OWH eUpdate 

www.fda.gov/womens Winter 2008 

In This Issue Message from the Director • OWH Research 

The FDA Office of Women’s Health is pleased to bring you the first 

eUpdate of 2008. This year the recurring theme for the eUpdate and 

for the Office as a whole will be “safety”. In this issue, you will find 

information on recent FDA actions related to the safe use of 

contraceptive products, as well as links to the new OWH birth control 

guide for consumers. This update also highlights information on 

outreach partnerships to promote safe medication use and OWH 

research projects on clinical trials safety data. OWH strives to 

provide our partners with greater access to the latest scientific, 

regulatory, and consumer safety information from the Agency. 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Heart Health 

Free Publications 

Spanish Fact Sheets 

Birth Control Kathleen Uhl, MD 

e-Update Archive Assistant Commissioner for Women’s Health 

 

FDA Highlights 

Cold Medicines & Kids OWH Research 

Info on use of cough & cold 

meds by kids under age 2 

Report a Problem Tracking Women In Clinical Trials Report problems with 

medical products, 

cosmetics, food, etc. In 2007, OWH conducted several projects related to the participation 

of women in clinical trials. OWH completed a pilot project that 

created a standardized review template to capture demographic data 

from clinical drug reviews. The aim of this project was to provide a 

consistent data format that would improve the ability to track safety 

and efficacy information for women and other demographic 

subgroups. In addition, OWH recently completed projects that 

addressed the planning of subgroup analysis specifically for sex 

differences, contraception requirements for women enrolling in 

clinical trials, and the enrollment of women and minorities in clinical 

trials for diabetes drugs. A list of projects funded by OWH and 

conducted by OWH staff can be found on our updated Women in 

Clinical Trials webpage, http://www.fda.gov/womens/trials.html. 

FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

Chantix Advisory 

New safety warnings 

 

Wrinkle Fillers 

Info for consumers 

Contact Us 

5600 Fishers Lane 

Room 16-65 

Rockville, MD 20857 

301-827-0350 (phone) 

301-827-0926 (fax)

owh@fda.gov
Outreach Initiatives 

New Birth Control Information Available 

OWH has developed a new Birth Control booklet and poster. The 

booklet features illustrations of the 18 contraceptive products 

currently approved by the FDA and on the market, along with risk 

and effectiveness data. It also includes a handy tear-out chart for 

comparing all the products at a glance. 

To View and Download the Birth Control booklet, visit: 

http://www.fda.gov/womens/healthinformation/birthcontrolguide.pdf

To Order Bulk Copies from the Federal Clearinghouse, go to: 

http://www.pueblo.gsa.gov/results.tpl?id1=16&startat=1&--

woSECTIONSdatarq=16&--SECTIONSword=ww

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Pharmacy Choice Web Portal Features OWH Publications 

Pharmacy Choice, Inc. and the FDA OWH are collaborating to make 

it easier for pharmacists, pharmacy technicians, and students to 

keep up with the latest consumer health information from the FDA. 

Pharmacy Choice has created a special web portal just for OWH 

consumer health education materials. The portal will provide easy 

access to all OWH fact sheets and medication guides. 

Pharmacy Choice web portals provide a comprehensive suite of webbased tools and information, including drug information, industry 

news, and education programs. OWH and Pharmacy Choice, Inc. 

invite you to collaborate in distributing the information to women 

and their families across the country. 

Check out the new website at: 

http://www.pharmacychoice.com/resources/fda/index.cfm

Hot Topics 

FDA Takes Action on “Bio-Identical” Hormone Products 

FDA issued several warning letters notifying certain compounding 

pharmacies about unlawful practices related to their so-called "bioidentical hormone replacement therapy" (“BHRT”) drugs, a form of 

menopausal hormone therapy. FDA’s letters warned the pharmacies 

that the claims they make about the safety and effectiveness of their 
"BHRT" products are unsupported by medical evidence, and are 

considered false and misleading by the agency. These false claims 

include statements that compounded “BHRT” drugs are safer or 

more effective than FDA approved hormone therapy drugs and 

claims that compounded “BHRT” drugs can prevent or treat serious 

illnesses such as Alzheimer’s disease and certain forms of cancer. 

In addition, FDA warned a number of pharmacies that they may not 

compound products using the hormone estriol, without a valid 

investigational new drug application. No drug product containing 

estriol has ever been approved by FDA and the safety and 

effectiveness of estriol are unknown. 

