FDA asks Pfizer to pull Bextra® from the market

04-07-05

The FDA has asked Pfizer, Inc. to withdraw its controversial drug Bextra® (valdecoxib) from the market. The FDA action on Bextra® is a result of the agency's conclusion that "the overall risk vs. benefit profile for the drug is unfavorable." Pfizer has agreed to the request.

Regulators also called for a so-called black box warning on the drug maker’s Celebrex®, another drug in the family. The black-box warning is the most serious warning required by the FDA, and it greatly limits a drug's usage and appeal as well as a company's advertising efforts.

Additional verticals pace Bextra® generated $1.29 billion in sales for New York-based Pfizer last year, about 2.4 percent of total revenue, while Celebrex® brought in $3.3 billion, or 6.3 percent.

All of the drugs in the Cox-2 family have raised concerns that they increase the risk of heart attacks in some patients.  Bextra® has also been associated with a rare and potentially deadly skin disease Stevens Johnsons Syndrome, Toxic Epidermal Necrolysis ("TEN") and drug reaction with Eosinophilia and systemic systems ("DRESS").

The last updated FDA report had 87 reports of the very painful and sometimes deadly skin disease Stevens Johnsons syndrome. Of these 87 cases, 36 people were hospitalized, including 4 deaths.

Pfizer® has agreed to suspend sales and marketing of Bextra® in the U.S., pending further discussions with the agency. Pfizer has agreed to work with the FDA on the boxed warning for Celebrex®. The FDA is asking manufacturers of all other prescription non-steroidal anti-inflammatory drugs (NSAID) to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex® and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.