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Bextra Related Information
  • Arthritis Drug May Cause Severe Reaction, WebMDHealth.com, November 15, 2002, bLisa 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.
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
  • 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 Date: December 31, 1998
Children's  Motrin / Advil Related Information
  • Parents of stricken girl sue makers of Children's Motrin

       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 Date: 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 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 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.

Drug Related Information
FDA Clears Genetic Test That Advances Personalized Medicine Today, FDA cleared for marketing a new blood test that will help doctors make personalized drug treatment decisions for some patients. The Invader UGT1A1 Molecular Assay detects variations in a gene that affects how certain drugs are broken down and cleared by the body. Doctors can use this information to help determine the right drug dosage for individual patients, and minimize harmful drug reactions.

FDA Fix No. 4:

Government-Funded Studies  Studies conducted by pharmaceutical firms are more likely to show success than those funded by the National Institutes of Health or other outside institutions..."We need to ensure there is a benefit, not a liability, that we are giving to those seniors," says Raymond Woosley, vice president for health sciences at the University of Arizona.

Dangerous Prescription

Watch the

Full Program Online 

A look inside the FDA, its recent record, and the debate over whether our nation's drug safety system is broken.

Plus, FAQs and links for consumers.

A biostatistician, Michael Elashoff was a drug reviewer for the FDA from 1995 to 2000. Elashoff says he found himself marginalized at the FDA after he voiced his concerns about a new flu drug called Relenza. In this interview, Elashoff speaks out about the culture of the FDA's drug approval process and why he felt Relenza should not have been put on the market. This interview was conducted on Feb. 19, 2003.

FDA  --  U.S. Department of
Health & Human Services

Information about the Products the FDA Regulates

FDA's counsel accused of being too close to drug industry

Daniel Troy, chief counsel to the US Food and Drug Administration, is under fire for inviting drug companies to inform him of lawsuits against them so the FDA could help in their defense.  Jeanne Lenzer New York  BMJ 2004;329:189 (24 July), doi:10.1136/bmj.329.7459.189;  Produced by BMJ Publishing Group Ltd of the BMA, assisted by Stanford University's HighWire Press.

 FDA drug monitoring system probed

WASHINGTON (CBS.MW)-- The U.S Food and Drug Administration said on Friday that it has asked the Institute of Medicine to review how FDA monitors drugs after they hit the market.



 FDA To Examine How It Monitors Drugs

The agency has come under fire for its handling of Merck's (nyse: MRK - news - people ) withdrawn painkiller Vioxx and for failing to warn that antidepressants raised the risk of suicidal behavior in children and teens. Agency reviewers have complained that their warnings about potential problems were ignored.

Now the FDA is saying it will work to include all opinions from staff reviewers in evaluating drug data. It also asked an independent group, the Institute of Medicine, to review the way it monitors safety risks of drugs in the market and evaluate its role in the health care system.

 Why Drugs Need a Longer Look

The Vioxx fiasco signals the need for a returned FDA approval system, one that tracks more than short-term risks and side effects

Consumers can be excused if the Cox 2 painkiller debacle has left them scratching their heads. First, Merck (MRK) pulled its Vioxx off the market after a study confirmed suspicions that it was linked to an increased risk of heart attack and stroke. Then, after rival Pfizer (PFE) announced its Cox 2 Bextra drug also showed a higher risk of heart attack and stroke in patients who had just undergone a certain kind of heart surgery.


 FDA Promises To Strengthen Drug Reviews

 Bextra, Vioxx, Celebrex

The move by the FDA follows the late September withdrawal by Merck & Co. of its popular Vioxx drug for acute pain and inflammation because of the increased risk of heart attacks and strokes in those taking the prescription medicine. The federal agency also said it would review other classes of drugs on the market, including the popular Cox-2 inhibitor drugs, such as Pfizer Inc.'s Celebrex and Bextra drugs, which are used for treating the pain and inflammation associated with arthritis and some other medical conditions. A Canadian newspaper reported this week that 14 deaths were linked to patients who were taking Celebrex, but Pfizer and Canadian health officials denied that the deaths were connected to the use of the drug. The Reuters news agency reported Friday that a Canadian law firm filed a class-action lawsuit last month against Pfizer for both its Celebrex and Bextra drugs, alleging that they caused cardiovascular side effects.

Strong majority of FDA scientists feel agency does poor job of monitoring drugs on market

WASHINGTON_About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
AP Alert - Michigan


New Worries About Drug Safety


NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.

Health Related Information

Consumers Union and another nonprofit, the Health Improvement Institute, released rankings of the 20 health-information sites that draw the most traffic on the Web. 

Six sites drew a rating of "excellent," in part because they included unbiased, peer-reviewed articles written by health professionals, according to Consumer Health WebWatch, the name given to the joint venture.

Among the top-rated sites, two that are nonprofit and advertising-free are a great place to start any search for reliable health information.

One is the outstanding Web site of the National Institutes of Health (www.nih.gov. The other is KidsHealth (www.kidshealth.org), a creation of the Nemours Foundation's Center for Children's Health Media.

WebMD Corp., of Elmwood Park, N.J., owns two of the other top sites: WebMD Health and MedScape. Rounding out the "excellent" tier are www.MayoClinic.com, a commercial site despite its foundation ownership, and www.MedicineNet.com.

