DCGI directs state DCs to ask manufacturers of 7 drugs to incorporate newly identified ADRs in package insert of drugs
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 and acute generalized exanthematous pustulosis as an adverse event related to cefixime formulations based on recommendations of Pharmacovigilance Programme of India (PvPI).
The respective SEC suggested that the newly identified adverse events should be incorporated in the package insert of cefotaxime, ofloxacin, tranexamic acid, quetiapine, sulfasalazine, sodium valproate and cefixime which are approved by CDSCO and marketed in the country in various dosage forms.
The National Co-Ordination Centre for PvPI, functioning at Indian Pharmacopoeia Commission (IPC) had forwarded their recommendation on adverse drug reaction reports on above medicinal products to CDSCO following discussion at the 13th Signal Review Panel meeting on August 21, 2018.
In the meeting, the PvPI had evaluated ADRs associated with the seven drugs on the basis of individual case study reports (CSR) and recommended CDSCO to take necessary steps to incorporate angioedema as an ADR into the prescribing information leaflet (PIL) of cefotaxime marketed in the country and include Stevens Johnson Syndrome/toxic epidermal necrolysis (TEN) as an ADR into PIL of ofloxacin and seizure as an ADR into PIL of tranexamic acid.
It also suggested CDSCO to ensure that urinary incontinence gets mentioned as an ADR into PIL of quetiapine. It further said the PIL of sulfasalazine should incorporate DRESS Syndrome as an ADR of the drug. The PIL of sodium valproate should mention gum hyperplasia as an ADR of the drug and acute generalized exanthematous pustulosis should be incorporated as an ADR in PIL of cefixime formulations, said PvPI in its recommendation to CDSCO.
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 and acute generalized exanthematous pustulosis as an adverse event related to cefixime formulations based on recommendations of Pharmacovigilance Programme of India (PvPI).
The respective SEC suggested that the newly identified adverse events should be incorporated in the package insert of cefotaxime, ofloxacin, tranexamic acid, quetiapine, sulfasalazine, sodium valproate and cefixime which are approved by CDSCO and marketed in the country in various dosage forms.
The National Co-Ordination Centre for PvPI, functioning at Indian Pharmacopoeia Commission (IPC) had forwarded their recommendation on adverse drug reaction reports on above medicinal products to CDSCO following discussion at the 13th Signal Review Panel meeting on August 21, 2018.
In the meeting, the PvPI had evaluated ADRs associated with the seven drugs on the basis of individual case study reports (CSR) and recommended CDSCO to take necessary steps to incorporate angioedema as an ADR into the prescribing information leaflet (PIL) of cefotaxime marketed in the country and include Stevens Johnson Syndrome/toxic epidermal necrolysis (TEN) as an ADR into PIL of ofloxacin and seizure as an ADR into PIL of tranexamic acid.
It also suggested CDSCO to ensure that urinary incontinence gets mentioned as an ADR into PIL of quetiapine. It further said the PIL of sulfasalazine should incorporate DRESS Syndrome as an ADR of the drug. The PIL of sodium valproate should mention gum hyperplasia as an ADR of the drug and acute generalized exanthematous pustulosis should be incorporated as an ADR in PIL of cefixime formulations, said PvPI in its recommendation to CDSCO.
Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=115187&sid=1
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