Information for Pharmacists

 























On August 13, 2010, the Food and Drug Administration (FDA) approved a new abortion drug, ella, misleadingly labeled as an Emergency Contraceptive (EC). Watson Pharmaceuticals will distribute ella in the United States as early as October 1, 2010.


ella is chemically and functionally similar to Mifepristone (RU-486), the one FDA-approved abortion drug, and not similar to Plan B (Levonogrestral). Mifepristone and ella share identical modes of action, both are selective progesterone receptor modulators (SPRM) and both can cause the demise of an already implanted embryo.


While the FDA advisory committee did not specifically answer the question concerning the abortive nature of ella, the FDA labeling information clearly states that “alterations to the endometrium that may affect implantation may also contribute to the efficacy.” The labeling information also includes a number of animal studies in which ella terminated established pregnancies. 


ella also poses serious concerns for women’s health. The FDA admits that in the six years following the approval of RU-486, over 1000 adverse events reports were filed, including 232 hospitalizations, 116 blood transfusions and eight deaths. Given the chemical similarities of the drugs, it is likely that they will share similar side effects.


Women and pharmacists have the right to informed consent. Women deserve to know that a prescription drug could cause an abortion if she is pregnant, and could have serious health implications. Pharmacists who are asked to fill prescriptions for ella have an ethical right to know that the drug may cause an abortion as well as health risks for women.