What were the adverse effects of Rofecoxib (Vioxx) on patients, noting it is not a vaccine, but a nonsteroidal anti-inflammatory drug (NSAID)?

From the Guidelines

Vioxx was not a vaccine but a prescription pain medication (rofecoxib) that was withdrawn from the market in 2004, and it is estimated that approximately 88,000 to 140,000 people suffered heart attacks and strokes linked to Vioxx use in the United States alone, with an estimated 38,000 to 60,000 deaths. The medication was a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) used to treat arthritis, acute pain, and menstrual symptoms. According to the American Heart Association 1, the use of COX-2 inhibitors, including Vioxx, has been associated with an increased risk of cardiovascular events, including myocardial infarction, stroke, and sudden cardiac death. The Adenomatous Polyp Prevention on Vioxx trial, which was stopped after 36 months, revealed a 2 times greater risk of stroke, myocardial infarction, and sudden cardiac death among those taking rofecoxib 25 mg/day 1.

Key Points

• Vioxx was withdrawn from the market in 2004 due to increased cardiovascular risks
• Estimated 88,000 to 140,000 people suffered heart attacks and strokes linked to Vioxx use in the US
• Estimated 38,000 to 60,000 deaths linked to Vioxx use in the US
• Vioxx was a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID)
• Use of COX-2 inhibitors, including Vioxx, has been associated with an increased risk of cardiovascular events

Recommendations

• Patients who have experienced cardiovascular events while taking Vioxx should be closely monitored and managed by their healthcare provider
• Alternative pain management options should be considered for patients at high risk of cardiovascular events
• Healthcare providers should carefully weigh the benefits and risks of using COX-2 inhibitors, including Vioxx, in patients with a history of cardiovascular disease or those at high risk of cardiovascular events 1.

From the Research

Vioxx Harm

• The Vioxx drug, also known as rofecoxib, was withdrawn from the market in 2004 due to concerns about the risk of heart attack and stroke with long-term use 2.
• Studies have shown that patients taking rofecoxib had a greater risk of having any cardiovascular event and had a greater risk of having a non-fatal myocardial infarction compared to patients taking naproxen 2.
• The exact number of people harmed by the Vioxx drug is not specified in the provided studies, but it is known that the drug was associated with an increased risk of cardiovascular events 2, 3.
• Rofecoxib was found to be effective in treating pain and inflammation, but its use was limited due to the increased risk of cardiovascular events 4, 5, 6.

Cardiovascular Risks

• The cardiovascular risks associated with rofecoxib cannot be attributed to the drug alone, as all non-aspirin NSAIDs pose some cardiovascular risks 3.
• The COX-2 specificity of rofecoxib is one factor associated with increased cardiovascular risks, but traditional NSAIDs also have significant COX-2 specificity 3.
• Clinicians should consider the cardiovascular risks of NSAIDs when prescribing them, rather than focusing solely on decreasing gastrointestinal risks 3.

Gastrointestinal Risks

• Rofecoxib was found to have a lower rate of gastrointestinal events, such as ulcers and bleeds, compared to traditional NSAIDs like naproxen 2, 4, 5.
• The gastrointestinal safety profile of rofecoxib was similar to that of placebo, making it a safer alternative for patients at risk of developing gastrointestinal complications 4, 5.