SLIDE 1
L I N D A M A I O
Councilmember District 1
2180 Milvia Street, Berkeley, CA 94704 Tel: 510.981.7110 TDD: 510.981.6903 Fax: 510.981.7199 E-mail: lmaior@ci.berkeley.ca.us
TO: Honorable Mayor and Members of the City Council FROM: Councilmembers Linda Maio and Max Anderson SUBJECT: A Brief Presentation to Council on the Off-Label Use of the Drug, Cytotec RECOMMENDATION: That the City Council hear a brief (10-minute) presentation by Maddy Oden on the off-label use of the drug, Cytotec. BACKGROUND: Maddy Oden, a long-time City employee, has asked to make this presentation to Council as part of her foundation’s educational campaign to encourage informed consent regarding the off-label use of the drug Cytotec. Maddy’s daughter, Tatia Oden French, was admitted to an Oakland hospital to deliver her first child in December, 2001. Tatia was in perfect health and the family was looking forward to the delivery of a healthy girl. Against her better judgement, Tatia agreed to have her labor induced, and was administered the drug Cycotec for that purpose. Cytotec is stipualted for the treatment of ulcers, but has been used “off-label” to induce labor. The official description of the drug, Cyctotec, issues the warning that “administration to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has heen reported when Cytotec was administered in pregant women to induce labor or to induce abortion beyond the eighth week of pregnancy.” In spite of this warning, Cytotec is widely used to induce labor. Although the FDA did not approve Cytotec for use in inducing labor, once the FDA approves a drug to treat specific illnesses a physician may use that drug experimentally for other illnesses. This is what happened in Tatia’s case. Within 10 hours of administration of Cytotec both Tatia Odden French and her child had died. Tatia’s uterus was hyper-stimulated by the drug, causing fetal distress and a ambiotic fluid embolism (AFE) was released causing the death of both mother and child. Subsequent to Tatia and son’s death, Maddy and her family started the Tatia Oden French
- Foundation. The Foundation’s aim is to significantly reduce the incidence of maternal mortality
through education, with the specific focus to acquire informed consent before the drug, Cytotec, and
- ther drugs which are used off label, may be used.