Intuniv and Pregnancy
Intuniv (guanfacine ER) is generally considered safe for pregnant women. In clinical studies, no problems were reported when pregnant animals were given the active ingredient in doses equivalent to four to six times the maximum human dosage. If you become pregnant while taking Intuniv, your healthcare provider will consider the drug's benefits and risks before making a recommendation.
Is It Safe to Take Intuniv While Pregnant?Intuniv™ (guanfacine ER) is a prescription medication approved to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. Based on the results of animal studies, Intuniv is probably safe for use in pregnant women, although the full risks are currently unknown.
What Is Pregnancy Category B?
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Animal studies suggested that doses of guanfacine (the active ingredient in Intuniv) up to four to six times the equivalent maximum dosage in humans did not cause any problems. Very high doses (equivalent to 20 times the maximum recommended human doses) did decrease fetal survival, but also caused toxicity in the pregnant animals themselves.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.