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
PHARMACIA UPDATE BEXTRA LABEL WITH NEW WARNINGS
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
Web Site, Pharmacia Corp.
Consumer Information, US Food and Drug
Administration, Center for Drug Evaluation and Research
and A: Arthritis Drugs, Washingtonpost.com,
September 4, 2001
of Arthritis Drugs in Question, WebMD,
July 10, 2001
- FDA Panel Rejects Celebrex's Marketing Request,
USATODAY.com, February 8, 2001
Letter to Pharmacia Corp. from US Food and Drug Administration,
re: Celebrex (Celecoxib) Capsules (PDF),
February 1, 2001
Rx, A NewsHour with Jim Leher Transcript,
December 26, 2000
Approves Celebrex for New Indication,
US Food and Drug Administration, December 23, 1999
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
Approves First Drug in New Class of Painkillers, CNN.com, December 31, 1998
Approves Celebrex for Arthritis, US
Food and Drug Administration, December 31, 1998
Package: Celebrex (Celecoxib) Capsules, US Food and Drug Administration, Center for Drug Evaluation and
Research, Application No. 20-998, Approval Date: December 31,
| Children's Motrin
/ Advil Related Information
of stricken girl sue makers of Children's Motrin
PAIR CLAIM MEDICINE LEFT 9-YEAR-OLD UNABLE TO SEE, SPEAK,
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.
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
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.
pseudoporphyria., PubMed, National Library of Medicine, Arch
Dermatology 1996 Dec;132(12):1519-20, Ingrish G, Rietschel RL.
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.
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.
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.
Cox-2 Drugs Related Information
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.
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.
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.
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
Fix No. 4:
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.
look inside the FDA, its recent record, and the debate over
whether our nation's drug safety system is broken.
FAQs and links for consumers.
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.
drug monitoring system probed
(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.
To Examine How It Monitors Drugs
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.
Drugs Need a Longer Look
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.
Promises To Strengthen Drug Reviews
majority of FDA scientists feel agency does poor job of monitoring
drugs on market
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
Worries About Drug Safety
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.
Union and another nonprofit, the Health Improvement Institute,
released rankings of the 20 health-information sites
that draw the most traffic on the Web.
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
WebMD Corp., of Elmwood Park, N.J., owns two of the other top
sites: WebMD Health and MedScape. Rounding out
"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, 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.
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
-- 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
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
syndrome plus toxic hepatitis due to ibuprofen, PubMed, National
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Sternlieb P, Robinson RM. Nassau Hospital, Mineola, New
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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.
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