What is the outcome if a drug’s safety profile deteriorates post-approval?

If a drug's safety profile deteriorates after it has already received approval, the most significant outcome could indeed be that it is withdrawn from the market. This occurs when new evidence emerges indicating that the risks associated with the drug outweigh its benefits, which can happen due to reports of serious adverse effects or increased rates of incidents that were not observed during clinical trials.

The process to withdraw a medication involves evaluating the evidence surrounding its safety and potentially issuing a recall or a market withdrawal to protect public health. This action emphasizes the regulatory responsibility of ensuring that approved medications remain safe for consumer use.

While increased monitoring by the FDA is a common response to safety concerns, merely keeping a drug on the market without addressing the safety profile can pose risks to patients. Similarly, reclassifying a drug as over-the-counter is not typically an action taken solely due to post-approval safety concerns; this generally involves a different evaluation of the drug's safety and efficacy and assumes that the drug can be used safely without a prescription. A review without further action does not adequately address serious safety issues that would warrant a more proactive response.