Drug Topics - February 11, 2008 - (Page HSE11) www.drugtopics.com FEBRUARY 11, 2008 DRUG TOPICS HSE 11 Clinical Practice Time is now for new pregnancy labeling, says committee Michael Dear, Pharm.D. s the 10th anniversary of the Food & Drug Ad- Georgetown University Medical Center and author of ministration’s public hearing on pregnancy label- the position paper. However, this does not necessarily ing approached, the Teratology Society once mean it will be compact. Speaking to Drug Topics, he again called for regulations to be enacted on the subject. said, “We have learned that compact is not necessariHowever, the FDA has estimated that the new system ly accurate—what could be more compact than the will not become effective before 2010. A new position single letter designation we now have?” paper published by public affairs committee of the TerThe most important aspect of the labeling is to be atology Society entitled, “Pregnancy Labeling for Pre- easily understood by both medical professionals and scription Drugs: Ten Years Later,” calls for the FDA to patients. “We hope that the new label language will be implement the new rules immediately. clear and straightforward, which should improve comThe current regulations, which have been in place prehensibility. One of the recommendations of the since 1979, require the labeling to include a subsection Teratology public affairs committee was that the FDA on the drug’s ability to cause birth defects and other ef- tests its new label with actual practitioners and confects on reproduction and pregnancy. Products must sumers to make sure the communication is clear.” also be classified under one of five letter categories — A, These sentiments were echoed by Abraham Dear, B, C, D, and X. These classes have come under criticism B.Pharm., R.Ph., of Dear Drugs Pharmacy in Brooklyn, for being non-specific as to what kind of risk is involved. N.Y. “Pharmacists, and all healthcare workers, need In 1997 the FDA convened a public hearing during quick access to pregnancy safety information.” Dear said which it became unanimously clear that the regulations that each day he is asked at least once if a certain medwere in serious need of revamping. ication may be used in pregnancy. “The information Two major criticisms were outlined by the FDA. The must be readily available. There is not always time to categories give the impression that the risk increases read through studies and look into all the issues for a from one category to the next. This is not necessarily the risk/benefit analysis. The labeling should retain a categocase. The criterion for categories D, X, and C, to some rization to ease the decision-making process.” extent, is based on the risk weighed against its potential In 2000, the FDA put out a model label format. The benefit. Medications in categories D and X may pose model contains three parts: clinical considerations, risk assimilar risks, but are classified based on different sessment, and discussion of data. The proposed regularisk/benefit considerations. The second criticism ad- tions would likely eliminate the current letter designadresses the issue of the pregnancy categories creating tions, although classifying medication by likelihood of “the impression, often mistaken, that the drugs within a risk would likely be included. Currently, according to the given category present similar reproductive risks.” There FDA Web site, a major task of the Pregnancy Labeling may be in one category medications that have different Task Force is the reassessment of category “C.” The new levels of known risk. label would be required to state that the drug is teratoAs a result of the hearing, it became clear that preg- genic or has some other adverse effect on the fetus. If there nancy labeling was a concise and simplistic measure of are not any fetal animal or human studies available, then risk, and, therefore, relied upon by medical profes- that must be stated and that it is also not known whether sionals incorrectly. In reality, pregthe drug can cause fetal harm. nancy-related decisions are more When asked why the FDA still Existing pregnancy complex than the category designahas not revised the pregnancy labelclassifications: tions suggest. “The hope is that the ing a decade later, Scialli did not A new language will be easier for the have an answer. “The FDA has B physician and pharmacist to intertransmitted the proposed rule to C pret,” said Anthony R. Scialli, the Department of Health & HuM.D., adjunct professor of obstetman Services, as required. HHS has D rics and gynecology and of biobeen sitting on them.” X chemistry and molecular biology at THE AUTHOR is a pharmacist based in Brooklyn, N.Y. A http://www.drugtopics.com
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