It is with interest that we see the dark cloud of concern looming
over yet another popularly used drug (1). It is also very interesting that
the concern should be raised after Valsartan has recently gained a licence
to be used post myocardial infarction.
Doctors seem keen to use newly licensed drugs to help their patients
however the current licensing system appears to be failing to protect
patients from severe rarer adverse drug reactions and also drug companies
from potential litigation costs.
At present a drug can gain a licence after it has been used by as few as
2,500 patients at which stage an adverse reactions with a frequency of
less that 1/1000 are unlikely to be identified and as in the case of
rofecoxib the reaction may be only identified after it has been used for a
period of time.
To prevent further concerns it appears that the present licensing system
should be changed. It would be prudent to provide new drugs with a
provisional licence and the drug monitored for a further 2 years before
being granted a full licence. It would be in the interest of the drug
company to fund an independent body to monitor spontaneous reports from
the UK and around the world, analyse drug trials and use other post
marketing surveillance systems to provide the MHRA and the company with
six monthly reports. During this period it would be mandatory for the
prescribers to report any adverse drug reactions.
1. Verma S Strauss M Angiotensin receptor blockers and myocardial
infarction BMJ 2004; 329: 1248-1249
Rapid Response:
Drug monitoring
Dear Sir
It is with interest that we see the dark cloud of concern looming
over yet another popularly used drug (1). It is also very interesting that
the concern should be raised after Valsartan has recently gained a licence
to be used post myocardial infarction.
Doctors seem keen to use newly licensed drugs to help their patients
however the current licensing system appears to be failing to protect
patients from severe rarer adverse drug reactions and also drug companies
from potential litigation costs.
At present a drug can gain a licence after it has been used by as few as
2,500 patients at which stage an adverse reactions with a frequency of
less that 1/1000 are unlikely to be identified and as in the case of
rofecoxib the reaction may be only identified after it has been used for a
period of time.
To prevent further concerns it appears that the present licensing system
should be changed. It would be prudent to provide new drugs with a
provisional licence and the drug monitored for a further 2 years before
being granted a full licence. It would be in the interest of the drug
company to fund an independent body to monitor spontaneous reports from
the UK and around the world, analyse drug trials and use other post
marketing surveillance systems to provide the MHRA and the company with
six monthly reports. During this period it would be mandatory for the
prescribers to report any adverse drug reactions.
1. Verma S Strauss M Angiotensin receptor blockers and myocardial
infarction BMJ 2004; 329: 1248-1249
Competing interests:
None declared
Competing interests: No competing interests