Why was vioxx discontinued?

Why was Vioxx taken off the market?

Merck withdrew Vioxx (rofecoxib) in September 2004 after a large study showed it doubled the risk of heart attack and stroke compared with placebo. The company acted within days of seeing the data and removed the drug worldwide.

How long was Vioxx on the market before safety concerns surfaced?

The FDA approved Vioxx in 1999. Early trials focused on gastrointestinal safety versus older NSAIDs, but cardiovascular signals appeared in later studies. By 2001 some researchers urged caution, yet the drug remained available until the 2004 trial results forced withdrawal.

What did the APPROVe trial reveal?

APPROVe tested Vioxx for preventing colon polyps. After 18 months, participants on the drug had roughly twice the rate of heart attacks and strokes as those on placebo. This was the first clear evidence of increased cardiovascular risk at the approved dose, prompting immediate action.

Why did Merck face lawsuits after the withdrawal?

Patients who suffered heart attacks or strokes while taking Vioxx filed thousands of personal-injury suits. Internal company documents showed Merck knew of possible heart risks years earlier, leading to accusations that safety data had been downplayed. Most cases settled; Merck paid about $4.85 billion in 2007 to resolve the bulk of claims.

Did the Vioxx withdrawal change how drugs are monitored?

The episode accelerated requirements for larger cardiovascular-safety trials before and after approval of new pain drugs. Regulators also tightened rules on post-marketing studies and direct-to-consumer advertising for drugs with potential heart risks.

When did Vioxx patents expire?

The main U.S. patents covering rofecoxib expired in 2013–2014, years after the drug was already off the market. No generic versions reached patients because the withdrawal preceded patent expiry.