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Arthritis Drug Bextra Pulled; FDA Requests Revised Label on OTC NSAIDS

Thursday, April 7th, 2005 .

What should I do if I am currently taking Bextra?

You should speak with your doctor immediately to investigate options to discontinue Bextra and seek alternative treatments.

Stevens-Johnson Syndrome

In addition to cardiovascular problems, Bextra has been linked to a rare but sometimes fatal skin condition known as Stevens-Johnson Syndrome (SJS). SJS is a severe inflammatory eruption of the skin and mucous membranes, either following a respiratory infection, or, as in the case of Bextra-linked SJS cases, as an allergic reaction to a drug. For more information on SJS, see The Stevens Johnson Syndrome Foundation. According to Pfizer, SJS is the primary reason the FDA requested they pull Bextra.

Celebrex

With the withdrawal of Bextra and Vioxx, Celebrex is the only two selective COX-2 agent currently on the U.S. market. Important Celebrex information:

Non-Selective NSAIDS

From the FDA: “Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.” Among the OTC NSAIDS: Ibuprofen (Motrin, Advil), Ketoprofen (Actron), and Naproxen (Aleve). See a more complete list of non-selective NSAIDS.

Defective drug injury claims: seeking a personal injury lawyer

Do you think you have been wrongfully injured by a defective drug? If you would like to seek the counsel of a attorney regarding your injuries as a result of a defective drug, you can contact defective drug lawyer at GPW here. For over twenty years, the lawyers of GPW have represented people injured by defective drugs. Learn more about GPW.


COX-2 Selective (NSAIDs)
Chemical Name Brand Name Status
Celecoxib Celebrex Revised labeling, April ’05
Valdecoxib Bextra Pulled from market, April ’05
Rofecoxib Vioxx Pulled from market, September ’04

The Food and Drug Administration (FDA) today requested Pfizer recall arthritis drug Bextra (valdexocib) and change the warning label on Celebrex (celecoxib). The withdrawal is the result of several studies calling into question the risks of this class of drug, including heart damage from long-term use, gastroinestinal bleeding, and a life-threatening skin condition.

Both drugs are non-steroidal anti-inflammatory drugs; the FDA is asking makers of all drugs in this class to revise their warning labels to include the same boxed warning as Celebrex. The withdrawal and warnings comes on the heels of the Vioxx recall in September, 2004.

Articles

Pfizer pulls Bextra off the market: FDA cites health concerns in asking drugmaker to withdraw arthritis painkiller. CNNMoney.com. April 7, 2005: 10:36 AM EDT
“The FDA cited inadequate information on possible heart risks from long-term use of the drug as well as “life-threatening” skin reactions, including deaths.”
Doctors Back Bextra Ban. Forbes. April 7, 2005: 1:35 PM ET
“Analysts and doctors agreed that since Bextra is being pulled Merck’s (nyse: MRK – news – people ) similar Vioxx, which was withdrawn in September, is unlikely to ever return to the market.”
Pfizer Halts Bextra Sales in U.S., Europe. Reuters. April 7, 2005 01:52 PM ET .

“Pfizer Inc. on Thursday agreed to suspend sales of its arthritis drug Bextra after U.S. and European regulators said the risk of serious side effects, including a potentially fatal skin allergy, outweigh the benefits.

“The U.S. Food and Drug Administration also asked Pfizer to add a black box warning — the strongest possible — to the label for its painkiller Celebrex.”

Non-selective NSAIDs

Chemical Name Brand Name
Diclofenac Cataflam, Voltaren, Arthrotec (combination with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen ** Motrin, Motrin IB, Motrin Migraine Pain, Advil, Advil Migraine Liqui-gels, Ibu-Tab 200, Medipren, Cap-Profen, Tab-Profen, Profen, Ibuprohm, Children’s Elixsure *, Vicoprofen (combination with hydrocodone), Combunox (combination with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethegan
Ketoprofen ** Oruvail, Orudis, Actron
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen ** Aleve, Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Salsalate Disalcid
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

* There are many OTC Combinations with ibuprofen: Advil Cold And Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprohm Cold and Sinus, Sine-Aid IB, Children’s Motrin Cold.

** There are over-the-counter versions of these prescription medications.

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