Women should avoid pregnancy for six months after ending treatment with certain anticancer drugs to keep the drugs from harming an embryo or fetus, the FDA recommended in draft guidance.
A man should avoid impregnating a woman for three months after the end of his anticancer treatment, the FDA said.
This information should be included on the labels for the drugs, the guidance said. The labels also should explain any known risks to fertility from use of the drugs, the FDA said. The guidance covers small-molecule drugs, and not biosimilars, vaccines, gene therapies or related products.
The guidance also discussed when studies of a drug’s effects on embryonic and fetal development are required in seeking approval for a new drug. For example, if the drug is toxic and targets rapidly dividing cells, it is presumed to be fatal to an embryo or fetus, and a study is not warranted, the guidance said.