Onfi and Pregnancy

It is unclear if Onfi (clobazam) is safe for use in women who are expecting. In preliminary animal studies, even normal doses of the drug appeared to increase the risk for birth defects. However, the risks associated with using Onfi during pregnancy may outweigh the risks of having uncontrolled seizures during pregnancy. Talk to your healthcare provider about your particular situation.

Can Pregnant Women Take Onfi?

Onfi™ (clobazam) is a prescription medicine approved to treat Lennox-Gastaut syndrome seizures. Based on the results of animal studies, this medication may not be safe for use in pregnant women.
 

What Is Pregnancy Category C?

Onfi is classified as a pregnancy Category C drug. 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 C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Preliminary studies in animals suggest that Onfi, even at normal doses, may increase the risk for birth defects. However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
 
For women taking Onfi for seizures, it is important to understand that uncontrolled seizures are also dangerous during pregnancy. The risks of taking this drug during pregnancy must be weighed against the risks of uncontrolled seizures.
 
(Click Epilepsy and Pregnancy for more information about pregnant women with epilepsy.)
 
Stopping Onfi too quickly can cause dangerous withdrawal symptoms. Similar symptoms are possible in a newborn who has been constantly exposed to Onfi in the womb.
 
Pregnancy and Pain

Onfi Medication Information

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