NEW SURVEY SUGGESTS OVERLOOKED SIDE EFFECT CAUSES MANY WOMEN TO STOP OR SWITCH BIRTH CONTROL PILLS

Breakthrough Bleeding Between Periods Impacts Pill Use

Raritan, NJ (BlackNews.com) - Many women consider weight gain to be the top reason women stop or change their birth control pills, yet a survey(1) released today by Ortho Women's Health, a unit of Ortho-McNeil Pharmaceutical Inc., suggests breakthrough bleeding (defined as the bleeding that a woman on the Pill experiences at an unexpected time) is a culprit that should not be ignored. According to the survey, 63% of women who experienced breakthrough bleeding discontinued or changed their birth control pill prescription. However, when considering the Pill at the outset, women may overlook breakthrough bleeding as one of the side effects that may occur.

Survey Insights

Previous research has shown that breakthrough bleeding is one of the leading causes for discontinued use of the Pill. In fact, in one study, women who experience bleeding irregularities in their first three months on a birth control pill are almost twice as likely to stop taking it as those who do not experience these symptoms. This new survey offers further insights about breakthrough bleeding and how the condition may affect womens everyday lifestyle:

- Sixty percent of women surveyed agreed that breakthrough bleeding may cause a woman to feel unsure about the effectiveness of the Pill.

- Nearly three-quarters (73%) of women surveyed who had experienced breakthrough bleeding agreed that it would disrupt a woman's sex life. Further, 55% of all women surveyed, regardless of personal experience with this side effect, agreed with this statement.

- More than six in ten (62%) women surveyed agreed that breakthrough bleeding or spotting could cause a woman to feel embarrassed or self-conscious.

- Almost three-quarters (72%) of women surveyed agreed that breakthrough bleeding or spotting would be inconvenient and could have a negative impact on a womans life.

"When evaluating whether or not to take birth control pills, too many women focus on the long-standing myth of perceived weight gain," said Dr. Hilda Hutcherson, OB/GYN and Co-Director of the New York Center for Women's Sexual Health, Columbia Presbyterian Medical Center. However, according to research, as well as my own experience with my patients, breakthrough bleeding is the side effect that is more likely to cause women to stop taking or switch their pill.

What is Breakthrough Bleeding?

Breakthrough bleeding is defined as the bleeding that a woman on the Pill experiences at an unexpected time. Most commonly, it occurs in the first three months on a new pill, and will often cease incidence once the body adjusts to the hormonal dosage. It is important to ensure that women take the Pill consistently, every day, at roughly the same time every day, as not doing so can lead to onset of unscheduled spotting.

"There are many reasons that women bleed or spot mid-cycle while starting out on a new birth control pill most often it is the body adjusting to the Pill," says Dr. Hutcherson. She adds that "breakthrough bleeding doesn't lessen the efficacy of the Pill, but most women are bothered by it and often want a quick fix by switching pills or to other less-effective birth control methods."

What Women Can Do: Choose a Pill that Fits

The survey results demonstrate that breakthrough bleeding is a definite concern among women who are either taking or considering the Pill. In order to choose a pill that suits their lifestyle and addresses these concerns, women need to carefully evaluate their options and consider taking a low-dose birth control pill that offers a low incidence of nuisance side effects while maintaining efficacy. A healthcare professional can help women decide among all the options available and choose the best pill for the patients unique needs and preferences.

"A woman's medical history needs to be the first determining factor when selecting a birth control method, but side effects like breakthrough bleeding that can affect proper use and satisfaction also must be considered," said Dr. Hutcherson. Certain pills, such as ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol), for example, have a low occurrence of breakthrough bleeding and spotting.

It is important for women to understand that the amount and type of estrogen and progestin in birth control pills plays a role in the benefits and side effects associated with different pill types. ORTHO TRI-CYCLEN LO, which was approved by the U.S. Food and Drug Administration in 2002, contains a balance of estrogen and the progestin called norgestimate. This low-dose pill helps prevent pregnancy while providing excellent cycle control and a low incidence of nuisance side effects such as breakthrough bleeding. In a clinical study, fewer than one in five ORTHO TRI-CYCLEN LO users reported these potentially embarrassing side effects in their first month on the Pill.

To learn more about ORTHO TRI-CYCLEN LO, visit www.thepill.com

(1) A nationwide telephone omnibus survey of 1,015 American women 18 years of age and older regarding their experience with the birth control pill and perceptions of breakthrough bleeding. Of those surveyed, 61% either currently use or have used the Pill.

Important Safety Information

Oral contraceptives are not for everybody. Most side effects of the Pill are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke, and heart attacks, and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you're over 35. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect against HIV or sexually transmitted diseases.

Please see full U.S. Prescribing Information for ORTHO TRI-CYCLEN LO enclosed or at www.thepill.com

About the Survey

StrategyOne conducted a nationwide telephone omnibus survey, sponsored by Ortho Women's Health, of 1,015 American women 18 years of age and older regarding their experience with the birth control pill and perceptions of breakthrough bleeding. The interviews were conducted via telephone from October 28, 2004 to November 1, 2004 utilizing the field services of ORC (Opinion Research Corporation). A Computer Assisted Telephone Interviewing (CATI) facility and Random Digit Dialing (RDD) technology were used. The data were analyzed by StrategyOne. The margin of error for the total sample of 1,015 is 3.1% at the 95% level of confidence.

ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol)

ORTHO TRI-CYCLEN LO (norgestimate/ethinyl estradiol) is the only birth control pill with a combination of 25 micrograms of ethinyl estradiol and the progestin, norgestimate. The profile of norgestimate is associated with low rates of nuisance side effects, such as weight gain and acne. ORTHO TRI-CYCLEN LO is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

About Ortho Women's Health

For more than 73 years, Ortho Women's Health, makers of ORTHO TRI-CYCLEN LO and ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), a division of Ortho-McNeil Pharmaceutical, Inc., has listened to women's needs and responded with products and information to help them live healthier lives. Ortho Women's Health, a trusted partner of healthcare professionals, is committed to bringing women the most advanced options in contraception. By delivering superior and innovative products, services, and education, Ortho Women's Health helps empower women to make the right choice for themselves and their bodies. For more information, visit www.orthowomenshealth.com

Please see full U.S Prescribing Information enclosed or at www.thepill.com