Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs.
BACKGROUND
Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients.


OBJECTIVE
To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling.


METHODS
The electronic version of the 2001 and 2002 PDR was searched for 'pregnancy category X' products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated.


RESULTS
One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes.


CONCLUSIONS
This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.
Uhl
Kathleen
K
US Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20852, USA. uhlk@cder.fda.gov
Kennedy
Dianne L
DL
Kweder
Sandra L
SL
D000075202:Contraindications; D004346:Drug Information Services; D004348:Drug Labeling; D005260:Female; D006801:Humans; D004364:Pharmaceutical Preparations / Q000145:classification*; D011247:Pregnancy; D012014:Reference Books, Medical; D012308:Risk Management; D013723:Teratogens / Q000145:classification / Q000633:toxicity; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations; D013723:Teratogens