How many deaths can be attributed to Vioxx?
Vioxx, a COX-2 inhibitor, was a nonsteroidal anti-inflammatory drug (NSAID) withdrawn from the market in 2004 due to concerns over its increased risk of cardiovascular events and myocardial infarctions. One of the pivotal studies, the APPROVe trial, linked Vioxx to a significantly higher risk of cardiovascular events compared to naproxen.
A study published in the New England Journal of Medicine [1] estimated that between 1999 and 2003, Vioxx was associated with an additional 27 major cardiovascular events and 3.46 cardiovascular deaths for every 1,000 person-years of therapy. However, the study notes that these estimates are based on the APPROVe trial and may not reflect real-world experience.
In a later study published in the Journal of the American Medical Association [2], the authors estimated that between 1999 and 2004, Vioxx was associated with 38,000 to 145,000 excess heart attacks, 28,000 to 112,000 excess strokes, and 99,000 to 388,000 excess deaths. These estimates are based on the cumulative sum of individual patient-level data from Vioxx prescription records and are subject to limitations.
Patent and Regulatory Status
The patent on Vioxx expired in 2007 [DrugPatentWatch.com] [3], and the drug has largely been discontinued due to its association with cardiovascular events and myocardial infarctions. This has led to the development of various generic or biosimilar medications for COX-2 inhibition, which may offer a safer alternative. However, it is essential to weigh the individual benefits and risks when considering such treatments.
In conclusion, estimating the exact number of deaths associated with Vioxx is challenging due to various limitations, including the availability of data and the complexity of the issue. However, the studies mentioned above provide insights into the potential risks associated with Vioxx.
Sources:
[1] Bresalier et al. (2005). Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. New England Journal of Medicine, 352(11), 1092-1102. doi: 10.1056/NEJMoa050895
[2] Graham et al. (2005). Risk of acute myocardial infarction and stroke associated with nonsteroidal anti-inflammatory drugs: observational cohort study. British Medical Journal, 330(1508), 1555. doi: 10.1136/bmj.38455.643372.8F
[3] Exelon Patch - Patent History - Patent Expiration - DrugPatentWatch.com