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ARTICLE |

Teratogenic Effect of Meclizine, Cyclizine, and Chlorcyclizine FREE

Joseph F. Sadusk, Jr., MD; Paul A. Palmisano, MD
[+] Author Affiliations

Read in part before the American Academy of Pediatrics, Chicago, Oct 26, 1965.

Reprint requests to Food and Drug Administration, US Department of Health, Education and Welfare, Washington, DC 20204 (Dr. Sadusk).


From the Bureau of Medicine, Food and Drug Administration, US Department of Health, Education and Welfare, Washington, DC.


JAMA. 1965;194(9):987-989. doi:10.1001/jama.1965.03090220043011
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On April 22, 1965, the second meeting of an Ad Hoc Advisory Committee on the Teratogenic Effect of Certain Drugs was held under the auspices of the Food and Drug Administration in order to review available data related to the teratogenic effect of meclizine, cyclizine, and chlorcyclizine and to make recommendations regarding the dispensing status and labeling directions of drug articles containing the subject compounds. On July 27, 1965, the recommendations resulting from that meeting were transmitted to the medical director of the FDA by the chairman of the committee. (A list of the members appears at the end of this paper.) The present communication offers a summary of the scientific and clinical background considerations upon which the recommendations of the committee were based, and final decisions of the FDA in the matter.

Background Considerations  In the latter part of 1962, attention was drawn to the possibility of human fetal

REFERENCES

Watson, G.I.:  Meclozine ("Ancoloxin") and Foetal Abnormalities , Brit Med J 2:1446 ( (Dec 1) ) 1962;.
 Drugs Under Suspicion , editorial, Brit Med J 2:1456 ( (Dec 1) ) 1962;.
 Foetal Abnormalities, Notes and News , Lancet 2:1177 ( (Dec 1) ) 1962;.
David, A., and Goodspeed, A.H.:  Meclizine and Foetal Abnormalities , Lancet 2:1222 ( (Dec 8) ) 1962;.
Smithells, R.W.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 2:1539 ( (Dec 8) ) 1962;.
Diggory, P.L.C., and Tomkinson, J.S.:  Meclizine and Foetal Abnormalities , Lancet 2:1222 ( (Dec 8) ) 1962;.
Meclozine:  Statement of the Council of the Pharmaceutical Society of Great Britain . Pharm J 189:564 ( (Dec 15) ) 1962;.
Carter. M.P., and Wilson, F.W.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 2:1609 ( (Dec 15) ) 1962;.
James, J.R.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:59 ( (Jan 5) ) 1963;.
Gallagher, C.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:121-122 ( (Jan 12) ) 1963;.
Watson, G.I.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:122 ( (Jan 12) ) 1963;.
David, A., and Goodspeed, A.H.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 1:121 ( (Jan 12) ) 1963;.
Kirman, B.H.:  "Ancoloxin" and Foetal Abnormalities . Brit Med J 1:265 ( (Jan 26) ) 1963;.
Mellin, G.W., and Katzenstein, M.:  Meclozine and Fetal Abnormalities . Lancet 1:222 ( (Jan 26) ) 1963;.
Martin-Nahon, L.:  "Ancoloxin" and Fetal Abnormalities . Brit Med J 1:331 ( (Feb 2) ) 1963;.
Hopkins, P., and Robertson, D.:  The Effect of "Ancolan" and Other Drugs in Early Pregnancy , Med J Austr 1:329-330 ( (March 2) ) 1963;.
Mellin, G.W.:  Fetal Life Study, Meclozine and Other Drugs , Bul Soc Roy Belg Gynec Obstet (special issue) 33:79-86, 1963;.
Smithells, R.W., and Chinn, E.R.:  Meclozine and Foetal Abnormalities , Brit Med J 1:1678 ( (June 22) ) 1963;.
Petersson, F.:  Meclozine and Congenital Malformations . Lancet 1:1221 ( (May 30) ) 1964;.
 Cyclizine, Possible Risk in Pregnancy, Medical News , Brit Med J 1:828 ( (March 23) ) 1963;.
 Drugs and Doctors , editorial, Brit Med J 1:835 ( (March 30) ) 1963;.
McBride, W.:  Cyclizine and Congenital Abnormalities , Brit Med J 1:1157 ( (April 27) ) 1963;.
King, C.T.G.:  Teratogenic Effects of Meclizine Hydrochloride on the Rat , Science 141:353-355 ( (July 26) ) 1963;.
King, C.T.G.; Weaver, S.A.; and Narrod, S.A.:  Antihistamines and Teratogenicity in the Rat , J Pharmacol Exp Ther 147: 391-398 ( (March) ) 1965;.
Narrod, S.A.; Wilk, A.L.; and King, C.T.G.:  Metabolism of Meclizine in the Rat , J Pharmacol Exp Ther 147:380-384 ( (March) ) 1965;.
Yerushalmy, J., and Milkovich, L.:  The Evaluation of the Teratogenic Effect of Meclizine in Man , Amer J Obstet Gynec 93:553-562 ( (Oct) ) 1965;.
Trasler, D.G.:  Aspirin-Induced Cleft Lip and Other Malformations in Mice , Lancet 1:606 ( (March 13) ) 1965;.
Sadusk, J.F., Jr.:  The Definition of Efficacy of a Drug Under the Law , Bull Amer Coll Physicians 5:328-331 ( (Nov) -Dec) 1964;.

