I do not understand the pregnancy classification of medications. Where can I find out more?

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I do not understand the pregnancy classification of medications. Where can I find out more?

In the year 1979, the Food and Drug Administration (FDA) established a classification for medications in pregnancy.  This was done to help standardize labeling in pregnancy in regarding potential benefits or risks of the medication. Below you will find information from the FDA explaining these categories.  Some of the important points have been bolded to help draw you attention to the points of the risks.

 

In the year 1979, the Food and Drug Administration (FDA) established a classification for medications in pregnancy.  This was done to help standardize labeling in pregnancy in regarding potential benefits or risks of the medication. Below you will find information from the FDA explaining these categories.  Some of the important points have been bolded to help draw you attention to the points of the risks.     FDA Pregnancy Risk Categories  

A      Adequate, well-controlled studies in pregnant women have NOT shown an increased risk of fetal abnormalities.  

B     Animal studies have revealed no evidence of harm to the fetus; however, 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.  

C     Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or no animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.  

D     Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.  

X    Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities.  The use of the product is contraindicated in women who are or may become pregnant.  

NA     FDA pregnancy rating not available (http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthR...)  

As of the June 2012, these are the names of the insulin available in the United States and their pregnancy category that are not mixtures.   The pregnancy category may change as more research is done on a medication.  You can ask your pharmacist for updates.

Rapid Acting

1.    Insulin glulisine (Apidra) (category C)

2.    Insulin Lispro (Humalog) (category B)

3.    Insulin Aspart (Novolog)  (category B)

 

Regular Insulin

Humulin R (category B)

Novolin R  (category B)

Intermediate Acting

NPH  Humulin R  (category B) NPH  Novolin R    (category B)

 

Long-Acting

1.    Insulin  detemir Levemir (category B)

2.    Insulin glargine  Lantus   (category C) Please consult with your physician to discuss which medication is right for you. 

 

The control of your blood glucose is very important to you and your developing baby. Ask your physician if you can have a referral to a diabetes center in your area.  You can learn about proper procedures to give insulin, the proper time and dose and safety issues.  Other things they will teach include: diabetes in pregnancy, proper nutrition, and understanding your diabetes. You may want to consult with your insurance plan.  Brands of medication may be preferred by your insurance.  Do not forget to ask your pharmacist about any medication questions you have.  Your pharmacist should be an important member of your health care team!