14th Signal Review Panel Meeting of Pharmacovigilance Programme of India (PvPI) held on 28th February

·         Amikacin-associated blurred vision: Signal Review Panel suggested PvPI to continue the close monitoring for amikacin associated blurred vision.

·         Ofloxacin-associated mouth ulcer: Signal Review Panel suggested PvPI to continue the close monitoring for ofloxacin associated mouth ulcer.

·         Bedaquiline-associated hypokalemia: Signal Review Panel suggested PvPI to continue the close monitoring and collect the baseline value of potassium prior initiation of treatment for all reported cases of bedaquiline-associated hypokalemia in PvPI database.

·         Clobazam-associated alopecia: SRP suggested PvPI to continue the close monitoring for clobazam-associated alopecia.

·         Telmisartan-associated lichenoid keratosis: SRP suggested PvPI to continue the close monitoring for telmisartan-associated lichenoid keratosis.

·         Tramadol-associated hiccups: PvPI to suggest CDSCO to take necessary steps to incorporate hiccups as an adverse drug reaction into the PIL of the tramadol marketed in India.

·         Phenobarbital-associated DRESS syndrome: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate DRESS syndrome as an adverse drug reaction into the PIL of the phenobarbital marketed in India.

·         Cefepime-associated urticaria: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate urticaria as an adverse drug reaction into the PIL of the cefepime marketed in India.

·         Glibenclamide-associated palpitation: The SRP recommended PvPI to suggest CDSCO to take necessary steps to incorporate palpitation as an adverse drug reaction into the PIL of the glibenclamide marketed in India.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA