With a view to preventing more of Rofecoxib-like episodes, experts have suggested that drug companies should disclose all the data on the adverse side effects before the drug is licensed.
"Single phase III drug trials are simply not big enough to detect relatively uncommon but important adverse events which may affect large number of people in routine clinical use," a team led by Paul Dieppe from the University of Bristol, United Kingdom, said.
"To prevent further episodes, drug companies should be legally required to make all data on serious adverse events from clinical studies available to the public immediately after completion of the research," they said.
There should be legal requirement for drug companies to register all randomised controlled trials, they said.
Rofecoxib, a widely used pain killer was recently banned as it was found to cause an increase in risk for heart diseases.
Besides, the impact of undetected adverse events is likely to be made worse if widely marketed new drugs are prescribed haphazardly and rapidly to large number of people, the scientists said in the British Medical Journal, adding that within five months of the launch of Rofecoxib, more than 42,000 patients had been prescribed the drug in England.
They also suggested phased introduction of new drugs in independent, large scale randomised trials before licensing, together with better post marketing surveillance.
"Although these measures will not be popular with pharmaceutical companies, they will limit the numbers of patients exposed to unknown hazards and provide robust and unbiased evidence on adverse events before a drug is fully licensed," they said.
© 2025