Its surprising but true, some medication, once approved, are pulled from the market due to serious adverse effect revealed only after widespread use.
I think we can fix it through:
Expand sample size and diversity
Longer follow-up period
By periodic re-evaluation
we need smarter systems that evolve with science. A truly safe and effective drug approval process is one that does not end at approval. It listens, learns, and adapts just like medicine itself.
Some drugs are withdrawn after approval due to unforeseen adverse effects or safety concerns that emerge post-marketing. While clinical trials identify many risks, they involve limited participants and controlled settings. Once a drug is widely used, rare side effects, long-term harms, or interactions may appear. Issues like liver toxicity, cardiovascular events, or increased mortality can prompt reevaluation. Additionally, problems with manufacturing, contamination, or misuse can lead to withdrawal. Regulatory bodies like the FDA monitor such cases through pharmacovigilance systems. If risks outweigh benefits, the drug is withdrawn to protect public health and ensure ongoing patient safety.
Yes need to change in drug approval system because once the drug is market then due to its toxicity calling back is risky and time consuming so its better to implement strict protocol
It’s honestly many drugs pass all trial phases and still get withdrawn later. Clinical trials are controlled and done on limited participants, so it’s hard to catch every possible side effect. But once a drug hits the real world—with different ages, health conditions, and combinations of medicines—unexpected issues come up.That’s why pharmacovigilance is so important. Instead of just stricter trial protocols, I think we need a stronger focus on post-marketing monitoring, faster reporting systems, and more public awareness. Because real-world data often tells a different story than trial data.The drug approval system should never stop at approval—it should evolve with time, just like our understanding of the drug does.
With clinical trial being done in a limited population, the data we would receive from the first three phases would also be limited. But once the drug hits the real world market, post marketing surveillance is the actual phase which determine how the drug actually works with the general public. A new adverse drug reaction, or a drug- drug interaction, drug- food interaction, formulation or dosage inconsistencies, anything could be identified once the drug enters the real market. Post marketing strategies should be improved by implementing better pharmacovigilance activities like proper follow-up, encouraging spontaneous reporting, case assessments, both by the pharmaceutical companies and the regulatory authorities.
While stricter clinical trial protocols can improve drug safety by identifying issues before approval, they have limitations, such as higher costs, longer timelines, and still missing rare or long-term side effects. Therefore, rather than relying solely on pre-approval trials, regulatory bodies should enhance post-marketing surveillance. Stronger real-world monitoring, better reporting systems, and quicker response mechanisms can more effectively detect and manage risks once a drug is in widespread use. A balanced approach combining both measures is essential for safer drug regulation.
I think the regulatory authorities are doing a decent job. We don’t see a lot of drugs being withdrawn from the market these days, and that says how careful the approval process already is.
But at the same time, some side effects just take longer to show up, especially the rare or longterm ones and that cannot be identified in trials right away.
In real life, people take all kinds of medications at once without even realizing how they might interact. So, I don’t think the issue is that trials aren’t strict enough, it’s more that real world use is just too unpredictable.
When the drug that came into market affecting many people with severe side effects.Then that drug will be withdrawn.As it passes all the clinical trials yet some drugs show the side effects after certain period…
Stricter trials help, but they can’t predict every real world outcome. We need stronger post marketing surveillance to catch rare or long-term side effects. A balanced approach is key to safer drug use.
No process is perfect. It’s essential for us to draw lessons from past discrepancies and continuously refine our processes. Regulatory agencies must stay nimble and ready to adapt to the ever-evolving landscape.