Posts Tagged ‘ FDA Drug Classification ’

Having a Baby? Get to Know the FDA Drug Classifications

January 27th, 2010. By Kristine B

Navigating the complex web of drug categories can be complex and overwhelming. Add to that the pregnancy categories and it can be tough to determine just which drugs a pregnant woman should and shouldn’t take. This week, Pleading Ignorance looks at the different FDA pregnancy categories. 

How Does the FDA Classify Drugs for Pregnancy? 

Basically, the categories are based on studies, including animal studies, human studies and/or post-marketing data (reports that have come in after a drug is released on the market). Information taken from those studies—including adverse reactions and potential side effects—is then used to put the drug into a pregnancy category. 

Now, although the categories may seem straight-forward (they are all letters) they aren’t necessarily that simple. Some drugs might have a higher impact on the fetus depending on the point at which they’re taken during pregnancy. Other drugs might have a higher risk of abnormality depending on the dosage taken. When it comes to taking medications while pregnant it’s important for pregnant women to discuss their options with their doctor to determine if the benefits outweigh the risks. 

Also, keep in mind that as increased post-marketing data for a drug becomes available, the FDA can change a drug’s pregnancy category. So, a drug may start out in Category B, for example, but be moved to a Category C if there is enough evidence of an increase in risk after the drug is approved for use. 

FDA Drug Classifications for Pregnancy

So, here’s how it breaks down: 

Category A: Means that controlled studies have found no risk to the fetus when the mother takes the medication during any trimester of pregnancy. 

Category B: Means that controlled studies in pregnant women have not shown an increased risk of fetal abnormalities, although some adverse findings have occurred in animals. It can also mean that there are no adequate human studies but animal studies show no fetal risk. There is a remote possibility of fetal harm. 

Category C: Means that there is a risk. Either there are not enough adequate human studies, but animal studies have shown a risk or there are not adequate animal studies. There is a chance of fetal harm but benefits may outweigh the risks.  Read the rest of this entry »

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