, Feb. 11, 2014
/PRNewswire/ -- Bayer HealthCare today issued the following press statement from Dr. Irene Laurora
, Vice President, US Medical Affairs, following a joint meeting of the Arthritis Advisory Committee (AAC) and Drug Safety Committee and Risk Management Advisory Committee (DSaRM) on February 10-11, 2014
. The joint Advisory Committee panel reviewed the data and analyses published since the last non-steroidal anti-inflammatory drug (NSAID) panel review in 2005 to further understand the relationship between cardiovascular thrombotic risk and prescription and over-the-counter non-aspirin NSAIDs already described in the class labeling.
While the Advisory Committee panel did not find the accumulated data supported a significant difference in cardiovascular risk for naproxen, as compared to other non-aspirin NSAIDs, Bayer HealthCare is pleased that a number of the Advisory Committee panelists agreed that the data are supportive of its low risk, and that there is a large body of evidence which consistently demonstrates that naproxen has a low CV thrombotic risk compared to other non-aspirin, non-steroidal anti-inflammatory drugs (NSAIDs). Further, a number of the panelists recommended that treatment guidelines and other information for healthcare professionals and their patients should communicate the differential lower risk of naproxen to other non-aspirin NSAIDs, so that physicians can consider this information as they treat patients.
Data collected for nearly 20 years indicates no signal (i.e. pattern) for OTC naproxen sodium and CV thrombotic and overall CV events. Like all non-aspirin OTC NSAIDs in the US, ALEVE labeling currently includes FDA-mandated CV warnings related to concerns if the product is used longer or at higher doses than directed on the label.
We will continue to work with the FDA to ensure appropriate information regarding OTC naproxen is communicated to consumers, patients and healthcare providers.
When taken as directed on the label, ALEVE is a safe and effective pain reliever, used by millions of people since its introduction as an OTC product 20 years ago. Like all non-aspirin OTC NSAIDs in the US, ALEVE labeling includes an FDA-mandated warning that "the risk of heart attack or stroke may increase if you use more than directed or for longer than directed." Patients with a history of heart disease or those at higher cardiovascular risk should talk to their doctor before use of ALEVE.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
The Consumer Care division of Bayer HealthCare is headquartered in Whippany, N.J. USA. Bayer's Consumer Care division is among the largest marketers of over-the-counter medications and nutritional supplements in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Aleve®, Alka-Seltzer®, Alka-Seltzer Plus®, Apronax®, Aspirin®, Bactine®, Bayer® Aspirin, Bepanthen®, Bepanthol®, Berocca®, Cal-D-Vita/Elevit®, Canesten®, Flanax®, Flintstones Vitamin, Midol®, One A Day® Vitamin, Phillips'® Milk of Magnesia, Redoxon®, Rennie®, Supradyn®, Talcid® and Vital 50 Plus®.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
SOURCE Bayer HealthCare