Have you ever felt concern over prescription eye drops or dilation drops used by your eye doctor?
The most common eye drop is rated category c as outlined below. Nursing can be a higher risk period than pregnancy due to drugs being secreted directly through the milk. In our Fort Collins Optometry Practice we usually don’t dilate pupils during these critical time periods unless their are other potential eye problems; like retina changes from diabetes or high blood pressure caused by the pregnancy. Fortunately, there is very little absorption of eye drops into the blood stream and by applying lite pressure to the drainage ducts even this small amount can be largely eliminated. And information about side effects is in process to greatly improve our knowledge.
Currently prescription medications including eye drops are rated by the Federal Drug Administration for safety during pregnancy and nursing. The FDA uses the five following categories:
Pregnancy Category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Pregnancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Pregnancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
While this database has been limited due the unethical nature of testing on humans a new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) should help fill in some of the current gaps. The FDA will study mothers and their children born 2001-2007. This will cover almost one million births at eleven participating centers. Since a large number of these women took some prescription medication during their pregnancy it should greatly to our limited knowledge base in the current rating system.
While eye drops are usually low risk due their minute quantities and limited absorption, these studies should help you rest more comfortably at the eye doctors office and with any other prescription. Of course, when contact lenses used to deliver prescription drugs are introduced in the next year or two they will need to be added to future research like this.