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DCGI directs state DCs to ask manufacturers of 11 drugs to incorporate newly identified ADRs in their package insert
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Laxmi Yadav, Mumbai
February 09 , 2022
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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 eleven drug formulations— ranitidine iv, ceftriaxone, azithromycin, cloxacillin, itraconazole, ibuprofen, amoxicillin/clavulanate, ciprofloxacin, dipeptidyl peptidase-4 (DPP4) inhibitors, doxycycline and tinidazole -- mention newly identified adverse reactions in the package insert of the drugs.
The DCGI issued the direction to state DCs on February 4, 2022 based on recommendations of the subject expert committee (SEC) of the respective therapeutic area.
The respective SEC had deliberated cardiac arrest as an adverse reaction to ranitidine IV, Stevens Johnson Syndrome (SLS) as an adverse event of Ceftriaxone, acute generalized exanthematous pustulosis (AGEP) as an adverse reaction related to azithromycin and cloxacillin, photosensitivity as an adverse reaction to itraconazole, Stevens Johnson Syndrome/toxic epidermal necrolysis (TEN) as adverse reaction related to ibuprofen, amoxicillin/clavulanate and ciprofloxacin, arthralgia as an adverse event involving dipeptidyl peptidase-4 (DPP4) inhibitors like sitagliptin, vildagliptin, saxagliptin etc. and fixed drug eruption as an adverse event related to doxycycline and tinidazole 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 ranitidine IV, ceftriaxone, azithromycin, cloxacillin, itraconazole, ibuprofen, amoxicillin/clavulanate, ciprofloxacin, dipeptidyl peptidase-4 (DPP4) inhibitors, doxycycline and tinidazole 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 with an objective to detect signal/prescribing information leaflet change from Indian database and promote patient safety.
The PvPI had evaluated ADRs associated with the eleven drugs on the basis of individual case study reports (CSR) and recommended CDSCO to take necessary steps to incorporate cardiac arrest as an ADR into the prescribing information leaflet (PIL) of ranitidine IV marketed in the country and include Stevens Johnson Syndrome (SLS) as an ADR into PIL of ceftriaxone and AGEP as an ADR into PIL of azithromycin and cloxacillin.
It also suggested CDSCO to ensure that photosensitivity gets mentioned as an ADR into PIL of itraconazole. It further said the PIL of ibuprofen, amoxicillin/clavulanate and ciprofloxacin should incorporate SLS/ toxic epidermal necrolysis (TEN) as an ADR of the drug.
The PIL of dipeptidyl peptidase-4 (DPP4) inhibitors like sitagliptin, vildagliptin, saxagliptin etc, should mention arthralgia as an ADR of the drug and fixed drug eruption should be incorporated as an ADR in PIL of doxycycline and tinidazole formulations, said PvPI in its recommendation to CDSCO.
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