Drug companies should disclose adverse events before licensing

October 14, 2004

Following the withdrawal of the painkiller and anti-inflammatory drug rofecoxib (Vioxx), researchers in this week's BMJ argue that patients would be safer if drug companies disclosed adverse events before licensing.

Single phase III drug trials are simply not big enough to detect relatively uncommon but important adverse events, which may affect large numbers of people in routine clinical use, writes Paul Dieppe and colleagues.

Furthermore, the impact of undetected adverse events is likely to be made worse if widely marketed new drugs are prescribed haphazardly and rapidly to large numbers of people. Within five months of the launch of rofecoxib, more than 42,000 patients had been prescribed the drug in England.

To prevent further similar 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, say the authors. This will allow independent, timely, and updated systematic reviews of serious adverse events.

They also suggest phased introduction of new drugs in independent, large-scale, randomised trials before licensing, together with better postmarketing 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 conclude.
-end-


BMJ

Related Drugs Articles from Brightsurf:

The danger of Z-drugs for dementia patients
Strong sleeping pills known as 'Z-drugs' are linked with an increased risk of falls, fractures and stroke among people with dementia, according to new research.

Wallflowers could lead to new drugs
Plant-derived chemicals called cardenolides - like digitoxin - have long been used to treat heart disease, and have shown potential as cancer therapies.

Bristol pioneers use of VR for designing new drugs
Researchers at the University of Bristol are pioneering the use of virtual reality (VR) as a tool to design the next generation of drug treatments.

Towards better anti-cancer drugs
The Bayreuth biochemist Dr. Claus-D. Kuhn and his research team have deciphered how the important human oncogene CDK8 is activated in cells of healthy individuals.

Separating drugs with MagLev
The composition of suspicious powders that may contain illicit drugs can be analyzed using a quick and simple method called magneto-Archimedes levitation (MagLev), according to a new study published in the journal Angewandte Chemie.

People are more likely to try drugs for the first time during the summer
American teenagers and adults are more likely to try illegal or recreational drugs for the first time in the summer, a new study shows.

Drugs used to enhance sexual experiences, especially in UK
Combining drugs with sex is common regardless of gender or sexual orientation, reveals new research by UCL and the Global Drug Survey into global trends of substance-linked sex.

Promising new drugs for old pathogen Mtb
UConn researchers are targeting a metabolic pathway, the dihydrofolate reductase pathway, crucial for amino acid synthesis to treat TB infections.

Can psychedelic drugs heal?
Many people think of psychedelics as relics from the hippie generation or something taken by ravers and music festival-goers, but they may one day be used to treat disorders ranging from social anxiety to depression, according to research presented at the annual convention of the American Psychological Association.

New uses for existing antiviral drugs
Broad-spectrum antiviral drugs work against a range of viral diseases, but developing them can be costly and time consuming.

Read More: Drugs News and Drugs Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.