Bextra May Get Black Box Warning

Pfizer Says Bextra Can Cause Stevens-Johnson Syndrome

In November 2002, Pfizer announced in a Dear Doctor letter to health professionals that Bextra can cause a potentially life threatening drug reaction called Stevens-Johnson Syndrome.

More recently, in November 2004, Pfizer said that the FDA may require them to put a Black Box warning on the drug's label to alert patients about the Stevens-Johnson Syndrome risk associated with the use of Bextra. A 2005 study in Drug Safety examined the cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) in COX-2 drugs and found Bextra to have the highest incidence rate.

Stevens-Johnson Syndrome can cause the skin, mouth, and eyes to form blisters. It is most likely to appear within two weeks of taking Bextra. In the letter, Pfizer warns of several possible skin reactions associated with Bextra:

Since BEXTRA was approved by the FDA on November 16, 2001, in postmarketing experience, rare spontaneous reports of hypersensitivity reactions (i.e., anaphylactic reactions and angioedema) and skin reactions, including cases of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), exfoliative dermatitis and erythema multiforme, have been received for patients treated with BEXTRA. These cases, some of which were serious/life threatening,have occurred in patients with and without a history of allergic-type reactions to sulfonamides.

Bextra has also been linked to heart attack and stroke risk in a study released in November 2004.

Read more on our Bextra Information Page >>