A new study is meant to remind us that most drugs can have side effects, even if they receive FDA approval. The results show that one in three such drugs comes with safety issues. After reaching the market, 33 percent of FDA-approved drugs cause subsequent problems.
The study, published in the JAMA journal, reminds us that not every pill approved by the US Food and Drug Administration is as safe as believed. Researchers gathered data from 2001 up until 2010. They found that 71 of the 220 new approved drugs caused around 123 postmarked safety problems.
Many FDA-approved drugs received additional warning labels
Some of these products had labels which did not state every possible side effect. Also, there was no mention that taking them could threaten the lives of people suffering from some other conditions. Therefore, in that period, the FDA added more than 61 boxed warnings. These signals, also known as black box warnings, are usually added to the original label of a drug when it is discovered it can be life-threatening.
Usually, drugs for mental illnesses come with a higher number of safety problems. The other FDA-approved medicine did not have severe side effects, but patients still needed to be warned about the product safety. Also, 3 out of 220 new drugs were withdrawn from the market. The most numerous safety issues appeared after an accelerated process of approval.
No drugs are 100 percent safe
This should make us think twice before regarding an FDA-approved drug as completely safe. However, people should not despair. For every person with a certain disease, there is a medicine that is both safe and efficient.
“The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug,” said lead author Dr. Nicholas S. Downing
The main problem with these FDA-approved drugs is that, most of the times, the human trials are small. They are usually tested on 1,000 people or even fewer before they receive approval. This explains why, when administered to a wider population, safety problems tend to appear. 1,000 people are too few to demonstrate the drug is both safe and efficient.
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