7 FDA Approvals That Experts Say Should Have Never Happened
When the U.S. Food and Drug Administration gives its stamp of approval, the public expects that means safety, efficacy, and trust. But throughout history, several drugs and devices have slipped through the agency’s regulatory net, sometimes with devastating consequences. These controversial approvals have sparked lawsuits, ruined reputations, and fueled ongoing debates about how the system should work.
Critics argue that political pressure, corporate lobbying, and flawed clinical trials have all played roles in allowing risky products to reach American homes.
1. Vioxx: The Painkiller That Broke Hearts
Vioxx was once hailed as a miracle drug for arthritis sufferers seeking relief without the stomach issues caused by traditional painkillers. Approved in 1999, it quickly became one of the world’s top-selling drugs, generating billions for its manufacturer. But within a few years, studies linked Vioxx to a dramatically increased risk of heart attacks and strokes. Estimates suggest tens of thousands of deaths may have been tied to its use before it was pulled from the market in 2004. Many experts now argue that red flags in early trials should have stopped its approval in the first place.
2. Fen-Phen: The Diet Pill Duo That Devastated Hearts and Lungs
In the 1990s, millions chased quick weight loss through the wildly popular combination of fenfluramine and phentermine, known as Fen-Phen. This powerful duo promised dramatic results, but soon, reports of severe heart valve damage and deadly pulmonary hypertension emerged. Investigations revealed that evidence of these dangers had surfaced long before the public knew. The FDA eventually forced fenfluramine off the market in 1997, but not before thousands suffered irreversible harm. The fallout sparked one of the largest product liability settlements in history.
3. DES: A Disaster Passed Down Through Generations
Diethylstilbestrol, or DES, was approved in the 1940s as a synthetic estrogen prescribed to pregnant women to prevent miscarriages and complications. For decades, doctors gave it to millions without solid proof it worked, ignoring emerging evidence of serious risks. By the 1970s, it became clear that DES increased cancer risk not only for the women who took it but also for their children and even grandchildren. Entire families have grappled with infertility, birth defects, and rare cancers linked to this misguided approval. The legacy of DES remains one of the most haunting examples of generational harm caused by regulatory failure.
4. OxyContin: Fuel for an Opioid Crisis
When OxyContin hit the market in 1996, its manufacturer claimed its time-release formula made it less addictive than other opioids. The FDA approval helped unleash what would become one of the worst drug crises in American history. Aggressive marketing and misleading labeling downplayed the risk of dependency, leading doctors to prescribe it liberally for all types of pain. Years later, the country is still reeling from the devastation as overdose deaths continue to climb. Critics argue that better scrutiny of the company’s claims could have saved countless lives.
5. Thalidomide: A Tragedy Averted Too Late Abroad
Thalidomide is one of the most infamous drugs ever linked to birth defects, but few realize it nearly slipped through in the United States too. In the late 1950s, this sedative was widely prescribed in Europe and other countries to treat morning sickness, causing thousands of babies to be born with severe deformities. In the U.S., a single FDA reviewer resisted immense pressure and withheld approval, sparing the country the worst of the disaster. However, the drug was later re-approved decades later for other uses, and the risk of birth defects remains if not strictly controlled. Many experts still question whether any benefit is worth the nightmare that thalidomide’s name carries.
6. Darvocet: A Pain Reliever That Was Anything But Safe
Darvocet was marketed as a mild pain reliever for decades despite mounting evidence of its dangers. Approved in the 1950s, it became a staple for millions seeking relief from moderate pain. Over the years, data linked the drug to heart rhythm abnormalities and fatal overdoses, yet regulators failed to act swiftly. It wasn’t until 2010 that the FDA finally banned Darvocet and its active ingredient, propoxyphene, from the market. Many medical experts still wonder why it took over fifty years for such a clear hazard to be pulled.
7. Essure: The Birth Control Implant That Backfired
Essure was introduced as a groundbreaking non-surgical form of permanent birth control, marketed heavily to women seeking a quick and simple alternative to traditional sterilization. Approved by the FDA in 2002, it was inserted into the fallopian tubes to create scar tissue that blocked eggs from reaching the uterus. But thousands of women reported excruciating pain, organ perforations, and unintended pregnancies. Despite mounting complaints, Essure remained on the market for over fifteen years before its manufacturer voluntarily stopped sales in 2018. Many believe the approval process overlooked critical safety data that could have prevented years of suffering.
Lessons That Should Never Be Forgotten
Each of these approvals tells a story about what can go wrong when safety takes a back seat to speed, profit, or flawed evidence. The consequences ripple far beyond individual patients, shaking public trust in the very system designed to protect it. While the FDA has improved its oversight in some ways, these missteps remind the world that rigorous, unbiased scrutiny must never be compromised.
Policymakers, medical professionals, and patients alike have a stake in demanding better standards and more transparency. What do you think of the FDA and their oversight of the drugs in America?
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