This is demonstrated by research published in Jama: from 2001 to 2010, 71 out of 222 therapies presented problems associated with safety only after being placed on the market. Biological, psychiatric drugs and those subjected to accelerated courses among the most subject
Of Cristina Tognaccini – May 12, 2017 – Aboutpharma
A third of drugs approved by the Food and Drug Administration (FDA) have been associated with a safety risk, which only emerged after the product was placed on the market. The data, disclosed by an article published in Jama, points out that many adverse events associated with new products only occur when they are used in daily clinical practice in a real, uncontrolled population.
From 2001 to 2010, the period taken into consideration by American researchers, the FDA approved 222 new therapies: 183 pharmacological products and 39 biological. Of these, 71 (32.0%) were characterized by a post-marketing safety event. The median time from therapy approval to the first postmarketing safety event was 4.2 years. The categories statistically most associated with these events were those of biological and psychiatric drugs, those subjected to accelerated approval procedures and those with approval within the regulatory deadlines. A fact that highlights how any new product must be continuously monitored throughout its life cycle.
"If we want faster review and approval times for new drugs, we also need to have an effective post-marketing monitoring system in place," said Joseph Ross, lead author of the paper and associate professor of medicine and public health at the University of Washington. Yale – and be able to promptly and appropriately communicate new security issues that may arise. No drug is completely safe and during the pre-marketing phase we are unable to detect all possible problems that may arise." According to the research, many studies in the United States are conducted in small populations involving approximately 1,000 participants who are followed for six months or so. And many problems only arise years later, when the drug has been used by a larger population for longer.
Related news: Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010
