Safety of dermatologic agents in pregnancy

S Pande, V Kharkar

 Department of Dermatology, KEM Hospital and Seth GS Medical College, Mumbai - 400012, India

Correspondence Address:
S Pande
Department of Dermatology, KEM Hospital and Seth GS Medical College, Mumbai - 400012
India

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 [Table - 1], [Table - 2] & [Table - 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.

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