Agrylin Use In Pregnancy & Lactation

Pregnancy: Data on a limited number (14) of exposed pregnancies indicate no adequate evidence supporting safe use of anagrelide on pregnancy or health of the fetus or development of the child if anagrelide is inadvertently taken during the first three months of pregnancy. Three (3/14) patients had a pregnancy of unknown outcome. Four (4/14) patients underwent termination of the pregnancy due to medical complications not associated with anagrelide. One (1/14) patient had a spontaneous abortion. The information is from clinical trial and pharmacovigilance reporting. To date, no other relevant epidemiological data are available.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Use of Agrylin during pregnancy is not recommended. If Agrylin is used during pregnancy, or if the patient becomes pregnant while using the drug, she should be advised of the potential risk to the fetus.
Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide.
Lactation: It is not known whether anagrelide hydrochloride is excreted in milk. Since many drugs are excreted in human milk and because of the potential for adverse reactions in breast-feeding infants, mothers should discontinue breast-feeding when taking Agrylin.