Vioxx sales may resume in the United States

Vioxx may be back soon in drugstores in the United States. According to the recommendation of the FDA panel, while Vioxx does increase the risk of heart attacks and stroke, it is safe enough to be sold in the United States. (Related article: Celebrex and Bextra have same risks as Vioxx, argued Merck)

Earlier the panel also voted to let Celebrex and Bextra remain on the market with black box warnings.

Vioxx was recalled voluntarily by Merck in September 2004 when it was found that Vioxx doubled the risk of heart attacks. Since then, Merck has been a target of hundreds of class action lawsuits that are scheduled to be tried in Louisiana.

The panel's advice is non-binding on the FDA but in most cases FDA follows the advice. It is expected that FDA will come up with a final decision on resuming sales of Vioxx within a matter of weeks. (Related article: FDA scientist argued that Vioxx should have never even been approved)

According to FDA's estimates as many as 140,000 Americans have been injured by Vioxx. Many consumer rights groups and doctors have demanded that the FDA ban the drug along with other Cox-2 drugs like Celebrex and Bextra. However, doctors would have been left with fewer choices of painkillers if all Cox-2 drugs were banned.

In summary, it means that all Cox-2 drugs will stay on the market in the United States simply because they are all dangerous to varying degrees. (Related article: Europe restricts, bans Cox-2 drugs)

The vote on Vioxx was very close with 17 members voting in favor of bringing it back on the market and 15 opposing the decision.

What does it mean for 140,000 Americans injured by Vioxx?

According to preliminary analysis, the decision has only minimal change on Vioxx litigation if they were actually hurt by the drug. The decision does help Merck to some extent since it will now start to receive revenue from Vioxx once again.

Recommended article: Australia limits or bans prescription of Cox-2 drugs