The number of reported serious adverse events from drug treatment more than doubled in the United States from 1998 to 2005, rising from 34,966 to 89,842.
Over the same period the number of deaths relating to drugs nearly tripled, from 5519 to 15 107, show data from the US Food and Drug Administration's adverse event reporting system, which collects all reports of adverse events submitted voluntarily to the agency either directly or through drug manufacturers.
Source: Archives of Internal Medicine 2007;167:1752-9.
BMJ 2007;335:585 (22 September), doi:10.1136/bmj.39339.624711.DB
http://www.bmj.com/cgi/content/extract/335/7620/585-a
Showing posts with label Pharmacovigilance. Show all posts
Showing posts with label Pharmacovigilance. Show all posts
Saturday, September 22, 2007
Wednesday, August 29, 2007
Indian Drug Regulator to get serious about Pharmacovigilance
The Indian drug regulator is planning a major overhaul in the country’s drug adverse reaction monitoring system.
The Central Drugs Standard Control Organisation is now planning to appoint a team of about 100 clinical pharmacologists across the country, on a contract basis, to collect adverse drug reaction reports and patient complaints from hospitals, clinics and practising clinicians.
“We are not taking any chances now, because the domestic pharma market is growing and a host of new drugs are being launched by domestic as well as foreign companies,” said M. Venkateswarlu, India’s drug controller general. “Though the new drugs are approved after verifying the clinical trial data, this will not be enough to establish the absolute safety of a drug as these are conducted in limited number of volunteers or patients, which are only indicative. So a regular post-marketing study will only provide the actual response (effects and side effects) of the drug as it has been practically used in a wider patient pool.”
Though it is the responsibility of drug manufacturers to do these studies on newly marketed drugs and submit the data to the regulator, the system has been a failure in India as most companies flout the law.
As a result, the country had hardly any drug recalls, even though several drugs marketed here are alleged to have a doubtful safety profile. The system could also be an early-warning system unlike recent cases, including recall controversies over GlaxoSmithKline Plc.’s Avandia diabetes drug and the voluntary recall of cardiac stents by Johnson & Johnson, where Indian authorities are still seeking information from their Western counterparts and the multinational drug companies.
Source and detailed report: http://www.livemint.com/2007/08/27004814/Drug-regulator-to-monitor-side.html
The Central Drugs Standard Control Organisation is now planning to appoint a team of about 100 clinical pharmacologists across the country, on a contract basis, to collect adverse drug reaction reports and patient complaints from hospitals, clinics and practising clinicians.
“We are not taking any chances now, because the domestic pharma market is growing and a host of new drugs are being launched by domestic as well as foreign companies,” said M. Venkateswarlu, India’s drug controller general. “Though the new drugs are approved after verifying the clinical trial data, this will not be enough to establish the absolute safety of a drug as these are conducted in limited number of volunteers or patients, which are only indicative. So a regular post-marketing study will only provide the actual response (effects and side effects) of the drug as it has been practically used in a wider patient pool.”
Though it is the responsibility of drug manufacturers to do these studies on newly marketed drugs and submit the data to the regulator, the system has been a failure in India as most companies flout the law.
As a result, the country had hardly any drug recalls, even though several drugs marketed here are alleged to have a doubtful safety profile. The system could also be an early-warning system unlike recent cases, including recall controversies over GlaxoSmithKline Plc.’s Avandia diabetes drug and the voluntary recall of cardiac stents by Johnson & Johnson, where Indian authorities are still seeking information from their Western counterparts and the multinational drug companies.
Source and detailed report: http://www.livemint.com/2007/08/27004814/Drug-regulator-to-monitor-side.html
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