Regulatory Focus™ > News Articles > Toxicology Program to Assess Chemotherapy Products Used During Pregnancy

Toxicology Program to Assess Chemotherapy Products Used During Pregnancy

Posted 15 August 2012 | By

The National Toxicology Program (NTP), a joint program among several federal agencies that works to assess the toxicological profiles of many chemicals, has announced a meeting to review a draft monograph on the effects of chemotherapy administered during pregnancy.

NTP said it estimates between 1 in 6000 and 1 in 1000 pregnant women will need to undergo chemotherapy during the course of a pregnancy, and noted "nearly all" chemotherapy agents are toxic to the development of a fetus.

The NTP's Office of Health Assessment and Translation (OHAT) has prepared what it is calling a, "Comprehensive draft NTP Monograph that summarizes the effects on development and pregnancy outcomes of gestational exposure to 52 cancer chemotherapeutic agents, individually and/or in combination therapy as reported in the peer-reviewed literature."

In addition to the 52 therapies, OHAT said it has also conducted an assessment of seven frequently diagnosed cancers along with the mechanisms of action of chemotherapeutic agents used to combat them.

NTP said its 1 October 2012 meeting will invite public comment and written comments on the draft monograph, and will subsequently publish a report on the meeting to inform future discussion on the draft monograph.


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