Last Updated on January 3, 2024 by The Health Master
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 the following eleven drug formulations, mention newly identified adverse reactions in the package insert of the drugs:
- Ranitidine iv,
- Ceftriaxone,
- Azithromycin,
- Cloxacillin,
- Itraconazole,
- Ibuprofen,
- Amoxicillin/clavulanate,
- Ciprofloxacin,
- Dipeptidyl peptidase-4 (DPP4) inhibitors,
- Doxycycline,
- Tinidazole.
The DCGI issued the letters 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 on various adverse events based on recommendations from the Pharmacovigilance Program of India (PvPI):
- Ccardiac 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.
- Fixed drug eruption as an adverse event related to doxycycline and tinidazole.
The respective SEC suggested that the newly identified adverse events should be incorporated in the package insert of above said drugs which are approved by CDSCO and marketed in the country in various dosage forms.
The National Co-Ordination Center for PvPI, functioning under the Indian Pharmacopeia Commission (IPC), had forwarded their recommendation on adverse drug reaction reports on above medicinal products to CDSCO with the objective of detecting signal/prescribing information leaflet change from the Indian database and promoting 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 the 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 the PIL of ceftriaxone and AGEP as an ADR into the 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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