INFO: FDA Alert, Special Statements and Warnings -- Celebrex and other NSAID's -- Dec 17, 04'

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http://www.fda.gov/bbs/topics/news/2004/new01147.html

FDA Statement

FOR IMMEDIATE RELEASEStatementDecember 20, 2004

Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA

FDA Statement on Celebrex DTC Promotion

On December 17, FDA asked Pfizer, Inc. to voluntarily suspend DTC advertising on Celebrex during the time the Agency is obtaining and evaluating the new and conflicting scientific data on adverse events associated with the drug. FDA also requested the company change the information provided to physicians to reflect the recommendations FDA made encouraging physicians to consider alternative therapies as they evaluate their individual patient needs.

Pfizer agreed to the broad suspension of its Celebrex promotion and to craft appropriate detailing to physicians that reflects the uncertainty of scientific data currently available.

http://www.fda.gov/cder/drug/infopage/celebrex/celebrex-hcp.htm

FDA ALERT 12/17/04:

FDA Alert for Practitioners on Celebrex (celecoxib)

FDA ALERT 12/17/04: Based on emerging information, including preliminary reports from one of several long term National Institutes of Health (NIH) prevention studies, the risk of cardiovascular events (composite endpoint including MI, CVA and death) may be increased in patients receiving Celebrex. FDA will be analyzing all available information from these studies to determine whether additional regulatory action is needed.

Special Warnings with Celebrex:

Celebrex and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get:

a burning stomach pain

black bowel movements that look like tar

vomit that looks like blood or coffee grounds

Celebrex and other NSAID medicines can cause serious allergic reactions that include swelling of the face, lips, tongue or throat. These allergic reactions may cause problems with breathing, swallowing, and wheezing. Serious allergic skin reactions have also happened.

General Precautions with Celebrex:

Celebrex and other NSAID medicines can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If these happen, stop taking Celebrex and call your health care provider right away.

Celebrex and other NSAID medicines can cause serious kidney problems that include sudden kidney failure or worsening of kidney problems that you already have.

Celebrex and other NSAID medicines can cause fluid retention (holding of water in your body) and swelling. Fluid retention can be a serious problem if you have high blood pressure or heart failure.

What should I tell my doctor or health care provider?

Tell your health care provider if you:

are trying to become pregnant, are already pregnant, or are breast-feeding

have or had angina (chest pain), heart attack or blocked artery in your heart

have kidney problems

have liver problems

have heart failure

have high blood pressure

retain fluids (hold extra body water and swell)

had an allergic reaction to aspirin or other NSAID medicines

had a serious stomach problem in the past

have or had any other medical problems or allergies

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Celebrex works or Celebrex may affect how your other medicines work. Your healthcare provider may have to adjust your dose or watch you closely if you take certain medicines. Celebrex cannot take the place of aspirin for prevention of heart attack or stroke. If you take aspirin for this purpose, do not stop taking aspirin without talking to your doctor.