In a bid to promote patient safety, the Drugs Controller General of India (DCGI) has directed all state drug controllers in the country to take steps to ensure that manufacturers of seven formulations-- cefotaxime, ofloxacin, tranexamic acid, quetiapine, sulfasalazine, sodium valproate and cefixime-- mention newly identified adverse reactions in the package insert of the drugs. The DCGI issued the direction to state DCs on April 9, 2019 based on recommendations of subject expert committee (SEC) of the respective therapeutic area. At a meet held in January this year, the respective SEC had deliberated angioedema as an adverse reaction to cefotaxime, Stevens Johnson Syndrome/toxic epidermal necrolysis (TEN) as an adverse event of ofloxacin, seizure as an adverse reaction related to tranexamic acid, urinary incontinence as an adverse reaction to quetiapine, DRESS Syndrome as adverse reaction related to sulfasalazine, gum hyperplasia as an adverse event involving sodium valproate an...
