NEW DRUG WARNINGS - http://www.dayproinjuries.com/Drug_Reference_.htm

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Arthritis

Drug May Cause Severe Reaction, WebMDHealth.com, November 15, 2002,

by Lisa Habib WebMD

Medical News. Since Bextra was introduced in March, Pharmacia,

Bextra's manufacturer, has reported to the FDA serious and

life-threatening skin and hypersensitivity reactions to the drug. These

include cases of Stevens-Johnson syndrome, a rare and potentially

deadly disorder characterized by inflammation of the mucous membranes

of the mouth, throat, genitals, intestinal tract, and membrane lining

the eyelids, which can lead to lesions and blisters.

FDA, PHARMACIA UPDATE BEXTRA LABEL WITH NEW WARNINGS

DallasNews.com

| Dallas-Fort Worth | Nation

The Food and Drug Administration has about 20 reports of serious

reactions – including the skin diseases Stevens-Johnson syndrome, toxic

epidermal necrolysis and exfoliative dermatitis, as well as allergic

reactions – among Bextra users since sales began in March.

 

 

 

 

Celebrex Related Information

 

 

 

 

Friedman

B, Orlet HK, Still JM, Law E.

Toxic epidermal necrolysis due to administration of celecoxib

(Celebrex). South Med J. 2002 Oct;95(10):1213-4.PMID: 12425513 [PubMed

- indexed for MEDLINE]

Celebrex Web Site, Pharmacia Corp.

Celebrex Consumer Information, US

Food and Drug Administration, Center for Drug Evaluation and Research

You and A: Arthritis Drugs,

Washingtonpost.com, September 4, 2001

Risk of Cardiovascular Events Associated with Selective COX-2

Inhibitors (abstract), Journal of the

American Medical Association, Vol. 286 No. 8, August 22/29, 2001

Safety

of Arthritis Drugs in Question, WebMD, July

10, 2001

FDA Panel Rejects Celebrex's Marketing Request, USATODAY.com, February 8, 2001

Warning

Letter to Pharmacia Corp. from US Food and Drug Administration, re:

Celebrex (Celecoxib) Capsules (PDF), February

1, 2001

Marketing Rx, A NewsHour with Jim

Leher Transcript, December 26, 2000

FDA Approves Celebrex for New Indication, US Food and Drug Administration, December 23, 1999

Approval Package: Celebrex (Celecoxib) Capsules,

US Food and Drug Administration, Center for Drug Evaluation and

Research, Application No. 21-156 & 20998/S007, Approval Date:

December 23, 1999

FDA Approves First Drug in New Class of Painkillers, CNN.com, December 31, 1998

FDA Approves Celebrex for Arthritis,

US Food and Drug Administration, December 31, 1998

Approval

Package: Celebrex (Celecoxib) Capsules,

US Food and Drug Administration, Center for Drug Evaluation and

Research, Application No. 20-998, Approval December 31, 1998

 

 

 

 

Children's Motrin / Advil Related Information

 

 

 

 

 

Parents

of stricken girl sue makers of Children's Motrin

SARATOGA PAIR CLAIM MEDICINE LEFT 9-YEAR-OLD UNABLE TO SEE,

SPEAK, EAT

By Linda Goldston Mercury News

The parents of a 9-year-old Saratoga girl

have sued the makers of Children's Motrin,

claiming

the flu and pain medication caused the extreme allergic reaction that

left their daughter, Kaitlyn Langstaff, unable to see, speak or eat.

The

lawsuit filed in U.S. District Court in San Jose also alleges that the

manufacturer of the drug failed to adequately test it for

over-the-counter use with children and failed to warn the public of

potentially fatal reactions to Children's Motrin.

 

 

Children's

Motrin (Ibuprofen) Oral Suspension, Junior Strength Motrin Chewable

Tablet, Junior Strength Motrin Tablets & Drops, Company: McNeil

Consumer Products Company

Application

No.: 20-516/S4, 20-601/S2, 20-602/S3 & 20-603/S2, U.S. Food and

Drug Administration, Center for Drug Evaluation and Research, Approval

August 13, 1999

 

 

 

 

Daypro Related Information

 

 

 

 

Clinical

aspects of skin reactions to NSAIDs.,

PubMed, National Library of Medicine, Scand J Rheumatology Suppl

1987;65:131-4, J.C. Roujeau. Service de Dermatologie et Departement d'

Immunologie, Hospital Henri Mondor, Universite Paris XII, Creteil,

France.

