Wilmington, DE – January 26, 2004 — The Case Management Society of America (CMSA) announced today the results of a national survey showing that 39 percent of asthmatic women who have been pregnant discontinued using their asthma medication, reduced their dosage, or did both when expecting. However, the survey found that nearly half (46%) of those using an inhaled corticosteroid (ICS) to manage their asthma would plan to continue their ICS during pregnancy if it had a U.S. Food and Drug Administration (FDA) Category B pregnancy rating.

The FDA has a pregnancy category rating system which serves as a guideline to help physicians decide whether to prescribe a particular drug for a pregnant woman, and may give physicians greater levels of confidence in prescribing the drug for women of childbearing age. Similarly, these guidelines can give expectant mothers greater measures of comfort in using a specific drug during pregnancy.

Entitled "Women Breathing Better," the CMSA survey explored attitudes and experiences regarding asthma medication in 501 women of childbearing age (18- to 44-years old) with asthma . Questions focused in part on women's perceived benefits and risks of using ICSs and other asthma medication prior to and during pregnancy, and their knowledge of the FDA's pregnancy category rating system for medications. The survey was conducted in 2003, by Harris Interactive®, and sponsored by AstraZeneca. Among the survey's key findings were:

• Most women (82%) who use ICSs to manage asthma are concerned about birth defects if they become pregnant. More than one in three (36%) currently taking an ICS say their concern is strong enough to discontinue use of the drug during pregnancy, an action that is contrary to the National Heart, Lung, and Blood Institute (NHLBI) recommendation for effective control of persistent asthma.
• More than half (59%) of respondents are not aware of the FDA's pregnancy category rating.
• When informed of the availability of an ICS with a Pregnancy Category B rating based on clinical studies showing no increased risk for congenital malformations (birth defects) from use of the medication during early pregnancy, nearly half (46%) said they would plan to continue their ICS during pregnancy if it had a Pregnancy Category B rating.

"This survey demonstrates that there is a clear need for better education on asthma treatment during pregnancy for women of childbearing age -- a need which can be met through the collaborative efforts of the patient, physician, and case manager," said Karen Chambers, 2002-2003 president and member, Board of Directors, Case Management Society of America." Lacking information about the actual health risks of stopping their asthma medication, expectant mothers may make asthma treatment decisions which put themselves and their unborn baby at risk."

Importance of Communication with Health Care Providers
Survey findings show that less than one in five (19%) women of childbearing age have discussed with their doctor the need to continue taking their asthma medication during pregnancy, and only 29 percent of asthmatic women who had been pregnant in the past reported having this discussion. Of those who discontinued using their asthma medication, reduced their dosage, or did both when expecting, 33 percent did so without discussing it first with their prescribing physician or obstetrician. However, 87 percent of survey respondents said they would be more likely to continue using their asthma medication during pregnancy if their obstetrician or primary physician recommends it.

Asthma and Pregnancy
According to the American College of Allergy, Asthma and Immunology, if asthma is not controlled properly during pregnancy, complications for the expectant mother may include high blood pressure and preeclampsia. Complications for the baby may include increased risk of premature birth, low birth weight and stillbirth . NHLBI asthma guidelines state that during pregnancy, it is essential to maintain sufficient lung function and blood oxygenation to ensure an adequate supply of oxygen to the fetus .

ICS Medication with the FDA Pregnancy Category B Rating Approved for Adults
The NHLBI guidelines state the importance of treating persistent asthma in adults with inhaled corticosteroids and consider inhaled corticosteroids to be the most effective long-term anti-inflammatory therapy for the control of persistent asthma .

In 2001, the FDA approved the first Pregnancy Category B rating for an inhaled corticosteroid, Pulmicort Turbuhaler® (budesonide inhalation powder). To date, all other inhaled corticosteroids approved for use in adults are classified as Pregnancy Category C.

The FDA based its pregnancy rating label change for Pulmicort Turbuhaler on a review of data from three Swedish registries covering over 2,000 births from 1995 -1997 (Swedish Medical Birth Registry; Registry of Congenital Malformations and Child Cardiology Registry) that indicated no increased risk for congenital malformations from use of inhaled budesonide during early pregnancy -- the period when most major organ malformations can occur.

Studies of pregnant women have shown that inhaled budesonide, the active compound in Pulmicort Turbuhaler, does not increase the risk of abnormalities when administered during pregnancy. Despite adverse effects in animal reproductive studies, it would appear that the possibility of fetal harm is remote (see PRECAUTIONS in full Prescribing Information for Pulmicort Turbuhaler). Nevertheless, because studies in humans cannot rule out the possibility of harm, inhaled budesonide should be used in pregnancy only if clearly needed.

Pulmicort Turbuhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Pulmicort Turbuhaler is NOT indicated for the relief of acute bronchospasm.

Common adverse events associated with Pulmicort Turbuhaler include respiratory infection, headache, oral thrush, pharyngitis, voice alteration and sinusitis. It is important that the potential benefits and risks associated with inhaled corticosteroids be well understood, especially in pregnant women. Patients on inhaled corticosteroids should have the dose reduced to the lowest amount necessary to maintain effective asthma control, and should be monitored for any potential side effects.

If patients are switched to Pulmicort Turbuhaler from systemic steroids (tablets), they need to be carefully monitored by their doctors to avoid health risks associated with stopping the use of systemic steroids. (CAUTION: Adrenal insufficiency may occur when transferring patients from systemic steroids. See WARNINGS in the full Prescribing Information).

For a copy of the full Prescribing Information for Pulmicort Turbuhaler, call 1-800-237-8898 or visit www.pulmicortinfo.com.

1. To qualify for the study, respondents self-reported that they are between 18- and 44-years-old, have asthma, and are covered by managed care.
2. "Understanding Asthma: Pregnancy Facts," American College of Allergy, Asthma and Immunology (ACAAI).
3. "Practical Guide for the Diagnosis and Management of Asthma," National Institutes of Health, National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program, October 1997, p 16.
4. "Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma," National Institutes of Health, National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program, July 1997, p 59.