Drug Withdrawals and Recalls: Why Medications Get Removed from Market

When a drug is pulled from the market, it’s not just a corporate decision-it’s a safety alarm. Millions of people rely on prescription medications, and when one gets withdrawn, it often means something went terribly wrong after approval. The FDA doesn’t remove drugs lightly. But when it does, it’s usually because the risks outweigh the benefits-or worse, the drug never worked the way it was supposed to.

Why Do Drugs Get Withdrawn?

Most drug withdrawals happen because of safety problems. About 60% of removals are due to unexpected side effects that only show up after thousands or even millions of people have taken the drug. These aren’t always obvious in clinical trials, which typically involve a few thousand patients over months. Real-world use reveals rare but dangerous reactions-like liver failure, heart rhythm issues, or severe allergic responses-that weren’t caught before approval.

The other major reason is lack of effectiveness. This is especially common with drugs approved under the FDA’s accelerated approval pathway. These drugs are fast-tracked based on early signs of benefit-like shrinking tumors-rather than proof they actually help patients live longer or feel better. Once confirmatory studies finish, many of these drugs fail to deliver on their promise. In oncology alone, about 26% of drugs approved through this route are later withdrawn because they didn’t improve survival.

Take Makena, a drug approved in 2011 to prevent preterm birth in high-risk women. It was based on a small, outdated study. By 2020, a large, rigorous trial showed it had no benefit. But the FDA didn’t pull it until 2022-over four years after the evidence was clear. During that time, an estimated 150,000 women received a drug that didn’t work.

The Old System Was Broken

Before 2023, the FDA had no real timeline for withdrawing drugs. Once a drug was approved, even if later studies proved it ineffective, the agency had to go through a slow, bureaucratic process. On average, it took 46 months-nearly four years-to remove a failed drug. Meanwhile, patients kept getting prescriptions.

In one study, 41% of eligible patients with small cell lung cancer were still being treated with a drug that had been proven ineffective. Doctors didn’t always know it had been flagged for withdrawal. Pharmacies kept filling the script. Insurance kept paying for it. The system had no built-in urgency.

The FDA’s own data showed that withdrawal notices often didn’t even include clear instructions for doctors on how to switch patients to safer alternatives. A 2023 audit found only 42% of notices included transition guidance. That’s not just a gap-it’s a risk.

The 2023 Fix: Faster, Clearer, Fairer

The Consolidated Appropriations Act of 2023 changed everything. For the first time, the FDA got a clear, structured path to remove drugs quickly when they fail to deliver. Under the new rules, the agency can move to withdraw a drug if:

• The manufacturer doesn’t do the required follow-up studies
• The confirmatory study proves the drug doesn’t work
• Independent data shows it’s unsafe or ineffective
• The company lied or misled doctors about the drug’s benefits

The process now includes mandatory steps: the FDA must notify the company, give them a chance to respond, allow public comment, and hold advisory meetings if needed. But there’s a hard deadline: the agency must make a final decision within 180 days of starting the process.

This isn’t just about speed-it’s about fairness. Companies can now appeal decisions and argue their case publicly. The old system was opaque. The new one is transparent.

How It Works in Practice

The first drug pulled under the new rules was an ALS treatment in August 2023. The FDA moved quickly because the company hadn’t submitted its required post-approval study. Within months, the drug was off the market.

The FDA created a dedicated team of 12 scientists and doctors to handle these cases. Their goal? Cut the average withdrawal time from 46 months to under 12 months. They’re already making progress. In 2024, the agency issued its first withdrawal notice based on real-world data from Flatiron Health-a major shift toward using actual patient outcomes, not just trial results.

For doctors, this means more clarity. The FDA now publishes detailed “Determination of Safety or Effectiveness” notices in the Federal Register. These aren’t just legal notices-they’re practical guides. They explain why the drug was pulled, what the evidence showed, and what alternatives exist.

What This Means for Patients

If you’re on a drug that gets withdrawn, it’s not the end of the road-but it is a wake-up call. Many patients don’t realize their medication might be on the chopping block. Oncology patients, in particular, have shared heartbreaking stories online. One woman on a breast cancer forum wrote: “I was on [withdrawn drug] for 18 months. My oncologist said it was standard. Now I know it didn’t help.”

Patient advocacy groups are cheering the new rules. The Cancer Research Institute called it “a crucial step toward protecting people from fake hope.” But the fear remains: what if the next drug you’re prescribed is one that’s already failing behind the scenes?

The truth is, you can’t always know. But you can ask. If your doctor prescribes a drug with accelerated approval, ask: “Has this been confirmed in a large trial? Are there any ongoing studies to prove it works?”

How the U.S. Compares to the Rest of the World

The U.S. used to be an outlier. Europe and Canada have long used “conditional approval,” where drugs are approved with strict requirements to prove effectiveness within a set time. If the company fails, the drug is pulled automatically.

The FDA didn’t have that power until 2023. Now, it’s closer to those systems. The new rules mirror the European Medicines Agency’s approach, giving the agency more leverage to demand proof after approval.

This shift matters. It means the U.S. is no longer the only country where patients might get stuck on a drug that doesn’t work-for years.

What’s Next?

The real test isn’t how fast the FDA can pull a bad drug-it’s how fast they can catch it before it harms people. The agency is now testing real-world data from electronic health records to spot problems early. Imagine if a drug starts showing up in hospital records as causing more liver damage than expected-before the next clinical trial even finishes.

Pharmaceutical companies are adapting too. Nearly 80% of major oncology drugmakers now include withdrawal scenarios in their risk plans. They know the old days of waiting for a scandal to force action are over.

But the pressure is still on. Evaluate Pharma predicts drug withdrawals will rise 25% between 2023 and 2027. That’s not because more drugs are failing-it’s because the system is finally working as it should.

Frequently Asked Questions

What You Can Do

Stay informed. If you’re on a drug approved under accelerated approval, ask your doctor if a confirmatory study has been completed. If you’re prescribed a new cancer drug, ask whether it’s been on the market for more than two years. If not, it might still be under review.

Don’t panic if your drug is withdrawn. Work with your provider to find alternatives. But do ask questions. The system is better now-but it still depends on you to be an active participant in your care.