Messages Messages Help
Reply | Forward | View Source | Unwrap Lines

Message 130939 of 130954 | Previous | Next [ Up Thread ] Message Index
Msg #
From: Teresa Binstock
Date: Wed Feb 16, 2005 9:02 pm
Subject: SJS: Warning Label on Children's Motrin? Dramatic Rise in Reported SJS Cases in Children

ADVERTISEMENT

February 10, 2005 05:14 PM US Eastern Timezone

Sabrina Johnson and SJS Foundation Founder Jean McCawley Will Hold a
Joint Press Conference on Thursday, February 17, 2005

for Thursday (Feb. 17)
http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&ne\
wsId=20050210005794&newsLang=en

--(BUSINESS WIRE)--They Seek the FDA's Help in Reinstating a Warning
Label on Children's Motrin about SJS; Jean McCawley Will Discuss
Dramatic Rise in Reported SJS Cases in Children

WHAT:

At 11:00 AM on Thursday, February 17th, Sabrina Brierton
Johnson, a 7-year old victim of Stevens-Johnson Syndrome
(SJS), and Mrs. Jean McCawley, founder of the Stevens Johnson
Syndrome Foundation, will hold a joint press conference in
the Lobby of the Hilton Washington North, 620 Perry Parkway,
Gaithersburg, MD. They seek the FDA's help in reinstating a
warning label on Children's Motrin about SJS. Mrs. McCawley
will discuss the dramatic rise in reported SJS cases in
children.

The press conference is being held relative to the FDA's
three-day meeting of the Arthritis Advisory Committee and the
Drug Safety and Risk Management Advisory Committee from
February 16-18, 2005 which will discuss the overall benefit
to risk considerations for COX-2 selective NSAIDS
(non-steroidal anti-inflammatory drugs) and related agents.
Sabrina's parents, Ken and Joan Brierton Johnson, and brother
Travis Johnson will attend, as well as her attorney Browne
Greene.

After the press conference, Sabrina Brierton Johnson will be
the first person to speak at the FDA's Open Public Hearing
segment of this meeting at approximately 1:00 PM in the
Ballrooms at the Hilton Washington DC North. She will ask
the FDA to reinstate a warning label about SJS that was
removed in 1995 when Children's Motrin was approved for
over-the-counter sale by the FDA. On behalf of the SJS
Foundation, Mrs. McCawley, through a written statement
submitted to the FDA for this Meeting, will advocate that
over-the-counter ibuprofen require a black box warning.

WHO:

Sabrina Brierton Johnson, from Topanga, CA., filed a
complaint for damages on December 28, 2004 against
Johnson & Johnson (NSYE:JNJ) in Los Angeles Superior
Court/Compton Division claiming that an allergic reaction to
taking Children's Motrin (Stevens-Johnson Syndrome) caused
her to become blind and photosensitive. She claims that
Defendants' failure to warn the public or educate the medical
community about the possible risk of SJS associated with
using over-the-counter Children's Motrin makes it an unsafe
product and dangerous to sell to consumers, which is why she
wants the FDA to reinstate a warning label. Sabrina Brierton
Johnson vs. Johnson & Johnson, et. al., Case Number TC
018540.

Mrs. Jean McCawley, from Westminster, CO., has an 11-year
old daughter, Julie, who became an SJS victim when she was
only 11-months old and who is now blind as a result. Mrs.
McCawley founded the SJS Foundation in 1996 to make
information about SJS more accessible to the public. She will
discuss the dramatic rise in reported SJS cases in children,
and the need to institute a Federal system to report and
track SJS cases.

WHEN:
Thursday, February 17, 2005

TIME:
11:00 AM Sabrina Brierton Johnson and Mrs. Jean McCawley
will hold a joint press conference in the Lobby of the Hilton
Washington DC North.