Arcoxia approval delayed
Merck, the maker of now-banned drug Vioxx, has been trying to get an approval from the FDA for another arthritis drug marketed under the brand name Arcoxia (medical name “etoricoxib“). The company’s efforts intensified after the recall of Vioxx. However, as controversy continues over the safety of all Cox-2 drugs and even the safety of NSAIDs, the FDA has been more cautious about granting approvals.
Bextra, a similar drug made by Pfizer, was banned in April this year, and Celebrex has received a strong black box warning. Other painkillers like Ibuprofen and Diclofenac have also been linked to increased risk of heart attacks. Naproxen (Aleve) and Mobic are all centers of controversy as experts debate their safety.
Merck is now reporting that FDA has still not granted it permission to sell Arcoxia in the United States till further safety and efficacy studies are completed. Many medical experts believe that whole class of Cox-2 drugs are neither safer nor better for arthritis pain relief. They also happen to be far more expensive than over-the-counter painkillers. These trials are being monitored by a Data Safety Monitoring Board (DSMB) responsible for the ongoing safety of the trials. The DSMB met recently and recommended that the studies continue as planned. Merck remains blinded to the clinical data from these trials.
Recommended articles
Vioxx recall lawsuits to exceed 100,000
If you enjoyed this post, please consider to leave a comment or subscribe to the feed and get future articles delivered to your feed reader.
Comments
No comments yet.
Sorry, the comment form is closed at this time.