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Controversies Surrounding Drug Safety Post-FDA Clearance

Concerns about the Safety of Drugs Post-FDA Approval

Issues Concerning Safety of Drugs Post-Approval by FDA
Issues Concerning Safety of Drugs Post-Approval by FDA

Controversies Surrounding Drug Safety Post-FDA Clearance

In a pioneering study published last week in the Journal of the American Medical Association (JAMA), researchers led by Yale have discovered that safety issues are identified in nearly a third of drugs after they receive approval from the Food and Drug Administration (FDA). The study, building upon earlier work by the same team, underscores the importance of continuous monitoring and testing of drugs, even those that have been in the marketplace for decades. Dr. Nicholas Downing, the first author of the research paper, stresses that we don't know if a drug will be as safe or effective as the FDA thought it would be based on premarket clinical evidence. The FDA's drug approval process involves a delicate balance of clinical benefit against potential adverse events. The new findings highlight that FDA approval does not mean that everything about a drug is known. As drugs are used for longer periods of time and in broader populations, new information can be learned. Downing uses aspirin as an example, a drug that is still the subject of ongoing clinical trials today, indicating the need for continuous learning about drugs even after they have been widely used for many years. The study found that approximately 4.2 years after approval, post-market safety events are typically detected in 1 out of 3 drugs. Both Downing and Patrick, PharmD, from The Ohio State University Comprehensive Cancer Center, find the rate of 32% post-market safety events to be relatively low. However, Downing wonders if there are methods to identify drugs with potential safety issues sooner, minimizing the number of people exposed and the time spent on a new drug before a safety event is discovered. Downing also emphasizes that different patients can respond differently to the same drug due to factors like genetic profile, disease severity, etc. Therefore, a one-size-fits-all approach when treating patients with drugs is not feasible. The FDA's continued monitoring of drugs after approval is seen as evidence of its commitment to ensuring drug safety throughout their entire life cycle. The researchers emphasize that once the drugs are made available to larger numbers of people, issues will invariably pop up. The findings of this study underscore the importance of ongoing research and monitoring to ensure the safety and effectiveness of the drugs we use.

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