Due to concerns over potential negative side-effects to both the gastrointestinal and cardiovascular systems, the European Committee for Proprietary Medicinal Products (CPMP) has recommended that COX-2 Inhibitors be required to carry more detailed warnings.

While the current crop of COX-2 Inhibitor medications available in the European Union (EU) are still considered to be beneficial to patients, the possibility that some of the body’s essential systems can be compromised was reason enough to issue the advisory. The next step in the process requires the European Commission to ratify the CPMP’s recommendations, which could take up to three months.

“To promote the safe use of the products, the committee recommends adding or strengthening warnings, in particular recommending caution for patients with underlying gastrointestinal and cardiovascular risks. The committee also recommends adding (or modifying) warnings concerning the risk of severe skin and hypersensitivity reactions,” read the CPMP’s review that was initiated by French medical professionals in July of 2002.

France cited Article 31 of the Community code on human medicines as the motivation behind the request. Upon review, the CPMP found that, despite clinical findings that indicated potential risk, the overall “benefit/risk profile of these products remains positive for the target patient populations.”

Currently, there are five COX-2 Inhibitors available in the EU: That group includes, celecoxib (Celebrex), etoricoxib (Arcoxia), parecoxib (Dynastat), rofecoxib (Vioxx) and valdecoxib (Bextra). All of these substances are to be included in any future mandated warnings.

-- Source: Rheumawire, www.jointandbone.org