Today the US Food and Drug Administration recommended new boxed warnings and medication guides for most nonsteroidal anti-inflammatory drugs (NSAIDs) to highlight the potential for increased cardiovascular risks and gastrointestinal bleeding. The agency made special mention of Pfizer’s blockbuster celecoxib (Celebrex), advising clinicians to prescribe the lowest effective dose and urging the company to commit to long-term study to address the safety of celecoxib and mobic compared with naproxen and others.
Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday. “Today’s actions protect and advance the health of the millions of Americans who rely on these drugs every day,” Dr Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told the press.Pfizer, already reeling over urgings by international regulators to remove valdecoxib (Bextra) from the market, said it would work with the FDA on its new recommendations. “Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label,” the company said in a statement. “Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40 000 patients.” The company said that it would conduct additional long-term clinical studies evaluating the benefits and risks of celecoxib and that it would work closely with the FDA to develop an additional medication guide to assist healthcare professionals and patients.”In reaching these decisions, the FDA has carefully considered the available data on all of the NSAIDs,” the agency said in a news release, pointing out that considerations included presentations, discussions, and votes from the advisory committees deliberating this past February over the benefits and risks of these products. The FDA says it will work closely with manufacturers to ensure that all requests are quickly put into action.Recommendations for celecoxib – Include boxed warning alerting of cardiovascular and gastrointestinal risk. – Contraindicate for use in patients who have recently undergone coronary artery bypass surgery. – Encourage prescribers to discuss with patients the potential benefits and risks of celecoxib and other treatment options. – Encourage the use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals. – Include new medication guide as part of product labeling, further informing patients. – Promote additional long-term study to address safety of celecoxib compared with naproxen and other appropriate drugs.Recommendations for prescription NSAIDs – Include boxed warning alerting of cardiovascular and gastrointestinal risk. – Contraindicate for use in patients who have recently undergone coronary artery bypass surgery. – Encourage the use of the lowest effective dose for the shortest duration consistent with individual patient treatment goals. – Include new medication guide as part of product labeling, further informing patients. – Conduct and submit a review of available controlled clinical-trial databases. Recommendations for over-the-counter NSAIDs – Include boxed warning alerting of cardiovascular and gastrointestinal risk for all products containing ibuprofen, naproxen, and ketoprofen. – Offer specific instructions about which patients should seek the advice of a physician before using these drugs. – Incorporate stronger reminders about limiting the dose and duration of treatment. – Issue warnings about potential skin reactions.The FDA points out that long-term controlled clinical trials have not been conducted with most NSAIDs. “However,” the agency says, “the available data suggest that use of these drugs may increase CV risk. It is very difficult to draw conclusions about the relative CV risk among the COX-2 selective and nonselective NSAIDs with the data available.” As a result, the FDA says it will work with sponsors and other stakeholders such as the National Institutes of Health to encourage additional long-term controlled clinical trials of nonselective NSAIDs to further evaluate the potential for increased risk.The FDA says it will continue to notify healthcare providers and patients in a timely fashion as new information becomes available. In the meantime, the agency urges clinicians and patients to report adverse-event information to the MedWatch program by telephone (1-800-FDA-1088), fax (1-800-FDA-0178), or online.(Source: Joint and Bone: April 2005.)