Contact Us

Bextra
*    Denotes required field.

   * First Name 

   * Last Name 

   * Email 

Phone 

Cell Phone 

Street Address 

Zip Code 

City 

State 

Date you started taking this drug:

Date you stopped taking this drug:

Did you take more than 400 MG of Bextra a day?

Have any of the following side effects occurred? (Please check all that apply.)






Please further describe side effects:

For verification purposes, please answer the below question:
+
=

No Yes, I agree to the Parker Waichman LLP disclaimers. Click here to review.

Yes, I would like to receive the Parker Waichman LLP monthly newsletter, InjuryAlert.

please do not fill out the field below.


FDA, PHARMACIA UPDATE BEXTRA LABEL WITH NEW WARNINGS

Nov 15, 2002 | www.fda.gov

FDA and Pharmacia are advising health care professionals about new warnings and information in the product labeling of the drug Bextra (valdecoxib), a drug approved for treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain).

The labeling is being updated with new warnings following postmarketing reports of serious adverse effects including life-threatening risks related to skin reactions including Stevens Johnson Syndrome, and anaphylactoid reactions (serious allergic reactions). In addition, the labeling will state that the drug is contraindicated not to be used in patients allergic to sulfa containing products.

On November 13, 2002, Pharmacia, the manufacturer of Bextra sent letters to health care professionals advising them of postmarketing reports and new warnings that will be included in the drug label. Since the firm began marketing the drug in March of 2002, cases of the serious skin and hypersensitivity reactions have been reported. These included cases of Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiforme. Although these adverse events are rare, some of these patients required hospitalization.

Based on these reports, FDA has approved labeling changes for Bextra that include a warning for serious skin reactions. As these reactions can be life threatening, people who start Bextra and experience a rash should discontinue the drug immediately.


Related articles
Parker Waichman Accolades And Reviews Best Lawyers Find Us On Avvo