June 22, 1984

More cautionary labeling appears on isotretinoin

JAMA. 1984;251(24):3208-3209. doi:10.1001/jama.1984.03340480008003

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The Food and Drug Administration and Roche Laboratories, Nutley, NJ, have agreed on more cautionary labeling for the company's isotretinoin (Accutane) anti-acne product. The laboratories are a division of Hoffmann-LaRoche Inc.

The labeling contains two boxed warnings that were not in the earlier version. These emphasize in boldface type that the drug should not be used by women who are pregnant or who have immediate plans to become pregnant.

The warning also draws attention to the association of isotretinoin with cases of pseudotumor cerebri, pointing out that early signs of this disorder include papilledema, headache, nausea and vomiting, and visual disturbances.

Further, in what is held by some to be an unusual move, the FDA has advised the blood banking community that patients receiving isotretinoin should not donate blood for transfusion for 30 days after use of the drug. The director of the Division of Blood