The world’s largest pharmaceutical company, Pfizer, has received the wrath of the US Food and Drug Administration over a series of advertisements for its Celebrex (celecoxib) and Bextra (valdecoxib) painkillers, which the agency has deemed misleading.
In a warning letter dated January 10, but posted on its website yesterday, the FDA said that five television and print ads failed to disclose side effects and other important risk information, and made “unsubstantiated effectiveness claims.” The agency notes that both Celebrex and Bextra are contraindicated for several patient populations, and include warnings of serious gastrointestinal effects. In addition, Bextra’s label contains a warning over the risk of serious, possibly life-threatening skin reactions [[10/12/04c]].
The agency has asked the company to immediately stop using the ads in question and submit its plan of how it plans to comply with the request. However, it notes that the company agreed last month to suspend direct-to-consumer advertising for Celebrex after two long-term clinical trials suggested the drug was linked to a heightened risk of suffering a heart attack [[20/12/04a]], [[21/12/04b]]. “The seriousness of the violations concerning your promotion of Celebrex… would generally have warranted a Warning Letter,” the agency stated, but went on to say: “However, in light of your recent agreement to a voluntary suspension on all consumer promotion for Celebrex, we do not feel that is appropriate at this time. You should be aware, however, of the serious nature of the violations described above and act to avoid disseminating similarly misleading promotion for your products in the future.”
