For free legal consultation regarding Ibuprofen, click here.
Today
Show Interview of the Kiss Family  
Children's Advil / Motrin (Ibuprofen)
Another
little girl injured by Children's Motrin causing SJS /
TEN
Children's Motrin
(07/08/05 - RALEIGH) — A local toddler
is recovering from what doctors believe was a severe
reaction to a popular children's medicine.
The little girl was diagnosed with Stevens-Johnson
Syndrome. It's an extreme reaction to a wide range of
medicine. In this case, doctors think it was Children's
Motrin. It caused her skin to literally start shedding,
and it struck without warning.
Maliyah, 2, has made an incredible recovery from a
terrifying illness that could have killed her. Four
weeks ago, she was at the NC Jaycee Burn Center in
Chapel Hill, struggling to survive Stevens-Johnson
Syndrome.
Children & Stevens-Johnson Syndrome
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Stevens-Johnson Syndrome
by William L. Weston, M.D.
Professor of Dermatology
University of Colorado Health Sciences Center
SJS, or Stevens-Johnson Syndrome, is an abrupt,
severe injury to the mouth, eyes, and skin, where
large sheets of mucosa or skin are destroyed and
then shed. The occurrence of SJS is uncommon.
For most individuals, SJS is the result of a drug
reaction. Sulfa drugs, seizure drugs, and analgesics
(pain relievers) are the most common medicines to
cause SJS; however, a large number of drugs can
cause it. In a few individuals, infections, such as
pneumonias caused by Mycoplasma, may cause SJS.
SJS mostly occurs in toddlers and in young
children.r
Most physicians diagnose SJS from the involvement of
the mouth and the eyes, plus the appearance of skin
lesions. Sometimes, a skin biopsy may be needed to
distinguish SJS from other conditions, such as
pemphigus, which is another blistering condition.
There
is not a specific treatment for SJS at
the time of an attack. Treatment for SJS
consists of replacing fluids, calories,
and salts, and then treating the skin
as if it was a burn. If a drug is suspected
of causing SJS, it should be stopped.
SJS is a severe, life-threatening condition,
and the best treatment occurs when the
child is admitted to a hospital with a
pediatric burn unit or a pediatric intensive
care unit
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Citizen
Petition Calls For
Warning Labels On Ibuprofen
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WASHINGTON -- A citizen
petition is being filed Tuesday in Washington
urging the government to require warning labels
on ibuprofen products.
The petition says the products can cause two
life-threatening reactions. Stevens Johnson
syndrome is a severe disorder of mucous
membranes, while toxic epidermal necrolysis is a
skin disorder characterized by a blistering and
peeling of the top layer of skin.
The action was prompted by a New Jersey woman
who said her 3-year-old daughter died in March
2003 after taking Children's Advil. Darlene Kiss
said her daughter, Heather, reacted to the drug
and developed both Stevens Johnson syndrome and
toxic epidermal necrolysis.
Separately, the Kiss family has filed a wrongful
death suit against Wyeth Consumer Healthcare,
the maker of Advil, for not warning them about
possible drug risks. The suit says the company
provides this warning in Europe.
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Health News Article
Reuters.co.uk
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WASHINGTON (Reuters
Health) - ......
The group filed a petition with the US Food and Drug
Administration asking it to strengthen labels on Advil and other
ibuprofen-based drugs to warn doctors and consumers that the
widely sold products can increase the risk of skin reactions,
including serious conditions like Steven Johnson Syndrome (SJS)
and toxic epidermal necrolysis (TEN).
SJS occurs in approximately four in every one million ibuprofen
users. Those who continue taking the drug can develop TEN, which
causes severe skin sloughing and is fatal in nearly one third of
affected patients.
"All we're asking for is a few sentences on the box. We're not
asking that the drug be withdrawn," said Dr. Michael Nicar, a
toxicologist from Baylor University Medical Center in Dallas.
Nicar signed the petition along with three other physicians, all
of whom have acted as expert witnesses in lawsuits against
ibuprofen manufacturers. Three families that are suing drug
companies, alleging that their children were injured or killed
after using ibuprofen, also signed the document.
The petition also calls on the FDA to launch an investigation
into allegations that ibuprofen manufacturers withheld
information on the risks of dangerous reactions to their
products.
Drug reactions cause an estimated 5000 hospitalizations and tens
of thousands of outpatient visits for SJS, TEN, and related
disorders each year, according to a study published last month
in the journal Pharmacoepidemiology and Drug Safety.
Approximately half of all SJS cases are caused by viruses, while
the rest are caused by a variety of drugs, including
anticonvulsants and antibiotics.