 

 

Oxaprozin-induced

pseudoporphyria., PubMed, National Library of Medicine, Arch

Dermatology 1996 Dec;132(12):1519-20, Ingrish G, Rietschel RL.

 

 

Case

report: oxaprozin and fatal toxic epidermal necrolysis.,

PubMed, National Library of Medicine, J Burn Care Rehabilitation 1998

Jul-Aug;19(4):321-3, Chester N. Paul, MD; David W. Voigt, MD; Kurt E.

Clyne, MD; Sean L. Hansen, BS. Burn and Wound Center, Saint Elizabeth

Community Health Center, Lincoln, Nebraska 68510, USA.

 

 

A

case of Stevens-Johnson syndrome associated with oxaprozin therapy.,

PubMed, National Library of Medicine, The Journal of Rheumatology 1998

Oct;25(10):2026-8, Mary J. Bell, MD, FRCPC, Assistant Professor,

Division of Rheumatology, Faculty of Medicine, Research Scientist,

Arthritis Community Research and Evaluation Unit and Laila D. Bishara,

MD, Resident in General Internal Medicine, University of Toronto.

Department of Medicine, Sunnybrook Health Science Centre, University of

Toronto, Ontario, Canada.

 

 

Toxic

epidermal necrolysis following treatment with oxaprozin., PubMed,

National Library of Medicine, International Journal of Dermatology 1999

Mar;38(3):233-4, Carucci JA, Cohen DE.

 

 

 

 

All Cox-2 Drugs Related Information

 

 

 

 

 

 

 

 

Arthritis Drugs Put a Hurt on Merck and Pfizer

 

 

 

Februa

The latest stock market action for both stocks appears to be a reaction

to two articles published on line ahead of their inclusion in the Oct.

21 edition of the New England Journal of Medicine. In one editorial,

Dr. Garret A. FitzGerald urged the Food and Drug Administration to

examine all of the COX-2 drugs. FitzGerald is a medical researcher at

the Institute for Translational Medicine and Therapeutics at the

University of Pennsylvania. "We must remember that the absence of

evidence is not the evidence of absence," said FitzGerald, who has

received consulting fees and research support from Merck.

 

 

 

 

 

 

 

 

 

 

 

Another

New England Journal of Medicine article was written by a cardiologist,

Dr. Eric J. Topol of the Cleveland Clinic, who has been a long-time

critic of Vioxx. He called for a congressional investigation of the

Vioxx approval process and the relationship between Merck and the Food

and Drug Administration. "The senior executives at Merck and the

leadership at the FDA share responsibility for not having taken

appropriate action and not recognizing that they are accountable for

public health," he charged.

 

 

 

 

 

 

 

 

Safety

of All Cox-2 Drugs Questioned

 

 

 

 

 

 

 

 

 

 

Februa

FRIDAY, Oct. 8 (HealthDayNews) -- A week after drug giant Merck &

Co. withdrew its arthritis drug Vioxx from the market, doubts are being

raised about the safety of the two other approved medications in this

class, Bextra and Celebrex.

 

In an article released Thursday by

the New England Journal of Medicine, an expert with a long history of

research in the cox-2 inhibitor class of medications said

cardiovascular problems seen with Vioxx may yet surface with the other

two drugs.

 

The problem, said Dr. Garrett A. FitzGerald, is that

all cox-2 inhibitors suppress the production of a heart-protecting fat

called prostaglandin I2.

 

"Vioxx, Celebrex and Bextra all have

the same effect on this biochemical system. Therefore, until proven

otherwise, evidence would suggest that this mechanism would involve all

drugs in this class," explained FitzGerald, who is chairman of

pharmacology at the University of Pennsylvania's Institute of

Translational Medicine and Therapeutics.