OptiPranolol and Pregnancy

Animal studies on pregnancy and OptiPranolol indicate that the medication could be harmful to a developing fetus. Giving the eye drop by mouth to pregnant rats increased the risk of miscarriages and delayed development (although the same may not be true in humans). If you are using this medication and pregnancy occurs, talk to your healthcare provider about the potential risks.

Is OptiPranolol Safe During Pregnancy?

OptiPranolol® (metipranolol) is a prescription eye medication approved for the treatment of high eye pressure and open angle glaucoma. It is a beta blocker. Even though it is an eye drop, a significant amount of the medication may be absorbed into the bloodstream.
 
It is not known if this medication is safe for use during pregnancy. Animal studies indicate that the medication could be harmful to a developing fetus.
 

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.
 
OptiPranolol was given a pregnancy Category C rating because of problems seen in animal studies. Giving OptiPranolol by mouth to pregnant rats increased the risk of miscarriages and delayed development. No evidence of an increased risk of birth defects was seen.
 
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 pregnant woman outweigh any possible risks to the unborn child.
 
(OptiPranolol and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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