National Pregnancy Registry for Atypical Antipsychotics
Posted May 28 2009 11:29pm
Here's a whole article on studies being planned for on drugs that you may be prescribed for symptoms of severe PPD, especially if you are experiencing anxiety, panic or insomnia... The team at the MGH Center for Women’s Mental Health is pleased to announce the establishment of the National Pregnancy Registry for Atypical Antipsychotics. This new research study will address the dearth of available prospective data on the safety of the use of atypical antipsychotics during pregnancy and their potential effects on the developing fetus and mother. The atypical antipsychotics most frequently prescribed in the United States include Abilify (aripiprazole), Clozaril (clozapine), Geodon (ziprasidone), Invega (paliperidone), Risperdal (risperidone), Seroquel (quetiapine), and Zyprexa (olanzapine). These medications are being increasingly used as primary or adjunctive therapy across a wide range of psychiatric disorders including bipolar disorder, schizophrenia, unipolar ! depression, anxiety disorders and other psychotic illnesses. These disorders are highly prevalent in women during the reproductive years. Therefore, information regarding the reproductive safety for these medications is urgently needed.
Currently, there is no consensus for systematic methods to collect such information, and the effect has been a literature that is often confusing and inconsistent in findings. To date, most of the data collected on the safety of psychotropic medications during pregnancy is from small, observational case studies or industry reports, which do not provide definitive information about reproductive safety. The majority of medication trials exclude pregnant women from enrollment or if a woman becomes pregnant during a trial, she is withdrawn from the study. Furthermore, there is no formal mandate from the U.S. Food and Drug Administration (FDA) that such information be systematically collected. Therefore, important drug safety information is often not available to women who must often face the clinical dilemma of whether to continue or discontinue their medica! tion during pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is the first hospital-based pregnancy registry for atypical antipsychotics in America to systematically and prospectively evaluate pregnancy outcomes. It is modeled after the North American Antiepileptic Drug Pregnancy Registry, which is in its eleventh year at the Massachusetts General Hospital.
Pregnant women who are currently taking one or more atypical antipsychotics are eligible and encouraged to enroll in the Registry by calling our toll free number (1-866-961-2388). Information regarding maternal and neonatal outcomes is obtained by study staff over three prospective phone interviews:
Interview 1: The first interview is conducted early in pregnancy (ideally during the first 16 weeks of pregnancy), and takes approximately 20 minutes. This interview records baseline information about the status of a woman’s pregnancy, including her medical history, psychiatric information, current and past pregnancy information, habits, and demographic information.
Interview 2: The second interview is conducted during the seventh month of pregnancy, and takes approximately 10 minutes. Any change in medication is recorded, as are changes in the woman’s physical and psychiatric health and her pregnancy.
Interview 3: The third interview is conducted after the woman delivers her baby, and takes approximately 10 minutes. Again, any changes in medication or health are recorded. Detailed information about the pregnancy and delivery is recorded to evaluate both maternal and neonatal health outcomes. Following the final interview, and with the woman’s consent, a copy of her medical records is obtained for review by a staff teratologist, a specialist in the effects of exposures and infant outcomes.
The primary aim of the Registry is to estimate the frequency of major malformations in infants exposed to atypical antipsychotics, but we are also interested in examining maternal and neonatal outcomes associated with the use of these medications during pregnancy. Major malformation rates among Registry participants will be compared to rates among women who are not exposed to atypical antipsychotics during pregnancy.
We at the Massachusetts General Hospital Center for Women’s Mental Health are very pleased to launch the National Pregnancy Registry for Atypical Antipsychotics. Over the past decade, pregnancy registries have emerged as an effective and efficient method for collecting important reproductive safety data. It is our hope that the inauguration of this important research initiative represents a first step in gathering critical safety information on the use of atypical antipsychotics during pregnancy. In the near future, pregnant women treated with this class of medications will be the beneficiaries of such information and therefore be better informed when making clinical decisions about treatment during pregnancy.