Update on Celebrex, Arcoxia, Prexige, & Bextra

Next week is going to be critical for the manufactures of arthritis drugs belonging to the category of Cox-2 drugs. A series of meetings have been organized by the US Food & Drug Administration (FDA) and European Medicines Agency (EMEA). The following are the major companies that will be presenting why their drugs should be on the market:

• Merck makes Vioxx (since recalled) and Arcoxia
• Pfizer (Celebrex and Bextra)
• Novartis (Prexige)

Below is an update on each drug based on the documents released by the manufacturers prior to the meeting:

Celebrex

Celebrex has gotten into a lot of trouble since the recall of Vioxx. As data disclosing more risks of taking Celebrex came out and Pfizer was warned by FDA of running misleading ads, consumer groups have been demanding that Celebrex be recalled. In data presented to FDA, Pfizer has chosen to ignore all research conducted by independent researchers. Instead it has submitted only Pfizer data from 41 of its own patient trials involving more than 40,000 patients that shows no evidence that Celebrex increased heart problems. While there is widespread speculation that Celebrex will be recalled, Wall Street analysts are betting that it will instead get a stronger warning. (Related article: Celebrex safety update)

Bextra

Bextra already carries a strong warning after its serious side effects were discovered. Kaiser Permanente has already banned the drug. Experts expect that if any COX-2 drug will be banned, it is more likely to be Bextra. Pfizer is not submitting any additional information, arguing that it is similar to Celebrex. (Related article: Bextra safety update)

Arcoxia

Since the recall of Vioxx, Merck wants to have another drug to capture the market share that it has lost (Related article: Vioxx recall may bankrupt Merck). The company's financials have been hurt and there is even speculation that the company may file for bankruptcy due to mounting class action lawsuits in injuries to 140,000 Americans.

But there is bad news for Merck. “The results appear to demonstrate that (Arcoxia) is worse than each comparator” with regard to deaths and serious cardiovascular problems, FDA staff reviewers comment in an analysis posted on the agency Web site. The drug is not sold in the US but is sold in 51 countries in Europe, Latin America and Asia. FDA is unlikely to approve this drug now.

Prexige

Prexige showed that it was safer on the gastrointestinal tract than other painkillers. But the risks of heart attacks, strokes and deaths were “similar” to what was seen with Vioxx, the FDA reviewers wrote in their analysis.

Recommended article: Vioxx side effects reconfirmed