At the other end of the spectrum was www.QualityHealth.com, the only top-20 site rated below "good

NSAIDs Related Information


NSAIDs, also called non-steroidal anti-inflammatory drugs, are medications used to reduce pain and swelling. About 20 are available with a prescription, and three are available over-the- counter. These include ibuprofen, naproxen and ketoprofen. The only difference between the over-the- counter and prescription versions is that the latter is available in higher dosages. Some examples of NSAIDs are Advil, Motrin, Aleve, Bayer, and Excedrin. NSAIDs can also be found in cold medications like Advil Cold and Sinus, Dimetapp Sinus, Motrin IB Sinus and Aleve Cold and Sinus. Acetaminophen, also sold as Tylenol, is not a NSAIDs.
Naprosyn Related Information
Stevens-Johnson syndrome treatments and Related Information

Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions
With more than 40 percent of Americans taking at least one prescription drug (2004 CDC report), the potential for the deadly adverse drug reaction known as Stevens Johnson Syndrome (SJS) is increasing.

Described in many drug warning inserts as a "serious skin condition," SJS is actually a devastating reaction affecting the skin and mucous membranes, causing severe burning, blistering and sloughing of involved tissue. SJS commonly causes blindness and results in death in 10 to 30 percent of the cases.

An under-reported and under-recognized condition, people develop SJS from commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such as adult and children ibuprofen products. Because many physicians and emergency facilities are not familiar with the symptoms, treatment is frequently delayed, further exacerbating the condition.

To recognize SJS in its earliest stage, the SJS foundation urges patients and physicians to watch for the following symptoms when taking medications:

-- Persistent fever
-- Burning or blistering of the mucous membranes, i.e.: eyes, ears, mouth, nose, genital area.
-- Rash, blisters or red splotches on skin
-- Flu-like symptoms
-- History of a reaction to prescribed drugs or over-the-counter medications.

In one estimate, SJS is reported to effect three to eight people per million per year in the U.S. However, the frequency could be much higher since only one percent of adverse drug reactions is reported, according to the Food and Drug Administration.

"SJS is not as rare as we are led to believe," said Jean McCawley, president of the SJS Foundation. "As prescription drug use increases, we are being contacted by increasing numbers of people. During the winter months, we learn of 15 new cases a week, and that's only people with Internet access."

About SJS Foundation

Founded in 1995, the Stevens Johnson Syndrome Foundation (Julie Foundation for allergic drug reactions) is a non-profit organization that provides information and support for victims, educates the medical community and encourages research in preventing adverse drug reactions. More information is available at www.sjsupport.org

  • New Treatment for Acute Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
    Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are moderate and severe variations of the same adverse reaction (usually to drugs or mycoplasma pneumonia) which result in blistering and sloughing of skin and mucosal membranes, and carry a high risk of mortality
  • Stevens-Johnson syndrome plus toxic hepatitis due to ibuprofen, PubMed, National Library of Medicine, New York State Journal of Medicine July;78(8):1239-43, Sternlieb P, Robinson RM.  Nassau Hospital, Mineola, New York
  • Introital adenosis associated with Stevens-Johnson syndrome, PubMed, National Library of Medicine, Obstet Gynecol 1985 Jul;66(1):143-5, Marquette GP, Su B, Woodruff JD.
    A 23-year-old woman presented with vulvar pain and dyspareunia 1.5 years after a Stevens-Johnson syndrome. A red friable lesion was identified at the vestibule and lower third of the vagina. The histologic diagnosis was adenosis with a tubal glandular epithelium. The possible histogenesis of this lesion is discussed with a review of the embryology of the lower genital tract.
  • Rehabilitative considerations for patients with severe Stevens-Johnson syndrome or toxic epidermal necrolysis. A case report.  PubMed, National Library of Medicine, J Burn Care Rehabil 1989 Mar-Apr;10(2):167-71, K. McDonald, PT, B. Johnson, PT, J.K. Prasad, MD, and P. D. Thomas, PhD.  University of Michigan Medical Center, Physical Therapy Division, Ann Arbor 48109-0046.
  • Vitamin A in Stevens-Johnson Syndrome, PubMed, National Library of Medicine, Ann Ophthalmol 1989 Jun;21(6):209-10, Singer L, Brook U, Romem M, Fried D., Department of Ophthalmology, Sackler Faculty of Medicine, Tel-Aviv University, Israel.
  • Unusual manifestation of Stevens-Johnson syndrome involving the respiratory and gastrointestinal tract., PubMed, National Library of Medicine, Pediatrics 1992 Mar;89(3):429-32, Dean S. Edell, MD MPH; James J. Davidson; Andre A. Muelenaer, MD; Marc Majure, MD; Department of Pediatric Pulmonary, Duke University School of Medicine, Durham, NC.

  • Neuropathy in burn patients., PubMed, National Library of Medicine, Brain 1993 Apr;116 ( Pt 2):471-83, Sean Marquez; J. Jean E. Turley; Walter J. Peters; Department of Medicine, Division of Neurology and the Department of Surgery, Division of Plastic Surgery, Wellesley Hospital, Toronto, Canada.

  • Burn-associated peripheral polyneuropathy. A search for causative factors. PubMed, National Library of Medicine, American Journal Physical Medicine Rehabilitation 1995 Jan-Feb;74(1):28-32, Anthony J. Margherita, MD; Lawrence R. Robinson,MD; David M. Heimbach, MD; Vicki L. Fishfader,BS; Vicki A. Schneider, MS;  Dana Jones,BS.  Department of Rehabilitation Medicine, Harborview Medical Center/University of Washington School of Medicine, Seattle 98195.