A recent analysis has brought to light a concerning trend among new drugs approved by the U.S. Food and Drug Administration (FDA).
Nearly one-third of these drugs, approved over a decade, were later found to have unexpected and sometimes life-threatening side effects or complications. This revelation raises questions about the thoroughness of drug testing before approval.
The Study: A Deep Dive
The analysis encompassed all 222 FDA-approved prescription drugs between 2001 and 2010. The researchers focused on potential problems that emerged during routine monitoring once the drugs were available to the public.
Among the 71 flagged drugs, many were top sellers for treating depression, arthritis, infections, and blood clots. The safety issues ranged from severe skin reactions and liver damage to cancer and, in some cases, death.
Dr. Joseph Ross, the study’s lead author and an associate professor of medicine and public health at Yale University, expressed surprise at the high percentage of problems, many of which were not observed during the review process.
The FDA’s Role: A Balancing Act
While the findings may doubt the FDA’s approval process, Dr. Ross suggests that the results indicate the FDA’s diligence in monitoring drugs post-approval.
He acknowledges that new safety concerns are bound to emerge when a drug is used in a broader population and commends the FDA for actively communicating these concerns.
The Hidden Dangers: Black-Box Warnings and Withdrawals
The study noted black-box warnings for dozens of drugs, indicating severe problems, including fatalities or life-threatening conditions linked to the drugs.
Additionally, there were alerts for less serious potential harms and three drug withdrawals due to the potential for death or other serious harm. Among the drugs with added warnings were
- Humira (used for arthritis),
- Abilify (used for depression and other mental illnesses)
- Pradaxa (a blood thinner)
The Nature of the Drugs: A Contributing Factor
The analysis revealed that safety issues were more common for psychiatric and biological drugs (derived from living cells) than traditional chemical-based drugs.
Drugs approved through an “accelerated” process were also slightly more likely to have later safety issues.
The Pressure to Accelerate: A Double-Edged Sword
In recent years, there has been mounting pressure on the FDA to expedite its regulatory review process to bring new drugs to the market sooner. However, this study raises concerns regarding the adequacy of testing new drugs before approval.
Thomas Moore, a senior scientist for drug safety and policy at the Institute for Safe Medication Practices, emphasizes the importance of extensive testing to ascertain the value and safety of new treatments.
Conclusion: A Call for Vigilance
As new drugs continue to enter the market, regulatory bodies, healthcare professionals, and patients must remain vigilant.
The commitment to post-market surveillance and thorough testing before approval is crucial in safeguarding public health and ensuring that medications serve their intended purpose without posing unforeseen risks.