TGA slaps pregnancy safety warning on common ADHD drug
The regulator now classifies the stimulant medication as Category D and suggests avoiding scripts for women of childbearing age
Pregnant women should not be prescribed ADHD medications containing methylphenidate because of the heightened risk of fetal cardiac malformations, the TGA warns.
Doctors have been advised against prescribing the stimulant, which is also indicated for narcolepsy, to any woman of childbearing age unless “the potential benefits outweigh the possible risks”.
The medicines watchdog has updated the pregnancy category for the brands Ritalin, Concerta and Artige from Category B3 to Category D.
It says the change is because of “a small increased occurrence of fetal cardiac malformations in women who received methylphenidate during the first trimester of pregnancy compared with non-exposed pregnancies seen in large observational studies”.