Ibuprofen does not generally cause the disorder in adults but
can in children, said Dr. Roger E. Salisbury, a professor of
surgery at Westchester Medical Center in Valhalla, New York, who
also signed the petition.
"There are a lot of physicians who are not even familiar with
this association," he said. Doctors and patients should know to
stop the drugs immediately if a rash appears, he added.
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Group Calls for Ibuprofen
Warnings
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“We’re merely asking the FDA to look at this and tighten up the
warnings,” says Roger E. Salisbury, MD, chief of plastic surgery
at Westchester Medical Center in Valhalla, N.Y., who signed the
petition along with three other doctors and three families of
children who were allegedly injured or who died after taking
ibuprofen.
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Painkiller Problem
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The federal government
is on the spot tonight about a popular drug used to treat
children's fever. Health specialist Marilyn Mitzel has more
about this painkiller problem?
WSVN -- It's a drug millions of parents turn to each year to
make their children feel better.
But tonight, there's a call for more warnings about the
potential dangers of Ibuprofen.
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Family
Petitions FDA After
Death of
Toddler
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A family, whose toddler
died, is petitioning the Food and Drug Administration to add a
new warning to drugs containing Ibuprofen, the active ingredient
in Advil, Motrin and Nuprin.
"We believe that these companies have withheld critical safety
information for both physicians and American consumers," says
Mark Mills, medical researcher.
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Critics say
fever reducer
caused
death in children |
Washington D.C., Feb. 15 - Heather Kiss was three-years-old, the perfect
child, say her parents, until a simple fever became something much
worse.
They believe the Children's Advil they gave her to bring the fever down
caused a rare disorder that leaves its victims with rashes and peeling
skin as if they had been severely burned. "Her rash was blisters that
were three inches in diameter from the top of her head down to her
toes."
Heather's mother, Darlene Kiss adds, "They tried to take her fever, her
temperature and parts of her ear, the skin, would just slough off in the
nurse's hands."
Within a few days, Heather was dead.
Her parents have joined in a petition urging that Ibuprofen sold over
the counter as Advil and Children's Motrin be required to carry a
warning label so parents can know what danger signs to watch for.
Medical researcher Mark Mills says, "The reason why it's important, this disease
can be halted and progressed before it kills."
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CALLS FOR
WARNING LABEL ON
IBUPROFEN
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WASHINGTON (AP) -- A
citizen petition is being filed today in Washington urging the
government to require warning labels on Ibuprofen products.
The petition says the products can cause two life-threatening
reactions.
Today's action was prompted by a New Jersey woman who says her
three-year-old daughter died after taking Children's Advil.
Darlene Kiss says her daughter, Heather, reacted to the drug.
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Ibuprofen Danger
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A family whose daughter
died after she took ibuprofen is calling on the Food and Drug
Administration to add a new warning to ibuprofen products.
Heather Kiss, 3, was given children's Advil to reduce her fever.
But her parents say the drug triggered a severe reaction that
led to her death.
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Can Ibuprofen Be
Life-Threatening? |
New Media Producer:
Kerry Corum
A citizen petition is being filed Tuesday in Washington urging
the government to require warning labels on Ibuprofen products.
The petition says the products can cause two life-threatening
reactions.
Tuesday's action was prompted by a New Jersey woman who says her
three-year-old daughter died after taking Children's Advil.
Darlene Kiss says her daughter, Heather, reacted to the drug.
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Makers of
Advil sued in
wrongful
death suit
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Makers of Advil sued in
wrongful death suit
Feb 15, 2005, 1:46 PM ET by Keith McDuffee
The parents of three-year-old Heather Kiss of New Jersey filed a
lawsuit against the makers of over the counter Children’s Advil
after their daughter died from Stevens-Johnson Syndrome and
Toxic Epidermal Necrolysis, conditions that are typically caused
by an adverse reaction to a drug or virus. The parents believe
the conditions were a result of their child taking the
over-the-counter drug
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A
caution for Children 's Advil
-
February 14, 2005
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A disturbing story from New Jersey
involving another popular painkiller began two years ago when
three-year-old Heather Kiss was given the over-the-counter
medicine Children's Advil.
A doctor recommended the drug to her parents and they gave it to
their daughter in a few separate doses.
Advil is one brand name for the drug Ibuprofen, which doctors
say can trigger problems.
Dr. Michael Cohen of the Institute for Safe Medication Practices
said, "Aspirin and Ibuprofen are known to cause bleeding in the
stomach. For example, if you take too much or are sensitive to
it and there are also allergic reactions to those drugs."
