Welcome to our summer edition of the FDA Office of Women's Health Update. This quarterly summary highlights the activities of our outreach and science programs. Read on for the latest information about regulatory actions and upcoming meetings of interest to women's health. All issues of this publication are available online in the OWH Update Archive.
Our collective efforts are being recognized by the American Pharmaceutical Association (APhA) Foundation and Health Care Quality Alliance (HCQA). APhA and HCQA recently announced that the Women's Health: Take Time To Care campaign was selected to receive one of three annual Pinnacle Awards. This prestigious award recognizes pioneering individuals and groups for their contributions and exemplary leadership in medication use quality improvement. The TTTC program has accomplished this with its "Use Medicines Wisely" consumer literature and media campaign, promotion of local, interactive educational sessions led by pharmacists and other health practitioners, and its partnering with more than 80 non-profit and corporate supporters, including thousands of chain drug stores across the country.
The Health Care Quality Alliance brings together 97 national health care consumer, provider, state/national legislative and industry organizations dedicated to assuring that quality is the core value of the nation's health care agenda. The Pinnacle Award will be presented at a dinner ceremony at the Canadian Embassy, in Washington, DC, June 14, 2000.
The OWH Scientific Research Program funds research projects aimed at improving the agency's policies and decisions on women's health issues. The program utilizes a competitive peer review process for selection of the highest quality projects, with an emphasis on projects that significantly contribute to the scientific basis of FDA's regulatory actions in women's health.
For fiscal year 2000, OWH funded the following research projects in women's health:
The Office of Women's Health, in collaboration with the Office of Regulatory Affairs, is pleased to announce the funding of twelve outreach projects. These projects are designed to address women's health issues identified by FDA public affairs staff across the country. The projects reach across the country and include workshops that will address the Surgeon General's Health Disparities and inform women about FDA's responsibilities, including mammography quality standards, medication risks and nutrition. Highlights include the development of a Women's Health Care Trainer's Kit and Medication Use Guide for non-English speakers by the Los Angeles Field Office. In addition, a "tri-city" mammography screening awareness program will be conducted in Houston, Dallas and Atlanta.
New Drug Approved for Irritable Bowel Syndrome
Women with irritable bowel syndrome (IBS) whose primary symptom is diarrhea now have another option for treating their condition. Alosetron hydrochloride (Lotronex) was approved in February to treat IBS symptoms such as chronic or recurrent abdominal pain, diarrhea and constipation, and the sudden, urgent need to go to the bathroom. IBS is a functional abnormality of the gastrointestinal tract that is estimated to affect up to 15% of the Americans - women three times more men. The most frequent adverse event reported by study participants taking alosetron was constipation. In addition, four study patients taking alosetron developed acute colitis, a potentially serious inflammation of the large intestine. This condition resolved without serious consequences when the drug was discontinued. Further assessment is underway as part of a Phase IV commitment by the sponsor to conduct a population risk trial to assess the incidence of colitis in patients receiving alosetron.
Health care providers are advised to interrupt treatment immediately and to evaluate promptly patients who have symptoms of acute colitis such as bloody diarrhea and sudden, significant worsening of abdominal pain. The FDA encourages health care providers to report any such cases to FDA's MedWatch program by calling 1-888-INFO-FDA or by logging onto FDA's web page, www.fda.gov/medwatch/. Alosetron was not approved for and is not recommended for men.
On June 27, 2000, the FDA Gastrointestinal Drugs Advisory committee will discuss risk management for this drug based on new cases of colitis that have resulted in hospitalizations and surgeries.
Mifepristone Moves A Step Closer to Approval
FDA issued an approvable letter for a drug regimen that is being evaluated for termination of early pregnancy. FDA sent the letter in February to the Population Council, an international nonprofit research institute, for the drug mifepristone used in combination with misoprostol. Mifepristone is better known as the drug RU-486. FDA issues approvable letters to manufacturers when questions remain to be resolved before final marketing approval can be granted. FDA had issued a letter for mifepristone to the Population Council in September 1996, indicating that the agency believed the drug to be safe and effective, but that unresolved issues remained, including questions about manufacturing. The organization has filed a response to the outstanding issues.
