<font color=red>Merck's Vioxx Label May Have Heart Warning Added, Analyst Says
By Joseph Richter
Whitehouse Station, New Jersey, Feb. 14 (Bloomberg) -- Merck & Co. may add a cardiovascular warning to the U.S. label of its Vioxx painkiller and an experimental follow-up drug, Arcoxia, which could put these drugs at a disadvantage to rivals, an analyst said.
The U.S. Food and Drug Administration may require Merck to include information about higher risk of heart attacks for Vioxx patients compared with those on an older painkiller, said Tim Anderson of Prudential Securities. A decision may come within a few weeks, he said.
Merck and Pharmacia Corp., maker of the Vioxx rival, Celebrex, are neck-and-neck in a race for new prescriptions for the painkillers. A warning on the Vioxx label might give an edge to Pharmacia and Pfizer Inc., which helps market Celebrex, Anderson said.
``We think it could be a slight net win'' for Pharmacia and Pfizer, he said in a report.
In a report on expected label changes for Celebrex and Vioxx, Anderson said that the FDA also may be looking at whether Merck's successor to Vioxx, a drug called Arcoxia, has a cardiovascular risk. The FDA may ask a committee of expert advisers from outside of the agency to review Arcoxia at a May meeting, Anderson said in a report.
``This would not necessarily mean the end of Arcoxia from a commercial perspective, but having a compromised label would clearly give (Pharmacia and Pfizer) more ammunition to reinforce the (cardiovascular) safety of their products,'' Anderson said.
Merck declined to comment on whether it had been notified about an Arcoxia panel.
``It's not appropriate for us to comment at all,'' said Chris Fanelle, a Merck spokeswoman. ``The decision to consult an advisory committee is up to the FDA.''
Shares of Whitehouse Station, New Jersey-based Merck fell 89 cents to $59.69. Shares of Peapack, New Jersey-based Pharmacia shares rose 41 cents to $40.45. |