FDA's action will not limit women's access to compounded hormone 

therapies prescribed by her physician to meet her specific medical 

needs. However, because compounded drugs are not reviewed by 

the FDA for safety and effectiveness, FDA encourages patients to 

use FDA-approved drugs whenever possible. All patients who use 

compounded hormone therapy drugs should discuss the various 

options for menopausal hormone therapy with their health care 

provider. 

The warning letters and additional information can be viewed at: 

http://www.fda.gov/cder/pharmcomp/default.htm

A consumer article called “Bio-Identicals: Sorting Myths from Facts” 

can be viewed at: 

http://www.fda.gov/consumer/updates/bioidenticals010908.html

OWH Menopause Publications for Consumers: 

http://www.fda.gov/womens/pubs.html

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Label Changes for Birth Control Patch 

The FDA approved additional changes to the label for the Ortho Evra 

Contraceptive Transdermal (Skin) Patch. The new label includes the 

results of a new epidemiology study that found that women who 

used the birth control patch were at higher risk of developing serious 

blood clots, also known as venous thromboembolism (VTE), than 

women using birth control pills. 

Ortho Evra is a prescription patch that releases hormones through 

the skin into the blood stream. Because the hormones are processed 

by the body differently than hormones from birth control pills, 

women using the patch can be exposed to about 60 percent more 

estrogen than if they were using typical birth control pills. Increased 

levels of estrogen may increase the risk of side effects, including 

serious blood clots. 
For more information of Ortho Evra, visit: 

http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm

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New Warning for Products Containing Nonoxynol 9 (N9) 

On December 18, 2007, FDA issued a final rule that requires new 

warning statements and other information on the labels of over-thecounter (OTC) stand-alone vaginal contraceptive and spermicidal 

products containing nonoxynol 9 (N9). 

The new labels must include a warning that N9 does not provide 

protection against infection from HIV (the virus that causes AIDS) or 

other sexually transmitted diseases (STDs). 

In addition, FDA is requiring that the labels warn consumers that N9 

in stand-alone vaginal contraceptives and spermicides can irritate 

the vagina and rectum, which may increase the risk of contracting 

HIV/AIDS from an infected partner. 

Stand-alone spermicides include gels, foams, films, or inserts that 

are used by themselves for contraception. 

The new warnings can be viewed at: 

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01758.html

The full text of the final rule is posted at: 

http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6111.htm

Update Extras 

Conferences 

The OWH Outreach Team is busy exhibiting at conferences across 

the country to increase awareness and dissemination of the over 50 

OWH health education fact sheets and brochures available for 

consumers. 

Visit the OWH exhibit booth at these upcoming conferences: 

Sister-2-Sister Women’s Heart Day, February 1 – Washington, DC 

Natl. Conf. on African Americans and AIDS, February 25-26 – Philadelphia 

Anxiety Disorders Association of America, March 6-9 – Savannah, GA 

American Pharmacists Association, March 14-17 – San Diego, CA 

NCOA-ASA Aging in America Conference, March 27-29 – Washington, DC 

Women’s Health 2008, March 28-30 – Williamsburg, VA 
*************************** 

Presentations 

Conference: National Birth Defects Prevention Network Annual Meeting

Poster: Medical Product Exposure during Pregnancy: An Update on 

 the OWH Pregnancy Exposure Registry Website 

Authors: Pellavi Sharma, Ameeta Parekh, Elizabeth Duvall-Miller, 

 Connie O’Leary, Kathleen Uhl 

Date: February 11-13, 2008 

Location: Washington, DC 

Conference: Uniformed Services Academy of Family Physicians

Presentation: FDA & Drug Development

Speaker: Kathleen Uhl 

Date: March 16, 2008 

Location: Portland, OR

Conference: Uniformed Services Academy of Family Physicians

Presentation: FDA & Drug Use by Pregnant & Lactating Women

Speaker: Kathleen Uhl 

Date: March 18, 2008 

Location: Portland, OR

Conference: Society for Gynecologic Investigation

Presentation: "Women's Health on Critical Path'

Speaker: Ameeta Parekh

Date: March 26-29, 2008 

Location: San Diego, CA 

Conference: American Society for Clinical Pharmacology & Therapeutics

Presentation: Women's Health: At the Intersection of Science, Policy 

 & Politics

Speaker: Kathleen Uhl

Date: April 3, 2008 

Location: Orlando, FL

Publications 

Title: Outpatient Use of cardiovascular drugs during pregnancy 

Journal: Pharmacoepidemiology and Drug Safety. 2008 Jan 16 

Authors: Andrade SE, Raebel MA, Brown J, Lane K, Livingston J, 

 Boudreau D, Rolnick SJ, Roblin D, Smith DH, Dal Pan GJ, 

 Scott PE, Platt R 

PubMed ID: 18200619

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