Pfizer agrees with the recommendation of the joint meeting of the FDA
Arthritis Advisory Committee and Drug Safety and Risk Management
Advisory Committee that the available data do not support a conclusion
that naproxen has a lower risk of cardiovascular thrombotic events as
compared to other non-steroidal anti-inflammatory drugs (NSAIDs).
Based on Pfizer’s review of the data discussed, we believe there is
insufficient evidence to make this type of distinction. Differentiation
between NSAIDs on cardiovascular safety should be based on substantial
scientific evidence.
Pfizer is sponsoring a study that may provide substantial evidence.
PRECISION is a large, ongoing, well-controlled, randomized clinical
trial designed in agreement with FDA to assess the relative long-term
cardiovascular safety of CELEBREX compared to prescription doses of two
commonly prescribed NSAIDs, ibuprofen and naproxen, in the treatment of
arthritis pain. It is an important study that will provide meaningful
information on the cardiovascular safety of these medicines.
Although advisory committees provide recommendations to the FDA, FDA
makes final regulatory decisions.
Patient safety and appropriate use of our medicines are top priorities
at Pfizer. For more than 30 years, Pfizer NSAID medicines have helped
people relieve their headaches, arthritis symptoms and other causes of
pain or inflammation. We are committed to ongoing safety monitoring of
our medicines.
Copyright Business Wire 2014