Bayer HealthCare’s Consumer Care Division said today it was pleased that discussions by the U.S. Food and Drug Administration (FDA) Arthritis and Drug Safety and Risk Management Advisory Committees clarified conflicting reports about the safety of Aleve® that have confused and, in some instances, alarmed consumers and health care professionals.The discussion at the meeting of the Advisory Committees affirmed the safety of Aleve and distinguished the safety profile of naproxen, the active ingredient in Aleve, from selective COX-2 inhibitors and other non-selective nonsteroidal anti-inflammatory drugs (NSAIDs), based on the weight of clinical data presented at the meeting. Some members of the panel even suggested that naproxen should be the standard by which future pain relievers should be measured for cardiovascular safety.
The presentations and discussions before the Committees also clarified that the widely publicized suspension of the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) on Dec. 20, 2004 was precipitated not by Aleve safety concerns, but rather by administrative and practical issues.
Bayer presented data to the Committees that underscored the nearly 30-year safety profile of naproxen. Bayer’s naproxen sodium formulation has been sold as an over-the-counter (OTC) product under the trade name Aleve since 1994.
"The recommendations and findings discussed by the Committees support our confidence that Aleve is safe and effective when taken as directed," said Erica Peitler, senior vice president of research and development. "We are committed to the welfare of our consumers and appreciate the help of the Committees in restoring public confidence in Aleve."
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