To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FLOXIN Treatment For Pelvic Inflammatory Disease Cleared by FDA URL: http://www.pslgroup.com/dg/EF9E.htm Doctor's Guide December 23, 1996
RARITAN, N.J., Dec. 23, 1996 -- The U.S. Food and Drug Administration has cleared the antibiotic FLOXIN(R) Tablets (ofloxacin tablets) as the first oral medication that can be used alone to treat pelvic inflammatory disease (PID), a condition that afflicts one million women in the U.S. each year. PID can lead to serious complications, including infertility. Previous PID treatment required injections or intravenous medication in combination with oral antibiotics. "PID has historically been difficult to diagnose and treat because it often produces only vague symptoms or no symptoms at all, and women had to undergo a complex treatment regimen in order to cure the infection," said Richard L. Sweet, M.D., chairman of the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh School of Medicine. "This is the first time we'll be able to effectively treat this serious infection without injection or intravenous therapy, which should enable some women to avoid hospital stays." Currently about 200,000 women are hospitalized each year for PID at an average hospital stay of 4.8 days. Current estimates are that $4.2 billion is spent on the treatment of PID and its complications. FLOXIN can now be taken orally twice a day for two weeks to treat PID. The anti-infective has been widely used in the U.S. since 1991 to treat a wide range of genitourinary tract infections, including urinary tract infections, gonorrhea and chlamydial infection. Pelvic inflammatory disease is thought to occur when an infection of the genital tract spreads from the cervix, up into the uterus, fallopian tubes and ovaries. PID can develop from several days to several months after infection with a sexually transmitted disease (STD), most commonly gonorrhea or chlamydial infection. Left untreated, the condition can lead to chronic pelvic pain, abnormal pregnancies and infertility in many instances. PID is one of the most serious complications of sexually transmitted infections among women, leading to nearly a quarter million hospitalizations and more than 100,000 surgical procedures each year. The most common symptom of PID is dull pain or tenderness in the lower abdomen. Other possible symptoms include bleeding between menstrual periods, increased or changed vaginal discharge, pain during intercourse, nausea and/or vomiting, fever, and chills. "The tragedy is that many sexually active women will have no symptoms or symptoms too mild to notice until very late in the progression of PID, and by then the damage has been done -- they may have problems getting pregnant or be unable to have children at all," explained Peggy Clarke, president of the American Social Health Association (ASHA). "Women need to talk with their health care providers about their risk of PID, since early diagnosis and treatment can help preserve their fertility and prevent later complications." In multicenter studies which evaluated the safety and effectiveness of ofloxacin as a monotherapy in the treatment of acute, uncomplicated PID, patients received 400 mg of ofloxacin twice daily for 10 to 14 days. Ninety-eight percent of patients experienced clinical cure, including patients with severe disease. At long-term follow-up, no clinical evidence of relapse or reinfection was noted. Overall, most adverse events were not serious, the most common being nausea, fungal infection and abdominal pain. Please see enclosed package insert for full prescribing information. FLOXIN is marketed by Ortho-McNeil Pharmaceutical, Raritan, N.J., a Johnson & Johnson company. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.