WARNING - Children's Motrin Causes Severe Side Effects

[Sheri Nakken]

Warning - even parents who use homeopathy don't understand the dangers of
tylenol/calpol/paracetamol and advil/motrin/ibuprofen

Here is the latest on Ibuprofen

Motrin is a brand name for Ibuprofen (Advil, etc)

http://www.wnbc.com/health/4030295/detail.html

Lawsuit Claims Children's Motrin Causes Severe Side Effects

POSTED: 3:37 pm EST December 28, 2004
UPDATED: 5:09 pm EST December 28, 2004

LOS ANGELES -- The parents of a 7-year-old girl on Tuesday sued the makers
of Children's Motrin and several other companies that distribute the
painkiller, claiming their daughter lost her eyesight and suffered other
severe side effects after taking the medication.

The lawsuit, filed on behalf of Sabrina Brierton Johnson of Los Angeles,
seeks unspecified compensatory and punitive damages against New
Jersey-based health care giant Johnson & Johnson, subsidiary McNeil
Consumer & Specialty Pharmaceuticals, and several other firms, including
retailers Ralphs Grocery and Albertsons Inc.'s Sav-On pharmacies.

Johnson & Johnson is based in New Brunswick, N.J.

In their lawsuit, Kenneth and Joan Brierton Johnson accuse the defendants
of negligence, breach of warranty and of concealing from consumers and
doctors potential health risks of taking the flu and pain medication,
specifically the risk of developing two disorders -- Stevens-Johnson
Syndrome and Toxic Epidermal Necrolysis -- which are typically caused by an
adverse reaction to a drug or virus.

Sabrina took Children's Motrin drops on Sept. 8, 2003, after she came home
from school complaining of a fever. The girl had no known drug allergies,
according to the suit filed in Los Angeles County Superior Court.

The next morning, she woke up with a high fever and other symptoms,
including a pink coloration in her eyes and sores in her mouth. She was
hospitalized, but a day later she was blind in both eyes.

Doctors later concluded Sabrina had contracted Stevens-Johnson Syndrome
from taking Children's Motrin, according to the lawsuit. Since then,
Sabrina has undergone multiple eye surgeries.

"In the name of children everywhere, our family wants Children's Motrin
taken off the market until it carries a warning label about the risk of
Stevens-Johnson Syndrome and describes its symptoms," the girl's mother
said in a statement.

The complaint also alleges the companies knew of a connection between the
medication and the disorders from their own clinical tests dating back to
the late 1980s, and even included warnings of such risks with the drug
before it became available without a prescription.

The retailers who sold Children's Motrin and another defendant, Cardinal
Health Inc., knew or had reason to know the drug had "design flaws," the
lawsuit also claims.

Bonnie Jacobs, a spokeswoman for Fort Washington, Pa.-based McNeil, which
manufactures Children's Motrin, said McNeil and Johnson & Johnson were
aware of a report that a 7-year-old girl allegedly developed
Stevens-Johnson Syndrome after taking the medication.

"As the makers of Children's Motrin products, we are deeply concerned by
all matters relating to our products and we are investigating the
situation," Jacobs said.

She declined to discuss the case further.

Representatives of Sav-On and pharmaceutical distributor McKesson Corp.,
also a defendant, declined to comment citing company policy against
discussing pending litigation.

Messages left at the offices Dublin, Ohio-based Cardinal Health and Kroger
Co.'s Ralphs chain were not immediately returned Tuesday.

A similar lawsuit was filed against the makers of Children's Motrin in
March 2003. In that federal lawsuit, filed in San Jose, the parents of a
then 9-year-old girl alleged the medication left their daughter unable to
see, speak or eat, and accused Johnson & Johnson and McNeil of failing to
adequately test the drug for over-the-counter use and to properly warn the
public.
© 2004 by The Associated Press. All rights reserved. This material may not
be published, broadcast, rewritten or redistributed.

***********
The PubMed search
ibuprofen AND stevens AND johnson
generated 7 citations (1-7).

http://www.ncbi.nlm.nih.gov/entrez/quer ... d=Retrieve&
db=PubMed&list_uids=15289784&dopt=Abstract

1: J Pediatr. 2004 Aug;145(2):273-6.

Acute vanishing bile duct syndrome after ibuprofen therapy in a child.

Taghian M, Tran TA, Bresson-Hadni S, Menget A, Felix S, Jacquemin E.

Pediatric Unit, Vesoul Hospital, Vesoul, France.

We report the case of a 10 year-old girl who had Stevens-Johnson syndrome
and cholestasis after ibuprofen therapy. Liver histology was compatible
with vanishing bile duct syndrome. She received ursodeoxycholic acid, and
liver tests normalized within 7 months. This report confirms that ibuprofen
may induce acute vanishing bile duct syndrome.

PMID: 15289784 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=15289784
and http://www.kluweronline.com/article.asp ... 2257&PDF=1

2: Dig Dis Sci. 2001 Nov;46(11):2385-8.

Stevens-Johnson Syndrome and cholestatic hepatitis.

Morelli MS, O'Brien FX.

Department of Internal Medicine, Section of General Internal Medicine, Wake
Forest University School of Medicine, Winston-Salem, North Carolina 27157,
USA.

Stevens-Johnson Syndrome (SJS) is a rare but severe dermatological
condition that typically occurs after the ingestion of medications such as
nonsteroidal drugs, antibiotics, and anticonvulsants. Extracutaneous
manifestations of the syndrome can occur and may involve the conjunctiva,
trachea, buccal mucosa, gastrointestinal tract, and genitourinary tract.
Cholestatic liver disease, which may precede the skin manifestations of
SJS, has been reported to occur in SJS, but the medical literature has only
10 case reports describing this phenomenon (1-9). We report the case of a
19-year-old female with SJS and cholestatic liver disease. A discussion of
the underlying pathophysiology of SJS and its treatment follows.