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Children's Advil Warning |
A popular children's drug is being blamed for a little girl's death. Her
parents are warning others about the dangers, and taking the drug's
maker to court. 7's Janet Wu with the story.
Her name was Heather. She was just three years old and perfect in her
parents' eyes. But everything changed after a simple fever two years
ago. Under a doctor's advice, Heather's parents - Andrew and Darlene -
gave her a few separate doses of the over-the-counter medicine
Children's Advil.
Advil is one brand name for the drug ibuprofen which doctors say can
trigger problems.
Dr. Michael Cohen, Institute for Safe Medication Practices
"Aspirin and ibuprofen are known to cause bleeding in the stomach. For
example, if you take too much or are sensitive to it and there are also
allergic reactions to those drugs."
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Stevens-Johnson Syndrome |
Pharmacoepidemiol
Drug Saf. 2005 Jan 11;
Utilization
of hospital and outpatient care for adverse
cutaneous reactions to medications.
Stern
RS.
Department
of Dermatology, Beth Israel Deaconess Medical
Center, Harvard Medical School, Boston, MA,
USA.
PURPOSE:
To quantify hospitalizations, visits to office
based physicians, hospital clinics and emergency
departments with primary diagnoses of skin
conditions that are often due to drug reaction.
METHODS: I analyzed data from the National
Hospital Discharge Summary (1997-2001), National
Ambulatory Care Survey (1995-2000) and National
Hospital Ambulatory Care Survey (1995-2000)
to determine the number of hospitalizations
and visits with primary diagnoses of skin conditions
that are often attributed to drugs. Using statistical
methods for surveys, I determined the demographic
characteristics of patients with these diagnoses
and compared them with patients seeking care
for other reasons. RESULTS: In the United States,
there are about 5000 hospitalizations each
year with a primary diagnosis of erythema multiform,
Stevens-Johnson Syndrome or Toxic Epidermal
Necrolysis, of which 35% are specifically ascribed
to drugs. Annually, there are more than 100
000 outpatient visits for these diagnoses and
about two million visits for immediate hypersensitivity
reactions that may be due to drugs. Outpatient
visits for drug eruptions and drug allergies
that include a skin component exceed 500 000
annually. CONCLUSIONS: Skin conditions often
attributed to drugs are frequent reasons for
hospitalization and physician visits. Optimal
care of the individual patients with these
conditions requires careful attention to drugs
as a possible cause. Copyright (c) 2005 John
Wiley & Sons, Ltd.
PMID:
15645516 [PubMed - as supplied by publisher] |
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Ibuprofen
News
Two new bills would expand state's drug oversight
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Assembly Majority Leader
Dario Frommer, D-Glendale, said so many questions have been
raised about the U.S. Food and Drug Administration's ability to
ensure drug safety ``that California needs to have a second set
of eyes in looking at these medications.''
State law already allows for pulling drugs from store shelves if
there is a public-safety threat or false labeling. But two bills
introduced this week by Frommer and the Assembly Health
Committee chair, Wilma Chan, D-Oakland, would greatly expand the
state's oversight.
One bill would establish the California Drug Safety Watch,
including a hotline for consumers to report any bad reactions to
drugs in a database that would be made available to the public.
The second would require drug makers to supply the state with
the results of all studies on the safety and effectiveness of
drugs being marketed in California..........
The Mercury News last week
reported the fatal and disabling reactions of some children to Children's Motrin, including the death of 9-year-old Kaitlyn Langstaff of Saratoga.
And the FDA has been under fire for not pushing earlier to have
Vioxx taken off the market because of an increased risk of heart attacks and strokes.
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Wrongful Death Lawsuit Filed
against Makers of
Children's
Advil
on Behalf of Heather Kiss |
In their lawsuit, Darlene and Andrew Kiss accuse Wyeth of wrongful
death, negligence, defective design, breach of express warranty, breach
of implied warranty, and failure to warn consumers and doctors of the
potential health risks of taking over the counter Children's Advil,
specifically the risk of developing two life-threatening and fatal
cutaneous disorders -- Stevens-Johnson Syndrome (SJS) and Toxic
Epidermal Necrolysis (TEN) -- which are typically caused by an adverse
reaction to a drug or virus.
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Lawsuits prompt closer look at rare disease linked to ibuprofen
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Dr. Roy Levin, who said
he was unaware of the association between Children's Motrin and
Stevens Johnson Syndrome until he treated Kaitlyn Langstaff,
said of the drug companies: "They have to warn people who think
it's as safe as getting M&Ms."
