Indian Journal of Dermatology, Venereology and Leprology
Medknow Publications on behalf of The Indian Association of Dermatologists, Venereologists and Leprologists (IADVL)
ISSN: 0378-6323
Vol. 69, Num. 5, 2003, pp. 355-356
Untitled Document

Indian Journal of Dermatology, Venerelogy & Leprology, Vol 69, No. 5 ,Sept-Oct, 2003, pp. 355-356


Safety of dermatologic agents in pregnancy

Compiled by: Sushil Pande, Vidya Kharkar

Department of Dermatology, KEM Hospital and Seth GS Medical College, Mumbai - 400012, India.
Address for correspondence: Dr. Sushil Pande, Department of Dermatology, KEM Hospital and Seth GS Medical College, Parel, Mumbai - 400012, India. E-mail:

Code Number: dv03060

Dermatologists need to be the familiar with the potential of medications to cause harm to the fetus or the mother. Moreover, safer alternatives are preferable in a woman of childbearing age, even if not pregnant.

The classification system indicating the level of safety of a particular drug during pregnancy was introduced by the US FDA.1 All drugs are classified into the following categories:1

A) "Controlled studies show no risk. Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to fetus".

B) "No evidence of risk in humans. Either animal findings show risk, but human findings do not; or, if no adequate human studies have been done, animal findings are negative".

C) "Risk cannot be ruled out. Human studies are lacking the animal studies are either positive for fetal risk or lacking as well. However, potential benefits may justify the potential risk".

D) "Positive evidence for risk. Investigational or post-marketing data show risk to fetus. Nevertheless, potential benefits may outweigh the potential risk".

X) "Contraindicated in pregnancy. Studies in animals or humans, or investigational or post-marketing reports, have shown fetal risk which clearly overweighs any possible benefit to the patient".

The following tables (Tables 1,2,3) enumerate the FDA category of the drugs commonly prescribed by dermatologists.

While the list of drugs appears exhaustive, it is still far from complete. Moreover, adequate data is not available about the safety of many drugs.

Drugs which are absolutely contraindicated, including those agents in risk category X, should be strictly avoided. Occasionally, it may be necessary to treat a woman during pregnancy or lactation with a category C drug after weighing the pros and cons of both options and discussing them with the patient. Rarely, limited use for drugs even in category D under close supervision may be necessary.5 Non-prescription drugs should also be avoided as far as possible.


  1. Sannerstedt R, Lundborg P, Danielsson BR, et al. Drugs during pregnancy: an issue of classification and information to prescribers. Drug Saf 1996;14:69-77.
  2. Hale EK, Pomeranz MK. Dermatologic agents during pregnancy and lactation: an update and clinical review. Int J Dermatol 2002;41:197-203.
  3. Mutalik N, Salvi V. Drugs in pregnancy. In: Salvi V, editor. Medical and surgical disorders in pregnancy, Mumbai: Jaypee Brothers Medical Publishers; 2003. p. 337-413.
  4. Drugs in pregnancy and breastfeeding, Created:11/17/2000 Last update: 11/30/2002 Last accessed: 20/12/2003.
  5. Physician Desk References. 57th ed. Montwale NJ: Thomson PDR; 2003. p. 3054.
  6. Kacew S. Fetal consequences and risks attributed to the use of prescribed and over-the-counter (OTC) preparations during pregnancy. Int J Clin Pharmacol Ther 1994;32:335-43.

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