Luxturna Pregnancy Warnings
Use should be avoided.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Comment: There are no or limited amount of data from the use of this drug in pregnant women.
There are no controlled data in human pregnancy. Animal studies do not indicate direct or indirect harmful effects for reproductive toxicity; no studies have been performed to evaluate the effect on fertility.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
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