Magazine article Drug Topics

Time Is Now for New Pregnancy Labeling, Says Committee

Magazine article Drug Topics

Time Is Now for New Pregnancy Labeling, Says Committee

Article excerpt

As the 10th anniversary of the Food & Drug Administration's public hearing on pregnancy labeling approached, the Teratology Society once again called for regulations to be enacted on the subject. However, the FDA has estimated that the new system will not become effective before 2010. A new position paper published by public affairs committee of the Teratology Society entided, "Pregnancy Labeling for Prescription Drugs: Ten Years Later," calls for the FDA to implement the new rules immediately.

The current regulations, which have been in place since 1979, require the labeling to include a subsection on the drug's ability to cause birth defects and other effects on reproduction and pregnancy. Products must also be classified under one of five letter categories - A, B, C, D, and X. These classes have come under criticism for being non-specific as to what kind of risk is involved. In 1997 the FDA convened a public hearing during which it became unanimously clear that the regulations were in serious need of revamping.

Two major criticisms were oudined by the FDA. The categories give the impression that the risk increases from one category to the next. This is not necessarily the case. The criterion for categories D, X, and C, to some extent, is based on the risk weighed against its potential benefit. Medications in categories D and X may pose similar risks, but are classified based on different risk/benefit considerations. The second criticism addresses the issue of the pregnancy categories creating "the impression, often mistaken, that the drugs within a given category present similar reproductive risks." There may be in one category medications that have different levels of known risk.

As a result of the hearing, it became clear that pregnancy labeling was a concise and simplistic measure of risk, and, therefore, relied upon by medical professionals incorrectly. In reality, pregnancy-related decisions are more complex than the category designations suggest. "The hope is that the new language will be easier for the physician and pharmacist to interpret," said Anthony R. Scialli, M.D., adjunct professor of obstetrics and gynecology and of biochemistry and molecular biology at Georgetown University Medical Center and author of the position paper. However, this does not necessarily mean it will be compact. Speaking to Drug Topics, he said, "We have learned that compact is not necessarily accurate-what could be more compact than the single letter designation we now have? …

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