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Medical Forum / General / General / January 2005

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[Ibuprofen (Advil, etc)] Lawsuit Claims Children's Motrin Causes Severe Side Effects

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john - 31 Dec 2004 18:18 GMT
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.
kyernurse - 01 Jan 2005 06:10 GMT
The child was given Motrin because she had a fever.  Courtesy of
e-madicine.com, here are the signs of Stevens-Johnson Syndrome...
 a.. Typically, the disease process begins with a nonspecific upper
respiratory tract infection.
   a.. This usually is part of a 1- to 14-day prodrome during which fever,
sore throat, chills, headache, and malaise may be present.
   a.. Vomiting and diarrhea are occasionally noted as part of the
prodrome.
 a.. Mucocutaneous lesions develop abruptly. Clusters of outbreaks last
from 2-4 weeks. The lesions are typically nonpruritic.
 a.. A history of fever or localized worsening should suggest a
superimposed infection; however, fever has been reported to occur in up to
85% of cases
So, considering the countless millions of doses of Ibuprofen given yearly
without producing Stevens-Johnson and looking at the fact that this child
had at least one of the symptoms of S-J prior to taking Ibuprofen, you may
conclude absolutely nothing.
Mark Probert - 01 Jan 2005 15:40 GMT
> The child was given Motrin because she had a fever.  Courtesy of
> e-madicine.com, here are the signs of Stevens-Johnson Syndrome...
[quoted text clipped - 13 lines]
> had at least one of the symptoms of S-J prior to taking Ibuprofen, you may
> conclude absolutely nothing.

Please take a moment to visit:

http://pages.ivillage.com/vaccinesupport/antivaxsites.html

and click on the whale.to website. The OP is the owner of that site, and,
after reading about it, and reading it, you will realize that John does not
require facts or logic to leap to an accusation showing that evidenced based
medicine is dangerous.

Please try not to confuse him with facts, as it only makes him post more
drivel.
David Wright - 02 Jan 2005 02:28 GMT
>Motrin is a brand name for Ibuprofen (Advil, etc)
>
[quoted text clipped - 9 lines]
>painkiller, claiming their daughter lost her eyesight and suffered other
>severe side effects after taking the medication.

And she may have.  Stevens-Johnson syndrome can be brought on my
NSAIDs.

>The lawsuit, filed on behalf of Sabrina Brierton Johnson of Los Angeles,
>seeks unspecified compensatory and punitive damages against New
[quoted text clipped - 7 lines]
>of negligence, breach of warranty and of concealing from consumers and
>doctors potential health risks of taking the flu and pain medication,

Pfui.  It's in the literature.  Nobody has covered it up.  It took me
all of 2 minutes to find it in PubMed, and the articles were not brand
new.

>"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.

And what good will this do?  The parents can then give aspirin, which
I believe can cause the same thing.  But it's incredibly rare.  The
notion that this is being public-spirited is just nonsense.

>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.

"Design flaws?"  "Design flaws?"  What kind of crap is that?

 -- David Wright :: alphabeta at prodigy.net
    These are my opinions only, but they're almost always correct.
      "If I have not seen as far as others, it is because giants
          were standing on my shoulders."  (Hal Abelson, MIT)
Nora Gr?ndal - 02 Jan 2005 22:41 GMT
"design flaws" have been commented on before, i diverse german-language
comments on racemic or enantiomers of medicines.
They comment on ibuprofen vs. the enantiomer dexibuprofen.
If Ibuprofen had been marketed now, it wouled not have been allowed.
All new medicines have to give a reason for why they do not market the
enantiomers now.
Racmics work differently on differen people.
Enantiomers work much more predictable with fewer side-effects.

(I did a web-search on dexibuprofen  because my mother had gotten it i
Austria, and it turned out a lot of interesting sites on the enantiomer
issue)
nora

> >Motrin is a brand name for Ibuprofen (Advil, etc)
> >
[quoted text clipped - 48 lines]
>        "If I have not seen as far as others, it is because giants
>            were standing on my shoulders."  (Hal Abelson, MIT)
David Wright - 03 Jan 2005 05:11 GMT
>"design flaws" have been commented on before, i diverse german-language
>comments on racemic or enantiomers of medicines.
[quoted text clipped - 4 lines]
>Racmics work differently on differen people.
>Enantiomers work much more predictable with fewer side-effects.

I would think so.  Has it been established that this is a problem with
commercial ibuprofen products?

>(I did a web-search on dexibuprofen  because my mother had gotten it i
>Austria, and it turned out a lot of interesting sites on the enantiomer
>issue)
>nora

That may be, but is it any more likely to cause Stevens-Johnson
syndrome?

 -- David Wright :: alphabeta at prodigy.net
    These are my opinions only, but they're almost always correct.
      "If I have not seen as far as others, it is because giants
          were standing on my shoulders."  (Hal Abelson, MIT)

>> >Motrin is a brand name for Ibuprofen (Advil, etc)
>> >
[quoted text clipped - 59 lines]
>>        "If I have not seen as far as others, it is because giants
>>            were standing on my shoulders."  (Hal Abelson, MIT)
 
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