No, Is the drug Vioxx still available? A look back at its withdrawal

October 13, 2025 •

4 min read

On September 30, 2004, the pharmaceutical company Merck & Co. voluntarily withdrew its painkiller Vioxx (rofecoxib) from the worldwide market after a long-term study revealed an increased risk of cardiovascular events, including heart attack and stroke. As a result, the drug Vioxx is not still available for general prescription and use, a landmark event that profoundly impacted drug safety regulations globally.

Quick Summary

Vioxx was recalled in 2004 over safety concerns linking it to increased cardiovascular risks. The article explores the history of Vioxx, the reasons for its market withdrawal, the aftermath, and the safer alternatives now available for pain and arthritis management.

Key Points

Drug Status: The prescription drug Vioxx (rofecoxib) was voluntarily withdrawn by its manufacturer, Merck, in 2004 and is no longer available anywhere in the world.
Reason for Withdrawal: Vioxx was recalled due to an increased risk of serious cardiovascular events, including heart attack and stroke, especially with long-term use.
Regulatory Fallout: The scandal led to more stringent FDA regulations, including mandatory black box warnings on all NSAIDs regarding cardiovascular and gastrointestinal risks.
Class of Drug: Vioxx was a selective COX-2 inhibitor, a subclass of nonsteroidal anti-inflammatory drugs (NSAIDs).
Modern Alternatives: Alternatives include other NSAIDs (e.g., Celebrex, ibuprofen, naproxen) and non-NSAID options like acetaminophen, though all carry risks that should be discussed with a doctor.
Official FDA Action: The FDA officially withdrew approval for Vioxx in 2022, cementing its status as an illegal drug for distribution.
Enduring Impact: The Vioxx withdrawal is considered a pivotal moment in drug safety history, highlighting the need for vigilance even after a drug is approved for the market.

The Rise of a Blockbuster

Vioxx, the brand name for the drug rofecoxib, was a selective COX-2 inhibitor launched in the United States in 1999. As a prescription nonsteroidal anti-inflammatory drug (NSAID), its primary use was to treat the pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and other acute pain conditions. It quickly became a popular "blockbuster" drug, with annual sales exceeding $2.5 billion for manufacturer Merck. Its key selling point was the promise of being gentler on the stomach than traditional NSAIDs, like ibuprofen and naproxen, which can cause gastrointestinal side effects such as ulcers and bleeding. This perceived safety advantage led millions of people worldwide to use the medication.

Unveiling the Hidden Risks and the Recall

Despite initial success, Vioxx's journey was plagued by growing safety concerns. In 2000, results from the VIGOR (Vioxx Gastrointestinal Outcomes Research) study revealed a troubling signal: while Vioxx caused fewer gastrointestinal issues than naproxen, it was associated with a higher rate of heart attacks. This raised the first major red flags about its cardiovascular safety. Merck downplayed the findings, but the concerns persisted, prompting more extensive investigations.

The final blow came from the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial, which began in 2000. It was designed to see if Vioxx could prevent colon polyps. The trial was halted prematurely in 2004 when data showed that patients taking Vioxx for more than 18 months had a significantly increased risk of serious cardiovascular events, including heart attacks and strokes, compared to those taking a placebo.

On September 30, 2004, with compelling evidence of a serious and life-threatening risk, Merck announced the voluntary worldwide withdrawal of Vioxx. This action came as a shock to the 2 million people still using the drug at the time and the healthcare community at large. It was one of the largest and most impactful voluntary drug recalls in history.

The Aftermath and Regulatory Changes

The withdrawal of Vioxx triggered a cascade of events:

Legal Scrutiny: The recall led to tens of thousands of personal injury lawsuits against Merck, with allegations that the company had concealed or downplayed the cardiovascular risks for years. In 2007, Merck agreed to a settlement of nearly $5 billion to resolve the majority of these claims.
Enhanced FDA Oversight: The Vioxx scandal prompted a re-evaluation of the FDA's drug approval and monitoring processes. In the aftermath, the agency implemented more stringent regulations for NSAIDs. This resulted in mandatory boxed warnings on the labels of all prescription NSAIDs, including those in the same class as Vioxx, to highlight potential cardiovascular and gastrointestinal risks.
Fate of Other COX-2 Inhibitors: The scrutiny extended to other COX-2 inhibitors. Another drug, Bextra (valdecoxib), was also withdrawn from the U.S. market in 2005 due to similar safety concerns, while Celebrex (celecoxib) remains available with a prominent black box warning.
Official FDA Withdrawal: In 2022, the FDA officially withdrew approval for Vioxx (rofecoxib) tablets and suspension, as Merck had not provided the information required to re-introduce the medication to the U.S. market following the 2004 withdrawal. This solidified its permanent status as an unavailable drug for general use.

