NEW YORK – The makers of celecoxib said today it will work with the U.S. Food and Drug Administration (FDA) to add expanded risk information in the celecoxib label following an FDA decision announced this morning to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including older non-specific drugs such as ibuprofen and naproxen.
The boxed warning for all nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib, will also contain information regarding gastrointestinal risk that is already included elsewhere in their current labels.
In addition, the FDA is asking manufacturers of all over-the-counter NSAIDs to revise their labeling to include more information on the cardiovascular and gastrointestinal risks as well as a warning about potential skin reactions.
The FDA and the company that makes celecoxib plan further discussions regarding the precise content of the celecoxib label. The company has accumulated extensive celecoxib clinical data over the past 10 years involving more than 40,000 patients. They also reaffirmed its commitment to conduct additional long-term clinical studies evaluating the benefits and risks of celecoxib.
The company also said it will work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.
Regarding valdecoxib, the other oral Cox-2 inhibitor of the same company, the FDA informed the company late yesterday that, in the agency’s view, valdecoxib’s cardiovascular risk could not be differentiated from other NSAID However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market.
The company respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of valdecoxib. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA. The company said it will explore options with the agency under which the company might be permitted to resume making valdecoxib available to physicians and patients.
In addition, at the request of European regulators, the company will also suspend sales of valdecoxib in the European Union.
The company was informed by the FDA of its conclusions regarding celecoxib and valdecoxib on Wednesday afternoon, one day after the company held a meeting with financial analysts.} The company received the request from the European regulators early Thursday morning. The company said it is evaluating the operational and financial impact of these actions.{s:r}
In the Philippines, the company’s affiliate has been in contact with the Bureau of Food and Drugs (BFAD) about these recent developments and will take appropriate measures based on those discussions.
