Celebrex, Bextra to stay with strong warning

The FDA panel that has been reviewing Cox-2 drugs like Vioxx, Celebrex, and Bextra unanimously agreed moments ago that both Celebrex and Bextra do cause heart problems in many patients. In other words, it did not agree with Pfizer's assertions that Celebrex and Bextra are safe drugs. However, the panel found that the drug do have some benefits, and therefore, there is no need to recall either Celebrex or Bextra at this time. (Related article: Pfizer may have not disclosed all Celebrex risks)

The panel has, however, recommended that Celebrex carry the strictest form of warning, highlighted in a black box, on the label. Pfizer's other drug, Bextra, also carries a black box warning. A black-box warning is a way to tell doctors and patients that the drug has risks and should be prescribed when there is no other alternative.

The European Medicines Agency (EMEA) and (Australian) Therapeutic Goods Administration came up with similar recommendations on Celebrex and Bextra.

Celebrex is a blockbuster drug for Pfizer and a lot of patients like it even though many studies have shown that the drug is no better than an over-the-counter painkiller. Many of these patients still pleaded with the FDA to leave the drug on the market. (Related article: Merck wants to sell Vioxx again)

Celebrex belongs to the Cox-2 class of drugs that are also called lifestyle drugs, meaning that they do not cure a disease but provide relief from a suffering. With very aggressive direct-to-consumer advertising, Pfizer convinced millions of Americans to take Celebrex. However, sales drop rapidly after the heart risks were disclosed in a series of studies in December 2004 and during January and February this year. (Related article: Pfizer warned by FDA for misleading Celebrex, Bextra advertisements)

Recommended article: FDA expert blasts Merck, Pfizer, and Cox-2 drugs