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.

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