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FDA Use in Pregnancy Ratings [1,2,3]

The Food and Drug Administration (FDA) created the rating system below   to simplify the risk-benefit information  for a given drug. 

Unfortunately this system oversimplifies the issues important to prescribing a medication to a pregnant patient. "The letters imply a gradation of risk that doesn't necessarily exist, says the FDA's Kweder. People falsely assume that drugs labeled as category X pose the most risk in pregnancy and drugs labeled as A pose the least. But X reflects a benefit-risk judgment, and drugs in that category may be no more toxic than drugs called C or D... Some drugs, such as oral contraceptives, land in Category X simply because there is no reason to use them in pregnancy" [2]

The U.S. Food and Drug Administration (FDA) has recommended the elimination of the current pregnancy categories A, B, C, D, and X. In place of the current system the FDA has proposed that the pregnancy and lactation subsections of labeling should include a summary, which summarizes the risks of the medicine to the developing baby (fetus) or breast-feeding infant, and a discussion of the data supporting that summary [4] .

CATEGORY INTERPRETATION
      A Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy.
      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 in any trimester.
      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 Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus.

However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

      X Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks.

The use of the product is contraindicated in women who are or may become pregnant.

 

REFERENCES
1. Physician's Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2003: 3539
1.
2. Meadows M.. Pregnancy and the drug dilemma. FDA Consum. 2001 May-Jun;35(3):16-20. PMID: 11458544
.
3. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002.
4
. Pregnancy & Lactation Labeling. U.S. Department of Health & Human Services 12/18/2009 .Accesssed 1/27/09

Created: 11/11/2012 Mark A Curran, M.D.

 


 

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