|
IPC recommends caution on 3 life saving drugs in market to CDSCO based on ADRs
|
|
Suja Nair Shirodkar
July 23 , 2015
|
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|