2 selective inhibitors.
Merck expects to assume an advantage over Monsanto since Vioxx is said to be "a true once-a-day drug". Monsanto's Celebrex is taken either once or twice a day for osteoarthritis, and twice a day for rheumatoid arthritis. Also, Celebrex is not approved for treatment of acute pain or menstrual pain as is Vioxx and that too may offer a marketing advantage to Merck.
Clinical Trials
Placebo- and active-controlled clinical trials ranging from 6 to 86 weeks and involving about 3900 participants assessed the value of Vioxx in treating the signs and symptoms of osteoarthritis. Trial results indicated that Vioxx (12.5 mg. and 25 mg. once a day) was comparable to ibuprofen (800 mg. three times a day) and diclofenac (50 mg. three times a day) for relief from signs and symptoms of osteoarthritis. In all clinical studies Vioxx was associated with significant reduction in morning joint stiffness.
In two studies of osteoarthritis patients used to assess the incidence of gastrointestinal ulcers among users of Vioxx (25 mg. or 50 mg. daily) versus users of ibuprofen (2400 mg. daily), a significantly lower percentage of ulcers correlated with the Vioxx use. Although uncommon, clinically significant upper gastrointestinal bleeding has occurred in patients receiving Vioxx during controlled trials. Even though the potential for ulcers is low among users of Vioxx, ulcers can still occur without warning and therefore patients and physicians are being warned to be aware of signs of gastrointestinal bleeding.
Common Side Effects
Upper respiratory infection, diarrhea, and nausea were among the most commonly reported side effects during clinical trials of Vioxx. People with allergies to aspirin or other NSAIDs should avoid Vioxx as should women in late pregnancy. The use of Vioxx in children has not been evaluated.
Dosage
The recommended dose of Vioxx for treatment of osteoarthritis is 12.5 mg. once daily. Some patients may receive additional benefit by increasing the dose to 25 mg. once daily. The expected cost of Vioxx is between $2.38 and $2.52 per tablet. Its competitor Celebrex is priced at $2.42 per tablet. Vioxx is expected in pharmacies before mid-June.
Related Resources
Sources: FDA Approves Vioxx For Osteoarthritis Pain And Menstrual Pain, MedWatch, 5/21/99; FDA Approves Osteoarthritis Drug, Intelihealth, 5/24/99; FDA Approves Vioxx For Osteoarthritis, Acute Pain In Adults And Menstrual Pain, P/S/L Group Doctor's Guide, 5/21/99
First published: 05/27/1999