Approval for Continued Marketing of Saline-filled breast implants
The agency determined that saline-filled breast implants made by McGhan Medical Corp. and Mentor Corp., used for breast augmentation in women 18 years or older and breast reconstruction, may remain on the market, despite relatively high complication and failure rates, and information on the risks should be made available to women so they can make informed decisions.
This action was taken as a result of the review of marketing applications submitted by these two companies. The patient labeling can be found on FDA's website at www.fda.gov/cdrh/breastimplants/. In addition the package insert that accompanies the products and patient informed decision brochures will enable women to make a fully informed decision. FDA's decision on these two saline-filled breast implants does not affect silicone gel-filled breast implants, which currently cannot be commercially marketed.
Dietary Supplement Claims and Pregnancy
FDA recently advised dietary supplement manufacturers not to make any claims related to pregnancy on their products based on the agency's structure/function rule. To ensure that careful consideration is given to concerns raised regarding how the structure/function rule relates to pregnancy, FDA held a public meeting in April. The meeting discussed the potential pregnancy related safety concerns, and the need to issue further guidance. FDA urges all pregnant women to consult their health care provider before taking any dietary supplements or medication.
Advisory for Consumers about Fresh Produce
Consumers should buy produce that is not bruised or damaged, and that is refrigerated or stored on ice. After purchase, store produce in the refrigerator promptly, and wash hands often while handling fresh produce. These are just a few of the suggestions following a report by The Centers for Disease Control and Prevention that the incidence of foodborne disease increases during the summer for all food, and includes fresh produce. FDA is also advising consumers to use safe handling and preparation practices for fresh fruits and vegetables. For a listing of practical tips go to: www.fda.gov/bbs/topics/ANSWERS/ANS01017.html
Product Withdrawals
FDA wishes to inform physicians of the removal from the market of troglitazone (Rezulin, Parke-Davis/Warner-Lambert Co, Morris Plains, NJ), a treatment for type 2 diabetes mellitus. Troglitazone has been associated with rare but severe liver toxicity since 1997, and close monitoring of liver function of patients using the drug was recommended. When two other drugs showed the same benefits to patients as troglitazone, apparently without the same level of toxicity, the FDA asked that troglitazone be removed from the market.
Cisapride (Propulsid, Janssen Pharmaceutica Inc, Titusville, NJ), is a treatment for severe heartburn. The drug has been associated with at least 341 reports of heart rhythm abnormalities, including 80 deaths. Most of these events occurred in patients who were taking other medications or who had underlying conditions known to increase the risk of cardiac arrhythmia. Therefore, the company will voluntarily stop marketing cisapride in the United States as of July 14, 2000. The company will continue to make the drug available to patients who meet specific eligibility criteria for a limited-access protocol.
Draft Guidance--Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment
This guidance is intended to provide recommendations for sponsors on the design of clinical trials in support of new drug applications (NDAs) for the treatment of female sexual dysfunction (FSD):
www.fda.gov/cder/guidance/3312dft.htm#P85_2403
The results of an OWH co-funded study on the rupture of silicone gel-filled breast was presented at the Six World Biomaterials Congress on May 18, 2000. The study showed that 69% of the 344 women receiving magnetic resonance imaging (MRI) had at least one rupture breast implant. Of the women undergoing MRI, 21% had silicone gel outside the fibrous capsule that forms around the implant. These results indicate that the rupture of silicone gel implants is much higher than previously believed. For more information on this study, visit FDA's web site at:
www.fda.gov/cdrh/breastimplants/studies/biinterview.html
1. Over-The-Counter Products
Date/Time/Location: June 28 and 29, 8:30 a.m.
Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD 20879.
CONTACT: Patricia L. DeSantis
Center for Drug Evaluation and Research
301-594-5400.
The purpose of the hearing is to solicit information, and the views of, interested persons, including scientists, professional groups, and consumers.
2. CDER LIVE! "CDER and Industry's Role in Minimizing the Pharmaceutical Contribution to Medical Errors"
Date/Time: June 22, 2000 1:00 p.m. to 3:30 p.m.
EDT Registration form and fax to 215-641-1229
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