Nearly one third of new drugs approved by FDA have safety problems

[China Pharmaceutical network industry trends] on May 9, the Journal of the American Medical Association published research and disclosed that nearly one third of the new drugs approved by the US Food and Drug Administration had safety problems after they were put on the market The study was led by Yale University Although most of the safety problems are not serious enough to require drug withdrawal, the discovery also highlights the need for continuous monitoring of the safety of drugs after they have been on the market for many years (nearly one third of the new drugs approved by FDA have safety problems) at present, all drugs approved by FDA need to carry out clinical trials, but most of the trials recruit less than 1000 patients, and the tracking time is 6 months or less, sometimes no rare or long-term serious safety risks can be found To this end, Yale University associate professor Joseph rose and others launched an investigation on 222 new drugs approved by the FDA from January 2001 to December 2010 The results showed that 71 kinds of drugs had safety problems after they were put on the market, and 3 kinds of drugs were withdrawn from the market The drug administration also required some drugs to mark "black box warning" at the packaging and other places, and reported the drug safety problems to doctors and patients for many times The research also shows that new drugs with more safety problems after being put on the market include biological agents, psychoactive drugs, treatment drugs with accelerated approval and treatment drugs with approval close to the audit period However, rose stressed that their results do not indicate that the FDA is not doing a good job In fact, the FDA will still track the safety of drugs after they are put on the market In a statement, the FDA said it would monitor the safety of drugs on the market In general, they will not comment on specific studies, but will evaluate them to better protect public health.