In previous studies involving theophylline and pregnancy, the drug caused birth defects and miscarriages when it was given to pregnant animals. Because of these potential risks, theophylline should be prescribed to a pregnant woman only if her healthcare provider believes that the benefits outweigh any possible risks to the unborn child. If you are taking theophylline and pregnancy occurs, you should talk with your healthcare provider.
Is Theophylline Safe During Pregnancy?
Theophylline may not be safe for women who are pregnant. In previous animal studies involving theophylline and pregnancy, the drug caused birth defects and miscarriages.
Theophylline and Pregnancy Category C
The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant mice, theophylline caused cleft palate and finger or toe birth defects. Theophylline also caused small jaws, small or short limbs, and miscarriages.
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 her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child.
Final Thoughts on Theophylline and Pregnancy
If you are pregnant or thinking of becoming pregnant while taking theophylline for asthma, let your healthcare provider know. He or she will consider both the benefits and risks of using theophylline during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Elixophyllin [package insert]. St. Louis, MO: Forest Pharmaceuticals, Inc.;2004 September.
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