Vioxx (Rofecoxib) Dangers Known Earlier

Before the headlines hit about the dangers of using Vioxx (rofecoxib), researchers were already aware, say news reports.

Vioxx, a non-steroidal anti-inflammatory (NSAID), was made by Merck & Co. Inc., and introduced to the American market in 1999. The company then voluntarily pulled the drug from the market in September 2004, after there were multiple reports of increased risk of heart attack and stroke associated with long-term, high-dose use.

Six investigators from the Mount Sinai School of Medicine analyzed 30 randomized placebo-controlled trials involving Vioxx  and 20,152 individuals. They published their findings in the November 23 issue of Archives of Internal Medicine.

What the researchers found is disturbing:

Their analysis showed that safety concerns arose almost four years before the drug was withdrawn from the market. Dr. [Joseph] Ross and his colleagues found that as of December 2000 — when 21 of the 30 studies had been completed — there was a strong concern that patients taking Vioxx were at a greater risk for adverse events or death from cardiovascular conditions or blood clots. Thereafter, collected data through June 2001 showed Vioxx to be associated with a 35 percent increase in risk of a cardiovascular event or death. The association with cardiovascular risk strengthened as more data became available. As of April 2002, the pooled analysis showed a 39 percent increased risk, and as of September 2004, a 43 percent increased risk.

If this is true, and it seems to be, how can the company have gotten away with this?

~~~

Image: iStock.com