Food and Drug Administration officials Thursday told Pfizer Inc. to take its COX-2 drug Bextra off the U.S. market and put a warning on Celebrex.
The FDA, based on recommendations from its Arthritis and Drug Safety and Risk Management Advisory Committee following a hearing in February, also asked manufacturers of all other prescription non-steroidal anti-inflammatory drugs to revise their labels to include the same box warning included on Celebrex.
Drugmakers selling NSAIDs also will have to include a medication guide for patients advising them of the potential for adverse events such as heart attack, stroke and gastrointestinal bleeding associated with this class of drugs.
Manufacturers of over-the-counter NSAIDs were asked to include more specific information about potential side effects
Manufacturers of over-the-counter NSAIDs were asked to include more specific information about potential side effects, including a warning about potential skin reactions.
FDA began to investigate the COX-2 drugs last fall, and then included all NSAIDs, following studies that showed Merck’s Vioxx, a COX-2 arthritis drug, doubled a patient’s risk of heart attack when taken longer than 18 months.