Modern Alternatives to Vioxx

For those who once relied on Vioxx for pain and inflammation, several alternative treatment options are available. Any choice of medication should be made in consultation with a healthcare provider, who can assess individual risk factors for cardiovascular and gastrointestinal complications.

Over-the-Counter Alternatives:

Traditional NSAIDs: Include ibuprofen (Advil, Motrin) and naproxen (Aleve). While effective, they carry risks of gastrointestinal bleeding and should be used at the lowest effective dose for the shortest possible duration.
Acetaminophen: Found in products like Tylenol, acetaminophen is a non-NSAID pain reliever that does not carry the same cardiovascular or gastrointestinal risks. It is a good first-line option for many types of pain.

Prescription Alternatives:

Celebrex (celecoxib): The only remaining COX-2 inhibitor on the U.S. market, Celebrex comes with a black box warning about its cardiovascular and gastrointestinal risks.
Other NSAIDs: Various other prescription NSAIDs are available, each with its own risk profile.
Lifestyle Modifications: For conditions like arthritis, non-pharmacological approaches like physical therapy, weight management, and regular exercise are often recommended alongside or in place of medication.

Comparison Table: Vioxx vs. Common Alternatives


Feature	Vioxx (rofecoxib)	Celebrex (celecoxib)	Ibuprofen (Advil, Motrin)	Naproxen (Aleve)
Current Status	Permanently withdrawn (2004)	Available with Black Box Warning	Widely available (OTC & Rx)	Widely available (OTC & Rx)
Drug Class	Selective COX-2 Inhibitor	Selective COX-2 Inhibitor	Non-selective NSAID	Non-selective NSAID
Gastrointestinal Risk	Claimed lower risk than traditional NSAIDs, but no longer relevant	Lower risk than traditional NSAIDs, but still carries a warning	Higher risk of ulcers/bleeding than COX-2 inhibitors	Higher risk of ulcers/bleeding than COX-2 inhibitors
Cardiovascular Risk	Increased risk of heart attack/stroke led to withdrawal	Black Box Warning for increased risk of heart attack/stroke	Known risk, exacerbated by long-term, high-dose use	Known risk, exacerbated by long-term, high-dose use
Best Used For	N/A (Recalled)	Arthritis, pain management, shorter durations	Short-term pain, fever	Longer-lasting pain, inflammation

Conclusion

The story of Vioxx serves as a critical lesson in pharmacology and drug safety. The initial promise of a safer painkiller was overshadowed by a serious, life-threatening cardiovascular risk that was only fully understood after widespread use. As a result, the drug Vioxx is no longer available, and its withdrawal serves as a stark reminder of the complexities and potential dangers of pharmaceutical products, underscoring the importance of post-market surveillance and stringent regulatory measures to protect public health. Anyone currently seeking pain management should consult a healthcare professional to discuss safe and appropriate alternatives.

Note: For more information on the FDA's strengthened labeling requirements for NSAIDs following the Vioxx recall, consult their official website.

Frequently Asked Questions

Vioxx was a prescription medication, not available over-the-counter. It was used to treat pain and inflammation from conditions like arthritis.

Vioxx worked by selectively inhibiting the COX-2 enzyme, which can also affect the production of substances that help protect the heart. Blocking this process was linked to a higher risk of blood clots and subsequent heart attacks and strokes, particularly with chronic use.

Patients who previously used Vioxx have several alternatives. These include other NSAIDs like ibuprofen (Advil) and naproxen (Aleve), the remaining COX-2 inhibitor Celebrex, and non-NSAID pain relievers like acetaminophen (Tylenol). The choice of medication should be discussed with a healthcare provider to weigh the risks and benefits.

No, the recall of Vioxx in 2004 was voluntary, initiated by Merck. The FDA agreed with the company's assessment of the safety concerns and issued a public health advisory at the time.

Both Vioxx and Celebrex are selective COX-2 inhibitors, but Vioxx was withdrawn due to its cardiovascular risks. Celebrex remains on the market but with a prominent 'black box' warning about similar cardiovascular and gastrointestinal risks.

The Vioxx recall prompted the FDA to tighten regulations for NSAIDs. This included requiring black box warnings on all prescription NSAIDs to highlight cardiovascular and gastrointestinal risks and increasing the scrutiny of new and existing drugs.

While it is possible for a drug to be re-introduced under new circumstances (e.g., for a rare, specific condition), Vioxx's official FDA approval was withdrawn in 2022. For general use, its return is highly unlikely given the substantial safety concerns and regulatory landscape.