Time is now for new pregnancy labeling, says committee

February 11, 2008
Michael Dear, PharmD
Michael Dear, PharmD

As the 10th anniversary of the FDA's public hearing on pregnancy labeling approached, the Teratology Society once again called for regulations to be enacted.

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 entitled, "Pregnancy Labeling for Prescription Drugs: Ten Years Later," calls for the FDA to implement the new rules immediately.

Two major criticisms were outlined 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.

The most important aspect of the labeling is to be easily understood by both medical professionals and patients. "We hope that the new label language will be clear and straightforward, which should improve comprehensibility. One of the recommendations of the Teratology public affairs committee was that the FDA tests its new label with actual practitioners and consumers to make sure the communication is clear."

These sentiments were echoed by Abraham Dear, B.Pharm., R.Ph., of Dear Drugs Pharmacy in Brooklyn, N.Y. "Pharmacists, and all healthcare workers, need quick access to pregnancy safety information." Dear said that each day he is asked at least once if a certain medication may be used in pregnancy. "The information must be readily available. There is not always time to read through studies and look into all the issues for a risk/benefit analysis. The labeling should retain a categorization to ease the decision-making process."

In 2000, the FDA put out a model label format. The model contains three parts: clinical considerations, risk assessment, and discussion of data. The proposed regulations would likely eliminate the current letter designations, although classifying medication by likelihood of risk would likely be included. Currently, according to the FDA Web site, a major task of the Pregnancy Labeling Task Force is the reassessment of category "C." The new label would be required to state that the drug is teratogenic or has some other adverse effect on the fetus. If there are not any fetal animal or human studies available, then that must be stated and that it is also not known whether the drug can cause fetal harm.

When asked why the FDA still has not revised the pregnancy labeling a decade later, Scialli did not have an answer. "The FDA has transmitted the proposed rule to the Department of Health & Human Services, as required. HHS has been sitting on them."

THE AUTHOR is a pharmacist based in Brooklyn, N.Y.