FDA clears Berlex Laboratories' Mirena (R), new form of long-acting contraception meets need for U.S. women

December 06, 2000

Montville, NJ, December 6, 2000 - Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) approved MIRENA(R) (levonorgestrel-releasing intrauterine system), a convenient, innovative contraceptive that is as effective in preventing pregnancy as tubal ligation (better than 99 percent) and lasts for five years, or until removed.

Available for 10 years in Europe, MIRENA has been used by approximately two million women worldwide and will be available for the first time in the U.S. in the first quarter of 2001. "Women in European and Asian countries have used MIRENA successfully and safely." says Felicia Stewart, MD, Incoming Chair of the Association of Reproductive Health Professionals. "For many women in the U.S. there has been a limited choice in convenient, reliable and reversible long-acting contraception. MIRENA's availability gives these women a choice they need and deserve."

In addition to preventing pregnancy, MIRENA use may result in a change in bleeding patterns. In the first three to six months following insertion, there may be an increase in intermenstrual bleeding. After this, a woman's period may become shorter and lighter. Some women experience an absence of menstrual bleeding after one year.

MIRENA does not contain estrogen. It delivers a low dose of the progestin levonorgestrel directly to the lining of the uterus. Studies suggest several mechanisms that prevent pregnancy: thickening of cervical mucus, which prevents the passage of sperm, inhibition of sperm mobility and inhibition of endometrial growth. Berlex will market MIRENA under a license from The Population Council, which initially developed the contraceptive.

"MIRENA is the first in a series of major new products that Berlex will bring to market, and its introduction marks the beginning of an expansion in the Berlex position in women's health," said Reinhard Franzen, Vice President and General Manager, Female Healthcare, Berlex Laboratories, Inc. "As a global leader in female health care, we are proud to be able to offer MIRENA to women in this country."

According to the 2000 Gallup Survey of Women's Health and Contraception Methods, a syndicated research service conducted by Multi-sponsor Surveys, Inc. under a license agreement with the Gallup Organization, Inc., nearly 26 million -- or 40 percent -- of women in the U.S. between the ages of 18 and 49 currently use a method of long-acting contraception. Long-acting methods of contraception include sterilization (female and male), injectables, implants and intrauterine devices. Of these women, nearly 80 percent (approximately 21 million) use sterilization, a method that is typically not reversible.

The insertion and removal of MIRENA take only a few minutes and are easily done by a trained health care professional in a doctor's office on an outpatient basis. Health care professionals should be thoroughly familiar with insertion procedures before inserting MIRENA. Once MIRENA is removed, fertility returns rapidly. Approximately eight out of every 10 women who want to become pregnant will become pregnant in the first year after MIRENA is removed.

"My patients are very excited about the prospect of MIRENA," says Mitchell Creinin, MD, Associate Professor and Director of Family Planning and Family Planning Research at the University of Pittsburgh. "Because the progestin in MIRENA is released just within the uterus, it provides very effective contraception with very few effects throughout a woman's body. The insertion of MIRENA is a simple office procedure that really only takes a couple of minutes - a very simple procedure for very effective birth control that can last for up to five years."

"I'm a mom and a wife. I have a full-time job. I sing with a band on the weekends. I just don't have time to think about taking a pill every day," says Michelle Fleissner, one of the first women in the U.S. to use MIRENA. "I know MIRENA works, which means that when my husband and I have intimate time together, we don't have to stop and worry about birth control. Right now, we're not interested in having children. But in two or three years we'll want to, and we like knowing that when we do decide to have children, I can quickly and easily have MIRENA removed."

Appropriate MIRENA candidates are women in stable mutually monogamous relationships with at least one child and no history of pelvic inflammatory disease (PID), and have no history of ectopic pregnancy or a condition that would predispose to ectopic pregnancy.

In clinical studies, side effects of MIRENA were most common during the first months after insertion and subsided during prolonged use. Side effects include, acne, back pain, breast tenderness, headaches, mood changes and nausea.

Like many contraceptives, MIRENA does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Use of IUDs has been associated with an increase risk of PID. A decision to use MIRENA must include consideration of the risks of PID. The highest risk of PID occurs shortly after insertion (usually within the first 20 days thereafter).

Please see the Prescribing Information for further information including Contraindications, Warnings and Precautions.

For more information about MIRENA, please visit www.MIRENA-us.com or call 1-800-BERLEX-2.
Berlex Laboratories, Inc.

Berlex Laboratories is a major presence in the area of Female Healthcare. Currently, marketed products serve the patient in the areas of estrogen replacement therapy (ERT) and contraception. Berlex is committed to conducting research in these and other healthcare areas that are central to a woman's quality of life.

Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), researches, manufactures and markets ethical pharmaceuticals in five strategic areas: Diagnostic Imaging, Female Healthcare, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex business divisions are located in Montville and Wayne, New Jersey, and in Richmond, California. For more information on currently marketed products, please visit www.berlex.com.

Berlex Laboratories, Inc.
Julie Mandell
Manager, Public Relations

Joanne Marion
Investor Relations

Amanda Moulson
Porter Novelli

Porter Novelli

Related Health Articles from Brightsurf:

The mental health impact of pandemics for front line health care staff
New research shows the impact that pandemics have on the mental health of front-line health care staff.

Modifiable health risks linked to more than $730 billion in US health care costs
Modifiable health risks, such as obesity, high blood pressure, and smoking, were linked to over $730 billion in health care spending in the US in 2016, according to a study published in The Lancet Public Health.

New measure of social determinants of health may improve cardiovascular health assessment
The authors of this study developed a single risk score derived from multiple social determinants of health that predicts county-level cardiovascular disease mortality.

BU study: High deductible health plans are widening racial health gaps
The growing Black Lives Matter movement has brought more attention to the myriad structures that reinforce racial inequities, in everything from policing to hiring to maternal mortality.

Electronic health information exchange improves public health disease reporting
Disease tracking is an important area of focus for health departments in the midst of the COVID-19 pandemic.

E-health resource improves men's health behaviours with or without fitness facilities
Men who regularly used a free web resource made significantly more health changes than men who did not, finds a new study from the University of British Columbia and Intensions Consulting.

Mental health outcomes among health care workers during COVID-19 pandemic in Italy
Symptoms of posttraumatic stress disorder, depression, anxiety and insomnia among health care workers in Italy during the COVID-19 pandemic are reported in this observational study.

Mental health of health care workers in china in hospitals with patients with COVID-19
This survey study of almost 1,300 health care workers in China at 34 hospitals equipped with fever clinics or wards for patients with COVID-19 reports on their mental health outcomes, including symptoms of depression, anxiety, insomnia and distress.

Health records pin broad set of health risks on genetic premutation
Researchers from the University of Wisconsin-Madison and Marshfield Clinic have found that there may be a much broader health risk to carriers of the FMR1 premutation, with potentially dozens of clinical conditions that can be ascribed directly to carrying it.

Attitudes about health affect how older adults engage with negative health news
To get older adults to pay attention to important health information, preface it with the good news about their health.

Read More: Health News and Health Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.