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| |  Osteoarthritis Drug, Vioxx, Relieves Menstrual Pain WEST POINT, PA. -- October 19, 1999 -- Vioxx® (rofecoxib), a new prescription medicine commonly used for osteoarthritis, also relieves the pain associated with menstrual cramps, the most common gynecological problem among menstruating women, researchers report in this month’s issue of Obstetrics and Gynecology. In the paper by Dr. Briggs Morrison, of Merck Research Laboratories, and his colleagues, the authors write that Vioxx relieved menstrual pain as effectively as the most commonly used prescription treatment for that condition, naproxen sodium, and better than placebo. On May 21, 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx for relief of the signs and symptoms of osteoarthritis (OA), management of acute pain in adults, and treatment of menstrual pain (primary dysmenorrhea). Vioxx is the only non-steroidal anti-inflammatory drug (NSAID) that specifically inhibits the COX-2 enzyme that has been approved for the treatment of menstrual pain. People who have had an allergic reaction to Vioxx, aspirin or other NSAIDs should not take Vioxx. Safety and effectiveness in children below the age of 18 have not been studied.
Most Women With Menstrual Pain Remain Undiagnosed, Under-Treated Women with menstrual pain experience painful cramping in the lower abdomen just before or during their period. Other symptoms include nausea, fatigue, diarrhea, fever, headache and lightheadedness. As many as 90 percent of menstruating women suffer from some degree of menstrual pain, but many women do not discuss menstrual pain with their health care providers. Even women who treat their pain with over-the-counter medicines often don’t take the right dose. The impact of untreated menstrual pain extends beyond the pain itself. One study showed that 42 percent of women missed work or another activity at least once because of menstrual pain, and another study showed that menstrual pain causes 600 million lost work hours and costs $2 billion in productivity each year. "Menstrual pain is a serious problem for a lot of women," says Gail Kincaide, executive director of the National Association of Women’s Health, Obstetric and Neonatal Nurses, "but menstrual pain has to be diagnosed. Health care providers need to be proactive and ask women about lower abdomen pain, and women need to be encouraged to talk about their pain."
Vioxx Relieved Menstrual Pain As Well As Naproxen Sodium The study published today evaluated the effectiveness and safety of Vioxx 50 mg once-daily compared to a prescription-strength dose of naproxen sodium 550 mg every 12 hours and to placebo. One hundred and twenty-seven (127) women aged 18 or older with histories of moderate to severe menstrual pain and no evidence of other causes of menstrual pain participated in the study. Patients treated a series of four menstrual cycles. The women received Vioxx, naproxen sodium or placebo for up to three days, as needed, for each cycle. The study was double-blind and randomized, and each patient took each of the study drugs once at different times during the study. Women who took Vioxx 50 mg reported pain relief lasted for eight hours after taking the medicine, which was the primary endpoint of the study. Women also reported that the pain relief provided by Vioxx 50 mg lasted through 12 hours, the last time pain relief was evaluated for each cycle; efficacy through 24 hours was not evaluated. With Vioxx 50 mg, pain relief at eight hours and 12 hours was generally similar to naproxen sodium and superior to placebo. The recommended starting dose of Vioxx for the treatment of menstrual pain is 50 mg once-daily. Subsequent doses should be 50 mg once-daily as needed. Vioxx and naproxen sodium were well tolerated. The most commonly reported side effects in this study, occurring at a similar rate across all groups including placebo, were nausea, upper-respiratory infection and dry mouth.
Important Information About Vioxx Commonly reported side effects in clinical trials of patients with osteoarthritis were upper-respiratory infection, diarrhea, nausea and high blood pressure. Serious stomach problems, such as bleeding, can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding.
Researchers Say That In Menstrual Pain, Prostaglandins Are Often The Culprits Substances called prostaglandins are at least partly responsible for menstrual pain, the authors write. Women with menstrual pain have higher levels of prostaglandins in the lining of the uterine wall, called the endometrium, and in menstrual fluid, than women who do not experience menstrual pain. In fact, the level of prostaglandins in the endometrium and menstrual fluid is related to the level of pain. These prostaglandins are produced in the body by two forms of the enzyme called cyclooxygenase: COX-1 and COX-2. COX-2 triggers pain and inflammation and COX-1 helps maintain the normal stomach lining. At recommended doses, scientists believe that Vioxx blocks COX-2 while sparing COX-1, while NSAIDs like naproxen sodium inhibit both COX-1 and COX-2. This study was the first to show that COX-2 plays an important role in menstrual pain, the authors write. Since its approval by the FDA in May, more than 2.2 million prescriptions have been written for Vioxx in the United States, making it one of the most successful product introductions in the pharmaceutical industry’s history.
Related Link: Merck & Co., Inc.
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