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A drug used to treat acne in women may cause severe birth defects, the Central Drugs Standard Control Organisation (CDSCO) warned the States.
The CDSCO has re-issued safety guidelines regarding the use of the oral drug, Isotretinoin, used for the treatment of severe nodular acne which does not respond to antibiotics.
The CDSCO, in a letter to all the State and Union Territories’ drugs controllers on Wednesday, reiterated that all packs of Isotretinoin should carry a warning that the medicine can cause severe birth defects. It also warned that the medicine should not be taken by a woman who is pregnant or likely to get pregnant.
“You should also avoid pregnancy for 6 months after stopping the treatment,” the warning states. Isotretinoin capsules of 10 and 20 mg were approved by the CDSCO in June 2002 with a requirement of a box warning.
However, in the light of concerns raised with regard to the safety of the drug, the matter was examined by the CDSCO in consultation with the Subject Expert Committee (SEC) for Dermatology and Allergy, on July 26. “The SEC deliberated on the matter and opined that the drug has favourable risk/benefit profile for the indications approved in the country,” the letter said.
The CDSCO said that the drug should be sold only on the prescription of a dermatologist.
It also instructed that the patients should sign a consent form before undertaking the treatment.
The CDSCO has asked all the State-level officials to ask manufacturers, retailers and wholesale distributors to comply with the norms.
“The committee also recommended that the manufacturers should provide a package insert along with their product in major local languages. The retail chemists should maintain the details of retail sale of the drug,” the letter stated.
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