PMID: 11713940 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/quer ... d=Retrieve&
db=PubMed&list_uids=10583942&dopt=Abstract

3: Int J Dermatol. 1999 Nov;38(11):878-9.

Pentoxyfylline in toxic epidermal necrolysis and Stevens-Johnson syndrome.

Sanclemente G, De la Roche CA, Escobar CE, Falabella R.

PMID: 10583942 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/quer ... d=Retrieve&
db=PubMed&list_uids=9865869&dopt=Abstract

4: Int J Dermatol. 1998 Nov;37(11):833-8.

Drugs causing fixed eruptions: a study of 450 cases.

Mahboob A, Haroon TS.

Department of Dermatology, King Edward Medical College/Mayo Hospital,
Lahore, Pakistan.

BACKGROUND: Drug eruptions are among the most common cutaneous disorders
encountered by the dermatologist. Some drug eruptions, although trivial,
may cause cosmetic embarrassment and fixed drug eruption (FDE) is one of
them. The diagnostic hallmark is its recurrence at previously affected sites.
OBJECTIVE: We evaluated 450 FDE patients to determine the causative drugs.
RESULTS: The ratio of men to women was 1:1.1. The main presentation of FDE
was circular hyperpigmented lesion. Less commonly FDE presented as:
nonpigmenting erythema, urticaria, dermatitis, periorbital or generalized
hypermelanosis. Occasionally FDE mimicked lichen planus, erythema
multiforme, Stevens-Johnson syndrome, paronychia, cheilitis, psoriasis,
housewife's dermatitis, melasma, lichen planus actinicus, discoid lupus
erythematosus, erythema annulare centrifugum, pemphigus vulgaris,
chilblains, pityriasis rosea and vulval or perianal hypermelanosis.
Cotrimoxazole was the most common cause of FDE. Other drugs incriminated
were tetracycline, metamizole, phenylbutazone, paracetamol, acetylsalicylic
acid, mefenamic acid, metronidazole, tinidazole, chlormezanone,
amoxycillin, ampicillin, erythromycin, belladonna, griseofulvin,
phenobarbitone, diclofenac sodium, indomethacin, ibuprofen, diflunisal,
pyrantel pamoate, clindamycin, allopurinol, orphenadrine, and albendazole.
CONCLUSIONS: Cotrimoxazole was the most common cause of FDE, whereas FDE
with diclofenac sodium, pyrantel pamoate, clindamycin, and albendazole were
reported for the first time. FDE may have multiform presentations.
PMID: 9865869 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=15289784

5: Gastroenterology. 1998 Sep;115(3):743-6.

Drug-associated acute-onset vanishing bile duct and Stevens-Johnson
syndromes in a child.

Srivastava M, Perez-Atayde A, Jonas MM.

Combined Program in Gastroenterology, Department of Medicine, Children's
Hospital, Boston, Massachusetts, USA.

Acute vanishing bile duct syndrome is a rare but established cause of
progressive cholestasis in adults, is most often drug or toxin related, and
is of unknown pathogenesis. It has not been reported previously in
children. Stevens-Johnson syndrome is a well-recognized immune
complex-mediated hypersensitivity reaction that affects all age groups, is
drug or infection induced, and has classic systemic, mucosal, and
dermatologic manifestations. A previously healthy child who developed
acute, severe, rapidly progressive
vanishing bile duct syndrome shortly after Stevens-Johnson syndrome is
described; this was temporally associated with ibuprofen use. Despite
therapy with ursodeoxycholic acid, prednisone, and then tacrolimus, her
cholestatic disease was unrelenting, with cirrhosis shown by biopsy 6
months after presentation. This case documents acute drug-related vanishing
bile duct syndrome in the pediatric age group and suggests shared immune
mechanisms in the pathogenesis of both Stevens-Johnson syndrome and
vanishing bile duct syndrome.

PMID: 9721172 [PubMed - indexed for MEDLINE]
http://jama.ama-assn.org/cgi/content/ab ... 52/11/1433

6: J Am Acad Dermatol. 1985 May;12(5 Pt 1):866-76.

Cutaneous reactions to nonsteroidal anti-inflammatory drugs. A review.

Bigby M, Stern R.

The nonsteroidal anti-inflammatory drugs are one of the most commonly
prescribed classes of drugs used in medical practice. This review discusses
the diverse cutaneous reactions associated with nonsteroidal
anti-inflammatory drugs. Adverse cutaneous reactions occur most frequently
with benoxaprofen, piroxicam, sulindac, meclofenamate sodium, zomepirac
sodium, and phenylbutazone. The most serious adverse cutaneous reactions,
Stevens-Johnson syndrome and toxic epidermal necrolysis, appear to be most
often associated with sulindac and phenylbutazone. Tolmetin and zomepirac
sodium, two structurally similar pyrrole derivatives, have been associated
with a disproportionate number of cases of anaphylactoid reactions. Among
the currently marketed nonsteroidal anti-inflammatory drugs, piroxicam
appears to have the highest rate of phototoxic reactions. This phototoxic
eruption is most often vesiculobullous.

PMID: 3159761 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=12139898

7: N Y State J Med. 1978 Jul;78(8):1239-43.

Stevens-Johnson syndrome plus toxic hepatitis due to ibuprofen.

Sternlieb P, Robinson RM.

PMID: 276660 [PubMed - indexed for MEDLINE]

******
http://www.stevensjohnsonsyndrome.com/c ... _advil.htm
GO TO WEBPAGE for links to these articles

Children's Motrin and Advil
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
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