Opinion ID: 1211810
Heading Depth: 2
Heading Rank: 8

Heading: Vioxx's Labeling Modified to Include CV Risks (April 2002)

Text: Merck was not required to include the risk of CV events in its labeling until April 2002. The labeling ultimately incorporating that information explained the VIGOR study results and stated, the risk of developing a serious cardiovascular thrombotic event was significantly higher in patients treated with VIOXX ... as compared to patients treated with naproxen. ... The significance of the cardiovascular findings ... is unknown. App. at 553. This language was incorporated into the precautions section of the Vioxx labeling, rather than the warnings section. In a conference call discussing the labeling changes, a Merck spokesperson reiterated the company's belief that the effect seen in VIGOR were [sic] the results of the anti-platelet effect of naproxen. ... So, I think that's a position Merck has always had and now its [sic] quite clearly laid out in the labeling. App. at 559.