And Darlene Kiss, Heather's mother, said she believes parents
have the right to know that medicines used routinely for
children have the potential for such catastrophic consequences.
"Even if it's a verbal warning from the doctor, it would make
you think," said Kiss, who named her baby daughter Heidi Rose in
honor of Heather Rose, who died March 17, 2003. Kiss has hired
an attorney but has not filed suit.
A number of other drugs can cause Stevens Johnson Syndrome, and
some of them - including prescription-strength ibuprofen - carry
warnings about the risk of the severe skin reactions. Though the
FDA has acknowledged that ibuprofen can cause the syndrome, the
government has not ordered pharmaceutical companies to mention
the disease that killed Heather Rose and Kaitlyn on
over-the-counter ibuprofen labeling, saying the risk of harm is
too low.
Space on drug labels should be devoted to more common adverse
reactions, such as gastrointestinal bleeding and kidney
problems, the agency says.
"There is only so much you can put on a label," the FDA said in
a statement to the Mercury News. "We already know that the
longer the labels, the less someone is going to read them."
There are an estimated one to six cases of Stevens Johnson
Syndrome per million people in the United States each year, due
to drug reactions as well as other causes. The FDA told the
Mercury News it has received about 150 reports of the syndrome
in patients who had used ibuprofen over the years. The agency
would not say how common a side effect needs to be to trigger a
specific warning on the label.
However, Pfizer announced last month that it will add a
"black-box" warning - the strongest a drug can carry - to the
label of its prescription painkiller Bextra after 87 people
taking the drug developed severe skin reactions, including
Stevens Johnson Syndrome and toxic epidermal necrolysis, and
four died. Bextra is part of the same broad class of drugs -
known as non-steroidal anti-inflammatory drugs or NSAIDs - as
ibuprofen
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| Ibuprofen
/ Children's Motrin Advil Related Information |
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
| Stevens-Johnson syndrome treatments and Related Information |
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
Acute and Chronic Respiratory Complications of Toxic Epidermal Necrolysis., PubMed, National Library of Medicine, J Burn Care Rehabilitation 1996 May-Jun;17(3):237-40, R.A. McIvor, MD; J. Zaidi, MD; W. J. Peters, MD; R.H.Hyland, MD. Division of Respirology, University of Toronto, and the Ross Tilley Burn Centre, Wellesley Hospital, Toronto, Ontario, Canada.
Bronchiolitis obliterans in children with Stevens-Johnson syndrome: follow-up with high resolution CT., PubMed, National Library of Medicine, Pediatrics Radiology 1996;26(1):22-5, M.J. Kim and K.Y. Lee. Department of Diagnostic Radiology, Severance Hospital, 134 Seodaemoon-gu, Shinchon-dong, Seoul 120-752, Korea.
Drug-associated acute-onset vanishing bile duct and Stevens-Johnson syndromes in a child. PubMed, Srivastava M, Perez-Atayde A, Jonas MM. Combined Program in Gastroenterology, Department of Medicine, Children's Hospital, Boston, Massachusetts, USA., Gastroenterology. 1998 Sep;115(3):743-6.PMID: 9721172.
Esophageal Involvement in Stevens-Johnson Syndrome., PubMed, National Library of Medicine, Endoscopy 2001 Jun;33(6):550-3, Lamireau T, Leaute-Labreze C, Le Bail B, Taieb A., Division of Pediatric Gastroenterology, Children 's Hospital, Bordeaux, France. thierry.lamireau@chu-bordeaux.fr. Division of Pediatric Dermatology, Children's Hospital, Bordeaux, France, Laboratory of Pathology, Pellegrin's Hospital, Bordeaux, France.
Stevens-Johnson Syndrome and Cholestatic Hepatitis., PubMed, National Library of Medicine, Digestive Diseases and Sciences, Vol. 46, No. 11 (November 2001):2385-8, Michael S. Morelli, MD and Francis X. O'Brien, MD. Department of Internal Medicine, Section of General Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, USA.
Intravenous ulinastatin therapy for Stevens-Johnson syndrome and toxic epidermal necrolysis in pediatric patients. Three case reports., PubMed, National Library of Medicine, Int Arch Allergy Immunol 2002 Jan;127(1):89-94, Inamo Y, Okubo T, Wada M, Fuchigami S, Hashimoto K, Fuchigami T, Takahashi S, Sawada S, Harada K, Department of General Pediatrics, Nihon University Nerima-Hikarigaoka Hospital, Nihon University School of Medicine, Tokyo, Japan. y-inamo@pb3.so-net.ne.jp
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