Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer HealthCare's consumer care division has reaffirmed its confidence in its Aleve painkiller, after discussions by an FDA advisory panel clarified conflicting reports about the drug's safety.
Subscribe to our email newsletter
The discussion at the meeting of the Arthritis and Drug Safety and Risk Management 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 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, according to Bayer.
The presentations and discussions before the committees also clarified that the widely publicized suspension of the Alzheimer’s trial, ADAPT, in December 2004, came about due to administrative and practical issues rather than Aleve safety concerns.
“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 R&D. “We are committed to the welfare of our consumers and appreciate the help of the Committees in restoring public confidence in Aleve.”