A significant number of FDA drug approvals eventually face safety issues.
If you even pay minimal attention to pharmaceutical news, you know that the industry seems to be plagued with recalls and legal disputes. New data mirrors this. Reports indicate that around 1/3 of FDA drug approvals have safety issues. That’s right 1 and every 3 FDA drug approvals put the consumer at risk.
With increased pressure to to shorten the drug approval process, 19 drugs have received FDA-approval this year. That number is almost as many drug approvals as in the entirety of 2016.
After the drug approval the impacted drugs were subject to recalls, added warning labels, and safety advisories. From the Mylan EpiPen recall to the phantom Motrin recall, consumers were put at risk unbeknownst to themselves or the FDA, apparently.
This is troubling as patients put their confidence in these FDA drug approvals. Although most of the concerns were not risky enough to warrant a recall, in the time period reported only 3 drugs required being removed from the market.
An author of the study, Dr. Nicholas S. Downing, elaborated on the findings. He noted that drug approvals typically come after a trial on 1,000 patients, often times it is difficult when the product is put up against real-world factors.
A patient’s race, gender, ethnicity, weight, and previous medical conditions can all be factors for the way in which drugs impact them.
Experts assert that there is not reason for alarm, but that the new study is a good argument for continuous monitoring of the safety of drugs “throughout their life cycle.”