IPC recommends caution on 3 life saving drugs in market to CDSCO based on ADRs
Indian Pharmacopeia Commission’s (IPCs) signal review panel recently submitted strategic recommendation to the Central Drugs Standard Control Organisation (CDSCO) on the 3 important life saving drugs running in the market. These reports were submitted based on the detailed observation made by the expert panel following the adverse drug reaction (ADR) report generated from different ADR centres across the country.
Based on the evaluation report received from different AMCs under the Pharmacovigilance Programme of India (PvPI), it was found that use of carbamazepine is associated to cause Stevens Johnson Syndrome (SJS) in some patients. Dr V Kalaiselvan, principal scientific officer from the Indian Pharmacopoeia Commission informed that considering the safety of the patients, the review panel recommended the CDSCO to direct all the manufacturers to insert a clear warning on its label on the possible side effects of the drug, to caution the patients.
It is understood that carbamazepine which is available in different brands like Carbatrol, Epitol, Equetro, TEGretol, TEGretol XR etc. is a commonly prescribed anticonvulsant drug for epilepsy, which works by decreasing nerve impulses that cause seizures and pain. It is also used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy along with treating bipolar disorder.
Dr Kalaiselvan further stated that this report has been submitted after extensively analysing and studying ADR reports generated from more than 100 ADR centres across the country. SJS is a clinical syndrome presumed to be a hypersensitivity reaction manifested initially with prodromal symptoms of fever, malaise and a sore throat. The prodromal phase is then followed in some days by an acute polymorphous dermatologic syndrome manifested as erythematous maculo-papular like lesions, target lesions, bullae, vesicles, involvement of at least two mucous membranes, conjunctivitis and an associated systemic toxic state.
“Considering the seriousness of this matter, the panel has suggested the DCGI to take the above requisite steps for public safety. Apart from carbamazepine, IPC has also submitted recommendation to the Centre on two anti cancer drugs sunitinib and pazopanib as well. Based on the panels observation it has recommended the CDSCO to closely monitor these two drugs as there have been several incidents of ADRs reported from the use of these drugs,” he stressed.
Sunitinib is used to treat gastrointestinal stromal tumours (GIST) that grows in the stomach, intestine (bowel), or esophagus tube that connects the throat with the stomach in people with tumours that were not treated successfully with imatinib or people who cannot take imatinib. It is also used to treat advanced renal cell carcinoma (RCC), a type of cancer that begins in the cells of the kidneys and treat pancreatic neuroendocrine tumours (pNET), a type of tumour that begins in certain cells of the pancreas in people with tumours that have worsened and cannot be treated with surgery.
While pazopanib is used to treat advanced RCC in adults, it works by slowing or stopping the spread of cancer cells.
These observations were made based on report collected from over 60 ADR centres across the country. Signal detection in pharmacovigilance comprises of selection of drug adverse reaction, preliminary assessment of available evidence and a follow up on how the signal develops.
Indian Pharmacopeia Commission’s (IPCs) signal review panel recently submitted strategic recommendation to the Central Drugs Standard Control Organisation (CDSCO) on the 3 important life saving drugs running in the market. These reports were submitted based on the detailed observation made by the expert panel following the adverse drug reaction (ADR) report generated from different ADR centres across the country.
Based on the evaluation report received from different AMCs under the Pharmacovigilance Programme of India (PvPI), it was found that use of carbamazepine is associated to cause Stevens Johnson Syndrome (SJS) in some patients. Dr V Kalaiselvan, principal scientific officer from the Indian Pharmacopoeia Commission informed that considering the safety of the patients, the review panel recommended the CDSCO to direct all the manufacturers to insert a clear warning on its label on the possible side effects of the drug, to caution the patients.
It is understood that carbamazepine which is available in different brands like Carbatrol, Epitol, Equetro, TEGretol, TEGretol XR etc. is a commonly prescribed anticonvulsant drug for epilepsy, which works by decreasing nerve impulses that cause seizures and pain. It is also used to treat seizures and nerve pain such as trigeminal neuralgia and diabetic neuropathy along with treating bipolar disorder.
Dr Kalaiselvan further stated that this report has been submitted after extensively analysing and studying ADR reports generated from more than 100 ADR centres across the country. SJS is a clinical syndrome presumed to be a hypersensitivity reaction manifested initially with prodromal symptoms of fever, malaise and a sore throat. The prodromal phase is then followed in some days by an acute polymorphous dermatologic syndrome manifested as erythematous maculo-papular like lesions, target lesions, bullae, vesicles, involvement of at least two mucous membranes, conjunctivitis and an associated systemic toxic state.
“Considering the seriousness of this matter, the panel has suggested the DCGI to take the above requisite steps for public safety. Apart from carbamazepine, IPC has also submitted recommendation to the Centre on two anti cancer drugs sunitinib and pazopanib as well. Based on the panels observation it has recommended the CDSCO to closely monitor these two drugs as there have been several incidents of ADRs reported from the use of these drugs,” he stressed.
Sunitinib is used to treat gastrointestinal stromal tumours (GIST) that grows in the stomach, intestine (bowel), or esophagus tube that connects the throat with the stomach in people with tumours that were not treated successfully with imatinib or people who cannot take imatinib. It is also used to treat advanced renal cell carcinoma (RCC), a type of cancer that begins in the cells of the kidneys and treat pancreatic neuroendocrine tumours (pNET), a type of tumour that begins in certain cells of the pancreas in people with tumours that have worsened and cannot be treated with surgery.
While pazopanib is used to treat advanced RCC in adults, it works by slowing or stopping the spread of cancer cells.
These observations were made based on report collected from over 60 ADR centres across the country. Signal detection in pharmacovigilance comprises of selection of drug adverse reaction, preliminary assessment of available evidence and a follow up on how the signal develops.