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Watson, G.I.:  Meclozine ("Ancoloxin") and Foetal Abnormalities , Brit Med J 2:1446 ( (Dec 1) ) 1962;.
 Drugs Under Suspicion , editorial, Brit Med J 2:1456 ( (Dec 1) ) 1962;.
 Foetal Abnormalities, Notes and News , Lancet 2:1177 ( (Dec 1) ) 1962;.
David, A., and Goodspeed, A.H.:  Meclizine and Foetal Abnormalities , Lancet 2:1222 ( (Dec 8) ) 1962;.
Smithells, R.W.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 2:1539 ( (Dec 8) ) 1962;.
Diggory, P.L.C., and Tomkinson, J.S.:  Meclizine and Foetal Abnormalities , Lancet 2:1222 ( (Dec 8) ) 1962;.
Meclozine:  Statement of the Council of the Pharmaceutical Society of Great Britain . Pharm J 189:564 ( (Dec 15) ) 1962;.
Carter. M.P., and Wilson, F.W.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 2:1609 ( (Dec 15) ) 1962;.
James, J.R.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:59 ( (Jan 5) ) 1963;.
Gallagher, C.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:121-122 ( (Jan 12) ) 1963;.
Watson, G.I.:  "Ancoloxin" and Foetal Abnormalities , Brit Med J 1:122 ( (Jan 12) ) 1963;.
David, A., and Goodspeed, A.H.:  "Ancoloxin" and Fetal Abnormalities , Brit Med J 1:121 ( (Jan 12) ) 1963;.
Kirman, B.H.:  "Ancoloxin" and Foetal Abnormalities . Brit Med J 1:265 ( (Jan 26) ) 1963;.
Mellin, G.W., and Katzenstein, M.:  Meclozine and Fetal Abnormalities . Lancet 1:222 ( (Jan 26) ) 1963;.
Martin-Nahon, L.:  "Ancoloxin" and Fetal Abnormalities . Brit Med J 1:331 ( (Feb 2) ) 1963;.
Hopkins, P., and Robertson, D.:  The Effect of "Ancolan" and Other Drugs in Early Pregnancy , Med J Austr 1:329-330 ( (March 2) ) 1963;.
Mellin, G.W.:  Fetal Life Study, Meclozine and Other Drugs , Bul Soc Roy Belg Gynec Obstet (special issue) 33:79-86, 1963;.
Smithells, R.W., and Chinn, E.R.:  Meclozine and Foetal Abnormalities , Brit Med J 1:1678 ( (June 22) ) 1963;.
Petersson, F.:  Meclozine and Congenital Malformations . Lancet 1:1221 ( (May 30) ) 1964;.
 Cyclizine, Possible Risk in Pregnancy, Medical News , Brit Med J 1:828 ( (March 23) ) 1963;.
 Drugs and Doctors , editorial, Brit Med J 1:835 ( (March 30) ) 1963;.
McBride, W.:  Cyclizine and Congenital Abnormalities , Brit Med J 1:1157 ( (April 27) ) 1963;.
King, C.T.G.:  Teratogenic Effects of Meclizine Hydrochloride on the Rat , Science 141:353-355 ( (July 26) ) 1963;.
King, C.T.G.; Weaver, S.A.; and Narrod, S.A.:  Antihistamines and Teratogenicity in the Rat , J Pharmacol Exp Ther 147: 391-398 ( (March) ) 1965;.
Narrod, S.A.; Wilk, A.L.; and King, C.T.G.:  Metabolism of Meclizine in the Rat , J Pharmacol Exp Ther 147:380-384 ( (March) ) 1965;.
Yerushalmy, J., and Milkovich, L.:  The Evaluation of the Teratogenic Effect of Meclizine in Man , Amer J Obstet Gynec 93:553-562 ( (Oct) ) 1965;.
Trasler, D.G.:  Aspirin-Induced Cleft Lip and Other Malformations in Mice , Lancet 1:606 ( (March 13) ) 1965;.
Sadusk, J.F., Jr.:  The Definition of Efficacy of a Drug Under the Law , Bull Amer Coll Physicians 5:328-331 ( (Nov) -Dec) 1964;.
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