Drug Withdrawals and Recalls: Why Medications Get Removed from the Market

When a drug you’ve been taking suddenly disappears from pharmacy shelves, it’s not just a supply issue. It’s often the result of a safety alarm that went off too late. Between 2010 and 2020, about 12.7% of drugs approved under the FDA’s accelerated pathway were pulled from the market - not because they were fake, but because they didn’t actually work. And in some cases, patients kept getting them for years after the evidence proved they were useless.

How a Drug Gets Approved - and Why That’s Not the End of the Story

The FDA doesn’t approve drugs because they’re perfect. It approves them because, at the time, the benefits seem to outweigh the risks. For life-threatening illnesses like cancer or ALS, that bar is lower. That’s where accelerated approval comes in. Instead of waiting years for proof that a drug extends life or improves quality of life, the FDA lets companies use a surrogate endpoint - like tumor shrinkage or a blood marker - as a stand-in for real-world benefit.

It’s a fast track. But fast tracks need brakes. And for decades, the brakes were broken.

Take Makena, a drug approved in 2011 to prevent preterm birth in women with a history of early delivery. The approval was based on a small study showing it reduced preterm births. But a much larger, more rigorous trial in 2020 proved it didn’t work. The FDA didn’t pull it until 2022 - over two years after the evidence was clear. During that time, an estimated 150,000 women received a drug that offered no benefit.

This wasn’t an accident. It was the system working as designed - poorly.

The Old System: Years of Waiting After the Evidence Was In

Before 2023, the FDA had no clear timeline for pulling drugs. Once a drug was approved, even under accelerated terms, the agency had to wait for the sponsor to complete a post-approval study. Then, if the study failed, the FDA had to review the data, notify the company, give them time to respond, hold meetings, and sometimes even convene an advisory committee. The whole process took an average of 46 months - nearly four years.

That’s longer than the time it takes to get a PhD. And during that time, doctors kept prescribing. Patients kept taking. And the data kept piling up: a 2023 study from Penn LDI found that 26% of patients eligible for these drugs received them even after the confirmatory trial failed. In small cell lung cancer cases, that number jumped to 41%.

One patient, diagnosed with metastatic breast cancer, wrote on a patient forum in 2022: “I was on [withdrawn drug] for 18 months before the trial failed. My oncologist said it was standard of care. Now we know it didn’t help.”

That’s the human cost of a slow system.

The 2023 Fix: A New Way to Pull Dangerous or Useless Drugs

In December 2023, Congress passed the Consolidated Appropriations Act - and with it, a major overhaul of how the FDA handles drug withdrawals. For the first time, the agency got clear authority to move quickly when drugs fail to deliver.

Under the new rules, the FDA can start withdrawal proceedings if:

• The drug sponsor doesn’t conduct required post-approval studies on time
• The confirmatory study doesn’t prove the drug works
• Real-world data or independent studies show the drug is unsafe or ineffective
• The company promotes the drug with false or misleading claims

The process is now structured. The FDA must notify the company within 30 days of proposing withdrawal. The company gets 60 days to request a meeting. A final decision must come within 180 days. That’s a far cry from the old 46-month wait.

The first drug pulled under this new rule was an ALS treatment in August 2023. The FDA didn’t wait. They acted.

Voluntary vs. Mandatory: Who Pulls the Plug?

Not all withdrawals are forced. Sometimes, companies pull their own drugs. This is called a voluntary withdrawal. It can happen for many reasons - declining sales, manufacturing issues, or even a change in business strategy. But the FDA only considers a drug “withdrawn from sale” if the reason is safety or effectiveness.

A temporary stockout? Not a withdrawal. A recall because of a bad batch? Not a withdrawal. But if the drug is pulled because it doesn’t work - or causes unexpected harm - that’s a withdrawal, no matter who initiates it.

The key difference? Voluntary withdrawals don’t trigger the same public notices or Orange Book updates as mandatory ones. That’s why pharmacists and doctors still get confused. A 2022 survey found 63% of pharmacists struggled to interpret the Orange Book’s withdrawal listings - the official federal list of drugs pulled for safety or effectiveness reasons.

Who’s Affected - and How?

The biggest impact? Cancer patients. Oncology drugs make up 40% of all accelerated approvals. And they’re also the most likely to be withdrawn. About 26% of accelerated approval cancer drugs have been pulled since 2010. That’s nearly one in four.

Patients don’t always know. Many are told their treatment is “standard of care.” They trust their doctors. They don’t check the FDA’s website. And even if they did, the information isn’t always easy to find.

Doctors face their own challenges. When a drug is withdrawn, they have to switch patients - fast. A 2023 ASCO guide found oncology clinics needed an average of 72 hours to develop new treatment plans. For someone with aggressive cancer, those 72 hours matter.

And then there’s the emotional toll. Reddit threads like “How many of you have been on drugs later withdrawn?” have hundreds of comments. Most express anger - not at the drug, but at the system that let them take it for years.

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

The U.S. isn’t alone in pulling drugs. The European Medicines Agency (EMA) and Health Canada have long used conditional approval - where drugs are approved with strict conditions, and failure to meet them means automatic withdrawal. The FDA didn’t have that power. It relied on Postmarketing Required (PMR) studies, which were slow and rarely enforced.

The 2023 law changed that. Now, the FDA is borrowing from the EMA’s playbook. It’s not perfect, but it’s closer to international standards.

The big difference? Speed. In Europe, if a drug fails its confirmatory trial, it’s often pulled within months. In the U.S., it used to take years. Now, it’s moving faster - but only for drugs approved after 2023. The old ones? They’re still stuck in the slow lane.

What’s Next? Real-World Data and Faster Decisions

The FDA is now testing a new system using real-world data from Flatiron Health - a database of electronic health records from cancer clinics across the U.S. Instead of waiting for a formal clinical trial, regulators can now look at how drugs are performing in the real world.

If a drug shows no benefit in thousands of real patients, the FDA can act - without waiting for a sponsor’s study. This could cut withdrawal times even further.

The goal? Reduce the average withdrawal time from 46 months to under 12. Commissioner Robert Califf says it’s possible. And with 12 dedicated scientists now working on withdrawal cases, they’re trying.

The Big Risk: Too Fast, Too Harsh?

Not everyone is cheering. Pharmaceutical companies warn that faster withdrawals could scare off innovation. If a drug for a rare disease is pulled too quickly, will companies still invest in developing it?

That’s a real concern. But the data suggests the opposite. The drugs being pulled aren’t breakthrough cures. They’re drugs that were approved on weak evidence, then failed when tested properly. The system didn’t need to be more lenient - it needed to be smarter.

The real danger isn’t removing ineffective drugs. It’s letting them stay on the market for years while patients suffer side effects for no benefit.

What You Should Know If You’re Taking a New Drug

If you’re prescribed a new cancer drug, ALS treatment, or any medication approved under accelerated approval:

• Ask: “Is this approved under accelerated approval?”
• Ask: “What’s the confirmatory study? When will results be available?”
• Ask: “Will I be notified if this drug is pulled?”

Don’t assume your doctor knows the full story. Many don’t. The FDA’s withdrawal notices are buried in the Federal Register. They’re not in your doctor’s EHR system.

Keep track. If your drug is pulled, you have the right to know why - and what your alternatives are.

Final Thought: Trust, But Verify

Medications aren’t safe just because they’re on the shelf. They’re safe because regulators, scientists, and patients keep asking questions. The 2023 reforms are a step forward - but they’re only as good as their execution.

The next Makena is already out there. The question isn’t whether it will be found. It’s whether the system will act fast enough to stop it before another 150,000 people are exposed.