Tretinoin teratogenicity

Jorgensen KD (1998) Teratogenic activity of tretinoin in the Gottingen minipig. Scand J Lab Anim Sci 25(suppl l) 235-243... 

Embryotoxicity/teratogenicity is the major drawback in the therapeutic use of retinoids. The exposure of the fetus during the first trimester with oral retinoids is known to produce characteristic malformations.93 There have also been case reports about malformations associated with retinoid embryopathy after the mother had used tretinoin topically during the first trimester of pregnancy 94-96... 

There are few data about the safety of topical retinoids during pregnancy. The risk of teratogenicity of topical tretinoin, if any, appears to be minimal (SEDA-18, 164) (109). However, there is a case report (110). 

Adverse reactions to tretinoin—snch as skin irritation, erythema, and peeling—will vary depending on individual skin type and dosage form used. AUergic contact dermatitis is rare and much less common than with BPO. Teratogenicity risk with topical retinoids remains controversial. 

Eckhoff, C. Chari, S. Kromka, M. Staudner, H. Juhasz, L. Rudiger, H. Agnish, N. Teratogenicity and transplacental pharmacokinetics of 13-cis-retinoic acid in rabbits. Toxicol.Appl.Pharmacol., 1994, 125, 34-41 [plasma acitretin (IS) SPE column temp 35 tissue extracted metabolites, isotretinoin, tretinoin]... 

The first part of this chapter is devoted to the results of toxicologic, mutagenic, teratogenic, and carcinogenic studies with isotretinoin and etretinate when appropriate, a comparison with results for retinol and tretinoin (all-(rans-retinoic acid) is presented. The second part of this chapter is devoted to a description of clinical or human toxicity. 

Topiramate, cognitive reactions, 26.81 Topoisomerase inhibitors, 21 All Topotecan, 21 All Trocetrapib, 32.816 Transfusions AIDS, 12.298 complications, 12.300 Tretinoin, topical, teratogenicity, 18.164 Triazolam, 16.33 Tricyclic antidepressants endocrine reactions, 11.12 mania, 13.8... 

On the basis of these data and further in-house review, the FDA has classified topical tretinoin as Category C [71], implying at least one animal study has shown teratogenic effects at higher doses than used in humans and no studies in humans have shown a teratogenic effect or human studies have not been done. 

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