Is Cosopt Safe During Pregnancy?
It is important to understand that even though Cosopt is an eye drop, some of the medication reaches the bloodstream and could, therefore, affect a developing fetus.
What Is Pregnancy Category C?
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 studied in pregnant humans, but do appear to cause harm to the fetus 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.
Cosopt was given a pregnancy Category C rating because of problems seen in animal studies. Giving pregnant rabbits very high doses of
dorzolamide (one of the active ingredients in Cosopt) caused malformation in the fetal vertebrae. These doses were also high enough to cause metabolic acidosis (overly acidic bodily fluids) and poor weight gain in the mother rabbits and low fetal weight. Lower doses (which were still several times higher than recommended) did not cause such problems.
Giving enormous doses of
timolol (the other active ingredient in Cosopt) to pregnant animals increased the risk of miscarriages. However, these doses were extremely high (up to 142,000 times the equivalent maximum recommended dosage used in humans).
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 the unborn child.
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